Mapp Biopharmaceutical, Inc. “Mapp” is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs.
Mapp Biopharmaceutical, Inc.
San Diego, California
Research Associate III - CHO Development
Job #24-01A
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs.
The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio through CMC, Nonclinical, Regulatory, Project Management, and Clinical activities consistent with Mapp's product development objectives.
The Research Associate III - CHO Development position is a technical position within ARDG. The Research Associate III - CHO Development will execute experimental studies, provides some technical direction to junior associates as well as perform general laboratory duties to support Mapp Scientists in meeting their research objectives.
Basic Qualifications
BA/BS Degree in a related scientific discipline with 4 years relevant research laboratory industry experience OR
MS Degree in a related scientific discipline with 2 years relevant research laboratory industry experience
Experience with mammalian cell suspension and tissue cultures
Experience in generating and screening stable clonal Chinese Hamster Ovary (CHO) cell lines
Experience with bench-scale bioreactor operation (mammalian culture)
Experience with protein purification, characterization, and analytical methods
Familiarity with and use of fully-automated instrumentation (BioHT, Cell Printer, etc.) for the selection of high-producing clones used in antibody discovery and cell line development
Excellent aseptic/sterile technique
Conceptual understanding of biological research related activities
Attention to detail
Preferred Qualifications
Experience in supervising junior associates and interns
Experience with pilot-scale (50L to 200L) mammalian cell culture upstream and downstream unit operations
Experience with mammalian cell culture perfusion bioreactor equipment setup and operation
Responsibilities
Performs generation, screening, and selection of high producing recombinant clonal CHO cell lines
Performs early-stage upstream process development of mammalian cultures for production of recombinant therapeutic proteins
Performs small-scale and pilot-scale bioreactor set-up, operation, and harvest activities
Prepares media, buffers and solutions to support cell culture and protein analysis assays
Performs purification and analysis of samples for upstream process development activities, including but not limit to POROS titer assay and spent media amino acid analysis.
Maintains detailed experimental records
Generates reports and documents as requested
Presents effectively and communicates work related results to supervisor and group
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. Mapp's anticipated pay scale for this position is $33.66 per hour - $40.87 per hour plus any applicable bonuses. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the candidate's level of education, and type and length of experience within the job and/or within the industry. Medical, dental, and vision insurance benefits are available to eligible employees and their families. Mapp also provides basic life insurance, short and long term disability, and a 401K plan that includes Company contributions to eligible employees. Full time employees will be provided 7 days of sick time, 14 paid holidays, and will also accrue 18 days of vacation throughout the calendar year.
This position is an on-site position located in Mapp's new state-of-the-art San Diego facility.
Mapp wants you to join their team and invites you to apply by submitting your information through https://mappbio.applicantpro.com/jobs/ . This job will remain open for twenty (20) days after being posted on Mapp's Job Openings website page (see link).
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
Mar 23, 2024
Full time
Research Associate III - CHO Development
Job #24-01A
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs.
The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio through CMC, Nonclinical, Regulatory, Project Management, and Clinical activities consistent with Mapp's product development objectives.
The Research Associate III - CHO Development position is a technical position within ARDG. The Research Associate III - CHO Development will execute experimental studies, provides some technical direction to junior associates as well as perform general laboratory duties to support Mapp Scientists in meeting their research objectives.
Basic Qualifications
BA/BS Degree in a related scientific discipline with 4 years relevant research laboratory industry experience OR
MS Degree in a related scientific discipline with 2 years relevant research laboratory industry experience
Experience with mammalian cell suspension and tissue cultures
Experience in generating and screening stable clonal Chinese Hamster Ovary (CHO) cell lines
Experience with bench-scale bioreactor operation (mammalian culture)
Experience with protein purification, characterization, and analytical methods
Familiarity with and use of fully-automated instrumentation (BioHT, Cell Printer, etc.) for the selection of high-producing clones used in antibody discovery and cell line development
Excellent aseptic/sterile technique
Conceptual understanding of biological research related activities
Attention to detail
Preferred Qualifications
Experience in supervising junior associates and interns
Experience with pilot-scale (50L to 200L) mammalian cell culture upstream and downstream unit operations
Experience with mammalian cell culture perfusion bioreactor equipment setup and operation
Responsibilities
Performs generation, screening, and selection of high producing recombinant clonal CHO cell lines
Performs early-stage upstream process development of mammalian cultures for production of recombinant therapeutic proteins
Performs small-scale and pilot-scale bioreactor set-up, operation, and harvest activities
Prepares media, buffers and solutions to support cell culture and protein analysis assays
Performs purification and analysis of samples for upstream process development activities, including but not limit to POROS titer assay and spent media amino acid analysis.
Maintains detailed experimental records
Generates reports and documents as requested
Presents effectively and communicates work related results to supervisor and group
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. Mapp's anticipated pay scale for this position is $33.66 per hour - $40.87 per hour plus any applicable bonuses. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the candidate's level of education, and type and length of experience within the job and/or within the industry. Medical, dental, and vision insurance benefits are available to eligible employees and their families. Mapp also provides basic life insurance, short and long term disability, and a 401K plan that includes Company contributions to eligible employees. Full time employees will be provided 7 days of sick time, 14 paid holidays, and will also accrue 18 days of vacation throughout the calendar year.
This position is an on-site position located in Mapp's new state-of-the-art San Diego facility.
Mapp wants you to join their team and invites you to apply by submitting your information through https://mappbio.applicantpro.com/jobs/ . This job will remain open for twenty (20) days after being posted on Mapp's Job Openings website page (see link).
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
Research Associate II
Job #21-35A
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs.
The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio with the CMC, Preclinical/Nonclinical (together, "Nonclinical"), Regulatory and Clinical development goals consistent with the product development objectives of Mapp.
The Research Associate II will support the Early (ERDG) and Advanced (ARDG) Research Development Groups by performing general laboratory duties as well as supporting laboratory personnel in meeting their research objectives.
Basic Qualifications:
BA or BS in a related scientific discipline
2 years of post degree research laboratory experience
Conceptual understanding of biological research related activities
Excellent aseptic technique for preparation of endotoxin-free buffers suitable for purification, antibody formulation, and injection into non-human primates
Proficient in the use of AKTA FPLC systems for protein purification
Proficient in the use of TFF system for ultra-/diafiltration
Demonstrated excellence in the following competency areas:
Attention to detail
Good general laboratory skills: accurate data collection, analysis, and familiarity molarity calculations and buffer formulation
Flexibility and curiosity
Strong desire to learn new laboratory skills
Demonstrated skill in the following areas:
Maintains notebooks, databases, and physical banks of all pertinent contributions
Ability to work independently and effectively troubleshoot experimental strategies in the laboratory
Responsibilities
Conducts purification of monoclonal antibodies from multiple protein expression platforms using Protein A, Capto Q, and other polishing columns on AKTA FPLC systems
Performs Tangential Flow Filtration (TFF) to concentrate and/or buffer exchange large volumes of purified monoclonal antibody
Prepares buffers and solutions to support protein purification
Maintains detailed records of all experiments performed
Performs general laboratory duties
Generates reports and documents as requested
Sets up and organizes lab space (set up lab equipment, lab benches, office furniture, manage waste)
Presents effectively and communicates work related results to supervisor and group
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will have the opportunity to work in Mapp's new state-of-the-art San Diego facility .
Mapp wants you to join their team and invites you to apply by submitting your information through https://mappbio.applicantpro.com/jobs/ .
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/j/2077071-307440
Nov 17, 2021
Full time
Research Associate II
Job #21-35A
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs.
The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio with the CMC, Preclinical/Nonclinical (together, "Nonclinical"), Regulatory and Clinical development goals consistent with the product development objectives of Mapp.
The Research Associate II will support the Early (ERDG) and Advanced (ARDG) Research Development Groups by performing general laboratory duties as well as supporting laboratory personnel in meeting their research objectives.
Basic Qualifications:
BA or BS in a related scientific discipline
2 years of post degree research laboratory experience
Conceptual understanding of biological research related activities
Excellent aseptic technique for preparation of endotoxin-free buffers suitable for purification, antibody formulation, and injection into non-human primates
Proficient in the use of AKTA FPLC systems for protein purification
Proficient in the use of TFF system for ultra-/diafiltration
Demonstrated excellence in the following competency areas:
Attention to detail
Good general laboratory skills: accurate data collection, analysis, and familiarity molarity calculations and buffer formulation
Flexibility and curiosity
Strong desire to learn new laboratory skills
Demonstrated skill in the following areas:
Maintains notebooks, databases, and physical banks of all pertinent contributions
Ability to work independently and effectively troubleshoot experimental strategies in the laboratory
Responsibilities
Conducts purification of monoclonal antibodies from multiple protein expression platforms using Protein A, Capto Q, and other polishing columns on AKTA FPLC systems
Performs Tangential Flow Filtration (TFF) to concentrate and/or buffer exchange large volumes of purified monoclonal antibody
Prepares buffers and solutions to support protein purification
Maintains detailed records of all experiments performed
Performs general laboratory duties
Generates reports and documents as requested
Sets up and organizes lab space (set up lab equipment, lab benches, office furniture, manage waste)
Presents effectively and communicates work related results to supervisor and group
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will have the opportunity to work in Mapp's new state-of-the-art San Diego facility .
Mapp wants you to join their team and invites you to apply by submitting your information through https://mappbio.applicantpro.com/jobs/ .
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/j/2077071-307440
Research Associate II
Job #21-34A
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs.
The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio with the CMC, Preclinical/Nonclinical (together, "Nonclinical"), Regulatory and Clinical development goals consistent with the product development objectives of Mapp.
The Research Associate II will support the Early (ERDG) and Advanced (ARDG) Research Development Groups by performing general laboratory duties as well as supporting laboratory personnel in meeting their research objectives.
Basic Qualifications:
BA or BS in a related scientific discipline
2 years of post degree research laboratory experience
Conceptual understanding of biological research related activities
Proficient in the use of HPLC systems and their respective software suites
Demonstrated excellence in the following competency areas:
Attention to detail
Good general laboratory skills: accurate data collection, analysis, and familiarity molarity calculations and buffer formulation
Flexibility and curiosity
Strong desire to learn new laboratory skills
Demonstrated skill in the following areas:
Maintains notebooks, databases, and physical banks of all pertinent contributions
Ability to work independently and effectively troubleshoot experimental strategies in the laboratory
Responsibilities
Performs various HPLC analytical methods such as Poros PrA, SEC, cIEX, HIC, etc on multiple HPLC systems and software
Performs basic protein analysis assays (SDS-PAGE, ELISA, Octet, etc.) and troubleshooting
Performs measurement of process related impurities using commercially available HCP and rPrA ELISA kits
Performs measurement of purity via CE-SDS or equivalent method
Prepares buffers and solutions to support protein purification and protein product analytics
Maintains detailed records of all experiments performed
Performs general laboratory duties
Generates reports and documents as requested
Sets up and organizes lab space (set up lab equipment, lab benches, office furniture, manage waste)
Presents effectively and communicates work related results to supervisor and group
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will have the opportunity to work in Mapp's new state-of-the-art San Diego facility .
Mapp wants you to join their team and invites you to apply by submitting your information through https://mappbio.applicantpro.com/jobs/ .
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/j/2077063-307440
Nov 17, 2021
Full time
Research Associate II
Job #21-34A
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs.
The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio with the CMC, Preclinical/Nonclinical (together, "Nonclinical"), Regulatory and Clinical development goals consistent with the product development objectives of Mapp.
The Research Associate II will support the Early (ERDG) and Advanced (ARDG) Research Development Groups by performing general laboratory duties as well as supporting laboratory personnel in meeting their research objectives.
Basic Qualifications:
BA or BS in a related scientific discipline
2 years of post degree research laboratory experience
Conceptual understanding of biological research related activities
Proficient in the use of HPLC systems and their respective software suites
Demonstrated excellence in the following competency areas:
Attention to detail
Good general laboratory skills: accurate data collection, analysis, and familiarity molarity calculations and buffer formulation
Flexibility and curiosity
Strong desire to learn new laboratory skills
Demonstrated skill in the following areas:
Maintains notebooks, databases, and physical banks of all pertinent contributions
Ability to work independently and effectively troubleshoot experimental strategies in the laboratory
Responsibilities
Performs various HPLC analytical methods such as Poros PrA, SEC, cIEX, HIC, etc on multiple HPLC systems and software
Performs basic protein analysis assays (SDS-PAGE, ELISA, Octet, etc.) and troubleshooting
Performs measurement of process related impurities using commercially available HCP and rPrA ELISA kits
Performs measurement of purity via CE-SDS or equivalent method
Prepares buffers and solutions to support protein purification and protein product analytics
Maintains detailed records of all experiments performed
Performs general laboratory duties
Generates reports and documents as requested
Sets up and organizes lab space (set up lab equipment, lab benches, office furniture, manage waste)
Presents effectively and communicates work related results to supervisor and group
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will have the opportunity to work in Mapp's new state-of-the-art San Diego facility .
Mapp wants you to join their team and invites you to apply by submitting your information through https://mappbio.applicantpro.com/jobs/ .
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/j/2077063-307440
Associate Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC)
Job #21-33A
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs.
The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio with the CMC, Preclinical/Nonclinical (together, "Nonclinical"), Regulatory and Clinical development goals consistent with the product development objectives of Mapp.
The Associate Director of CMC Regulatory Affairs will be responsible for developing, leading and executing CMC regulatory strategies and activities for the organization, including the preparation and filing of regulatory CMC submissions. This position is a hands-on role, providing both strategic and operational activities to support regulatory needs for multiple therapeutics at various stages of development. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads multi-functional technical teams in relation to regulatory expectations. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations. This position reports to the Head of Regulatory Affairs.
Basic Qualifications:
BS or BA Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Biologics, or another life-science related field - Advanced degree is preferred
10 years experience in the biotech industry or in a related field, or the equivalent combination of education and experience, with prior experience in a technical role in the CMC function, for example, as an analytical lead or downstream process (DSP), or upstream process (USP) lead for a mAb development program
2 years of experience in regulatory affairs in pharmaceutical/biotech industry with a focus on CMC activities and CMC Regulatory Affairs with demonstrated success and proven management by influence
Monoclonal antibodies or protein therapeutic IND and/or BLA filing experience
Experience with the FDA in regards to responding to CMC queries and/or requests
Demonstrated experience managing complex virtual and matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization
Demonstrated experience in developing effective and successful regulatory strategies for the CMC organization
Experience in leading the CMC activities of a mAb/protein therapeutic through the drug development process through IND and/or BLA submission
Experience in written and verbal interactions and negotiations with FDA related to CMC issues/submissions
Experience in establishing portfolio and program CMC Regulatory strategy from pre-Candidate Selection through Post-Licensure
Drug development technical familiarity in all aspects of CMC for Biologics
Ability to interpret, communicate, and present regulatory information in a clear, concise and timely manner
Ability to provide effective project communications, verbal and written, tailored for specific audiences
Ability to translate complex information into a logical and credible plan
Ability to work independently (with minimal supervision) as well as work in a team environment with changing timelines and priorities
Demonstrated organizational skills and attention to detail
Familiarity with eCTD requirements and e-submission formats/processes
Preferred Qualifications:
Advanced degree or equivalent in a related field
Experience in interacting and negotiating with non-US Regulatory Agencies
Experience in commercialization of monoclonal antibody therapies
Experience with post-approval change management, comparability assessment, post-marketing commitments and overall product life cycle management
Experience with FDA Animal Rule requirements for licensing drugs
Experience with US government acquisition and procurement contracting and Project Management deliverables
Experience in supporting US Government grant or proposal planning and writing
Previous experience establishing effective working relationships in a virtual environment
Previous experience developing drugs for rare diseases/Orphan drugs and/or antivirals
Previous experience supporting emergency use/expanded access interactions with FDA and other regulatory bodies
Previous experience working with regulatory authorities in developing countries and in resource limited environments
Previous experience developing good working relationships with regulators at all levels of the FDA especially in CMC related areas
Ability to effectively work remote/virtual (if applicable) using telecons and web conferences to both interact with product development teams, direct reports, and senior management
Responsibilities
Ensures that all CMC regulatory goals are met and are in compliance with current industry standards and global regulations and are effectively networked with government funding stakeholders
Serves as the global steward of CMC Regulatory Affairs processes, procedures, and tools to facilitate effective execution of the regulatory function across the CMC organization
Participates in the development of regulatory strategies for the company as well as for product development teams
Drafts regulatory submissions pertaining to CMC development and assists technical team members in compilation of relevant material to support overall product development strategies
Acts as a key member of the product development, CMC and regulatory leadership teams at Mapp
Serves as the CMC regulatory representative to drug substance/product development teams and provide input to key development decision and documents
Acts as the primary point of contact with Health Authorities on CMC matters. Facilitates CMC interactions, presentations and negotiations and is responsible for the oversight of CMC interactions with Health Authorities as needed
Develops effective working relationships with the regulators at the leadership level and not just the transactional level
Interprets and communicates FDA (and other regulatory body) messages pertaining to CMC matters, expectations and decisions to internal and external stakeholders (including CRO's, CMO's, consultants and contractors) on a timely basis
Advises senior management on the impact the changing regulatory environment can/will have on Mapp business and projects
Participates in portfolio and program-level strategy establishment, decision-making, issue resolution, communications strategy, and resourcing/capacity evaluations as the CMC Regulatory Affairs representative
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will have the opportunity to work in Mapp's new state-of-the-art San Diego facility, or, if your job responsibilities allow, you may choose to work remotely (outside of the State of Colorado.). Willingness to Travel (~<20% = Domestic Travel + ~<10% International Travel) will be required for this position. Mapp wants you to join their team and invites you to apply by submitting your information through https://mappbio.applicantpro.com/jobs/ .
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/j/2071703-307440
Nov 17, 2021
Full time
Associate Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC)
Job #21-33A
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs.
The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio with the CMC, Preclinical/Nonclinical (together, "Nonclinical"), Regulatory and Clinical development goals consistent with the product development objectives of Mapp.
The Associate Director of CMC Regulatory Affairs will be responsible for developing, leading and executing CMC regulatory strategies and activities for the organization, including the preparation and filing of regulatory CMC submissions. This position is a hands-on role, providing both strategic and operational activities to support regulatory needs for multiple therapeutics at various stages of development. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads multi-functional technical teams in relation to regulatory expectations. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations. This position reports to the Head of Regulatory Affairs.
Basic Qualifications:
BS or BA Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Biologics, or another life-science related field - Advanced degree is preferred
10 years experience in the biotech industry or in a related field, or the equivalent combination of education and experience, with prior experience in a technical role in the CMC function, for example, as an analytical lead or downstream process (DSP), or upstream process (USP) lead for a mAb development program
2 years of experience in regulatory affairs in pharmaceutical/biotech industry with a focus on CMC activities and CMC Regulatory Affairs with demonstrated success and proven management by influence
Monoclonal antibodies or protein therapeutic IND and/or BLA filing experience
Experience with the FDA in regards to responding to CMC queries and/or requests
Demonstrated experience managing complex virtual and matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization
Demonstrated experience in developing effective and successful regulatory strategies for the CMC organization
Experience in leading the CMC activities of a mAb/protein therapeutic through the drug development process through IND and/or BLA submission
Experience in written and verbal interactions and negotiations with FDA related to CMC issues/submissions
Experience in establishing portfolio and program CMC Regulatory strategy from pre-Candidate Selection through Post-Licensure
Drug development technical familiarity in all aspects of CMC for Biologics
Ability to interpret, communicate, and present regulatory information in a clear, concise and timely manner
Ability to provide effective project communications, verbal and written, tailored for specific audiences
Ability to translate complex information into a logical and credible plan
Ability to work independently (with minimal supervision) as well as work in a team environment with changing timelines and priorities
Demonstrated organizational skills and attention to detail
Familiarity with eCTD requirements and e-submission formats/processes
Preferred Qualifications:
Advanced degree or equivalent in a related field
Experience in interacting and negotiating with non-US Regulatory Agencies
Experience in commercialization of monoclonal antibody therapies
Experience with post-approval change management, comparability assessment, post-marketing commitments and overall product life cycle management
Experience with FDA Animal Rule requirements for licensing drugs
Experience with US government acquisition and procurement contracting and Project Management deliverables
Experience in supporting US Government grant or proposal planning and writing
Previous experience establishing effective working relationships in a virtual environment
Previous experience developing drugs for rare diseases/Orphan drugs and/or antivirals
Previous experience supporting emergency use/expanded access interactions with FDA and other regulatory bodies
Previous experience working with regulatory authorities in developing countries and in resource limited environments
Previous experience developing good working relationships with regulators at all levels of the FDA especially in CMC related areas
Ability to effectively work remote/virtual (if applicable) using telecons and web conferences to both interact with product development teams, direct reports, and senior management
Responsibilities
Ensures that all CMC regulatory goals are met and are in compliance with current industry standards and global regulations and are effectively networked with government funding stakeholders
Serves as the global steward of CMC Regulatory Affairs processes, procedures, and tools to facilitate effective execution of the regulatory function across the CMC organization
Participates in the development of regulatory strategies for the company as well as for product development teams
Drafts regulatory submissions pertaining to CMC development and assists technical team members in compilation of relevant material to support overall product development strategies
Acts as a key member of the product development, CMC and regulatory leadership teams at Mapp
Serves as the CMC regulatory representative to drug substance/product development teams and provide input to key development decision and documents
Acts as the primary point of contact with Health Authorities on CMC matters. Facilitates CMC interactions, presentations and negotiations and is responsible for the oversight of CMC interactions with Health Authorities as needed
Develops effective working relationships with the regulators at the leadership level and not just the transactional level
Interprets and communicates FDA (and other regulatory body) messages pertaining to CMC matters, expectations and decisions to internal and external stakeholders (including CRO's, CMO's, consultants and contractors) on a timely basis
Advises senior management on the impact the changing regulatory environment can/will have on Mapp business and projects
Participates in portfolio and program-level strategy establishment, decision-making, issue resolution, communications strategy, and resourcing/capacity evaluations as the CMC Regulatory Affairs representative
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will have the opportunity to work in Mapp's new state-of-the-art San Diego facility, or, if your job responsibilities allow, you may choose to work remotely (outside of the State of Colorado.). Willingness to Travel (~<20% = Domestic Travel + ~<10% International Travel) will be required for this position. Mapp wants you to join their team and invites you to apply by submitting your information through https://mappbio.applicantpro.com/jobs/ .
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/j/2071703-307440
Mapp Biopharmaceutical, Inc.
San Diego, CA, USA 92121
Scientist I - Job #21-31A
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs.
The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio with the CMC, Preclinical/Nonclinical (together, "Nonclinical"), Regulatory and Clinical development goals consistent with the product development objectives of Mapp.
The Scientist I will work within the Antibody Discovery and Research Group within ERDG which is responsible for isolating novel antibodies that may be used in future drug products. The Scientist I is responsible for executing a variety of protocols related to antibody discovery, as well as supporting ERDG laboratory personnel in meeting their research objectives.
Basic Qualifications:
BA/BS or MS in a relevant scientific discipline
10 years of experience with a BA/BS or 7 years of experience with a MS in a research laboratory environment
Ability to independently contribute to scientific research programs in the Antibody Discovery and Research Group
Demonstrated excellence in the design and cloning of expression vectors for multiple recombinant cell expression systems
Prior experience expressing and purifying recombinant proteins
Proven ability to reliably manage samples in high-throughput format
Prior phage display and panning experience
Ability to work independently and effectively troubleshoot experimental strategies in the laboratory
Attention to detail and keen scientific observation
Preferred Qualifications:
Previous experience with next-generation sequencing
Experience operating a robotic liquid handler
Experience running Akta FPLCs and GE unicorn software
Development of novel technology and/or methodology to increase laboratory capabilities
Authorship on multiple scientific publications in respected peer reviewed journals
Contributed to the preparation of government grant and/or contract proposals
Responsibilities
Designs and executes critical experiments independently
Contributes to data and analyses to support writing of publications and grant applications
Develops novel technology and/or methodology to increase laboratory capabilities
Performs high-throughput/plate-based assays for a variety of platforms reliably, maintaining sample integrity
Phage display
Builds phage display libraries
Develops and executes workflows for phage panning/enrichment
Sequences phage of interest
Recombinant protein expression and purification from bacteria
Optimizes expression constructs for protein stability, solubility and expression levels
Familiar with the operation of an AKTA Xpress, AKTA Pure, and/or AKTA Avant FPLC and Cytiva unicorn software
Familiar with multiple types of affinity chromatography media and their applications
Performs analytical assays
UV Spectrophotometry for determining protein concentration
Uses a combination of SEC, SDS-PAGE and/or western blots to evaluate protein composition, stability or structural integrity
Operates a ForteBio Octet 96 (BLI) for quantitative and/or kinetics-based assays
Manages multiple projects concurrently in the laboratory
Anticipates and executes experiments to move projects forward without prompting
Communicates effectively with and manages collaborating scientists to ensure projects continue to progress efficiently toward deliverables
Maintains a detailed and legible record of all experiments performed
Presents and communicates experimental results to the group effectively
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will have the opportunity to work in Mapp's new state-of-the-art San Diego facility. Mapp wants you to join their team and invites you to apply by submitting your information through https://mappbio.applicantpro.com/jobs/ .
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/j/2050777-307440
Nov 01, 2021
Full time
Scientist I - Job #21-31A
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs.
The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio with the CMC, Preclinical/Nonclinical (together, "Nonclinical"), Regulatory and Clinical development goals consistent with the product development objectives of Mapp.
The Scientist I will work within the Antibody Discovery and Research Group within ERDG which is responsible for isolating novel antibodies that may be used in future drug products. The Scientist I is responsible for executing a variety of protocols related to antibody discovery, as well as supporting ERDG laboratory personnel in meeting their research objectives.
Basic Qualifications:
BA/BS or MS in a relevant scientific discipline
10 years of experience with a BA/BS or 7 years of experience with a MS in a research laboratory environment
Ability to independently contribute to scientific research programs in the Antibody Discovery and Research Group
Demonstrated excellence in the design and cloning of expression vectors for multiple recombinant cell expression systems
Prior experience expressing and purifying recombinant proteins
Proven ability to reliably manage samples in high-throughput format
Prior phage display and panning experience
Ability to work independently and effectively troubleshoot experimental strategies in the laboratory
Attention to detail and keen scientific observation
Preferred Qualifications:
Previous experience with next-generation sequencing
Experience operating a robotic liquid handler
Experience running Akta FPLCs and GE unicorn software
Development of novel technology and/or methodology to increase laboratory capabilities
Authorship on multiple scientific publications in respected peer reviewed journals
Contributed to the preparation of government grant and/or contract proposals
Responsibilities
Designs and executes critical experiments independently
Contributes to data and analyses to support writing of publications and grant applications
Develops novel technology and/or methodology to increase laboratory capabilities
Performs high-throughput/plate-based assays for a variety of platforms reliably, maintaining sample integrity
Phage display
Builds phage display libraries
Develops and executes workflows for phage panning/enrichment
Sequences phage of interest
Recombinant protein expression and purification from bacteria
Optimizes expression constructs for protein stability, solubility and expression levels
Familiar with the operation of an AKTA Xpress, AKTA Pure, and/or AKTA Avant FPLC and Cytiva unicorn software
Familiar with multiple types of affinity chromatography media and their applications
Performs analytical assays
UV Spectrophotometry for determining protein concentration
Uses a combination of SEC, SDS-PAGE and/or western blots to evaluate protein composition, stability or structural integrity
Operates a ForteBio Octet 96 (BLI) for quantitative and/or kinetics-based assays
Manages multiple projects concurrently in the laboratory
Anticipates and executes experiments to move projects forward without prompting
Communicates effectively with and manages collaborating scientists to ensure projects continue to progress efficiently toward deliverables
Maintains a detailed and legible record of all experiments performed
Presents and communicates experimental results to the group effectively
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will have the opportunity to work in Mapp's new state-of-the-art San Diego facility. Mapp wants you to join their team and invites you to apply by submitting your information through https://mappbio.applicantpro.com/jobs/ .
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/j/2050777-307440
Mapp Biopharmaceutical, Inc.
San Diego, CA, USA 92121
Controller
Job #21-18R
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs.
The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of robust portfolio with the CMC, Preclinical/Nonclinical (together, "Nonclinical"), Regulatory and Clinical development goals consistent with the product development objectives of Mapp.
The Controller role will review established systems to run an accounting system that is compliant with both GAAP and the Federal Acquisition Regulation (FAR) and aligns with the needs of a Biotech/Biopharmaceutical company.
Basic Qualifications:
Bachelor's Degree in Accounting or Business Administration or equivalent
Certified Public Accountant (CPA) designation
10+ years accounting or finance or related experience
Experience with managing company finances individually and with a team
Experience with multiple accounting systems
Strong audit background (i.e. audit lead for external financial audit)
Knowledge of GAAP
Strong analytical, problem-solving and decision-making capabilities
Must be detail oriented with strong organizational skills
Experience operating in complex professional environments with a variety of internal and external stakeholders across multiple organizations
Excellent verbal, interpersonal, and written communication and presentation skills
Sound business ethics, including the protection of proprietary, confidential and classified information
Strong Experience with MS Office Suite (Outlook, Word, Excel, PowerPoint) (emphasis on Excel)
Preferred Qualifications:
Knowledge of Unanet accounting system
Experience in a government funded environment
Experience in the Biotech or Biopharmaceutical environment
Experience with Government funding (contracts/grants) and understanding of the FAR
Responsibilities
Develops and implements accounting procedures by analyzing current procedures and recommending changes ensuring compliance with appropriate regulations
Directs the overall accounting, tax and finance operations, including overseeing transaction processing systems
Remains current on audit best practices; and state, federal and local law regarding company operations
Supervises Accounting personnel
Oversees Accounts Payable (AP), signs checks and authorizes wires
Supervises outsourced financial activities
Oversees payroll, outsourced to third party
Oversees tax filings, managing outside CPA
Represents company to banks, financial partners, institutions, auditors and officials
Directs the overall accounting, tax and finance operations, including overseeing transaction processing systems
Performs monthly accounting and financial analysis by developing spreadsheet reports
Prepares GL entries by maintaining records and files; prepares monthly financial statements
Prepares supporting schedules for internal and external audit
Performs month-end and year-end closing, present financial statements to executive management
Answers accounting and financial questions by researching and interpreting data
Aligns Biotech and Pharmaceutical development needs with regulatory compliance
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in San Diego. Mapp wants you to join their team and invites you to apply.
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/j/1836614-307440
Jun 25, 2021
Full time
Controller
Job #21-18R
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs.
The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of robust portfolio with the CMC, Preclinical/Nonclinical (together, "Nonclinical"), Regulatory and Clinical development goals consistent with the product development objectives of Mapp.
The Controller role will review established systems to run an accounting system that is compliant with both GAAP and the Federal Acquisition Regulation (FAR) and aligns with the needs of a Biotech/Biopharmaceutical company.
Basic Qualifications:
Bachelor's Degree in Accounting or Business Administration or equivalent
Certified Public Accountant (CPA) designation
10+ years accounting or finance or related experience
Experience with managing company finances individually and with a team
Experience with multiple accounting systems
Strong audit background (i.e. audit lead for external financial audit)
Knowledge of GAAP
Strong analytical, problem-solving and decision-making capabilities
Must be detail oriented with strong organizational skills
Experience operating in complex professional environments with a variety of internal and external stakeholders across multiple organizations
Excellent verbal, interpersonal, and written communication and presentation skills
Sound business ethics, including the protection of proprietary, confidential and classified information
Strong Experience with MS Office Suite (Outlook, Word, Excel, PowerPoint) (emphasis on Excel)
Preferred Qualifications:
Knowledge of Unanet accounting system
Experience in a government funded environment
Experience in the Biotech or Biopharmaceutical environment
Experience with Government funding (contracts/grants) and understanding of the FAR
Responsibilities
Develops and implements accounting procedures by analyzing current procedures and recommending changes ensuring compliance with appropriate regulations
Directs the overall accounting, tax and finance operations, including overseeing transaction processing systems
Remains current on audit best practices; and state, federal and local law regarding company operations
Supervises Accounting personnel
Oversees Accounts Payable (AP), signs checks and authorizes wires
Supervises outsourced financial activities
Oversees payroll, outsourced to third party
Oversees tax filings, managing outside CPA
Represents company to banks, financial partners, institutions, auditors and officials
Directs the overall accounting, tax and finance operations, including overseeing transaction processing systems
Performs monthly accounting and financial analysis by developing spreadsheet reports
Prepares GL entries by maintaining records and files; prepares monthly financial statements
Prepares supporting schedules for internal and external audit
Performs month-end and year-end closing, present financial statements to executive management
Answers accounting and financial questions by researching and interpreting data
Aligns Biotech and Pharmaceutical development needs with regulatory compliance
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in San Diego. Mapp wants you to join their team and invites you to apply.
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/j/1836614-307440
Director, Quality Assurance GMP
Job #20-06A
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases. The Early Research and Development Group (ER&DG) and the Advanced Research and Development Group (AR&DG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of robust portfolio with the CMC, Toxicology and Clinical development goals consistent with the product development objectives of Mapp. Partnering with the CMC, non-clinical, and clinical development functions at Mapp, the Director for QA-GMP is a hands-on, roll-up your sleeves-strategic thinking employee functioning as a key member of the Quality Assurance team. Additionally, the successful candidate partners with Principal Investigators and the program team to deliver on Mapp's portfolio.
Basic Qualifications:
BABS Degree in Science with 10+ Years of Quality Assurance Experience (GMP required and additional GLP and GCP experience is an advantage).
10+ Years of Biologics/mAb Product Development and/or commercial manufacturing experience in a small to mid-sized biopharmaceutical company
Direct experience in providing QA oversight for cGMP manufacturing operations
Knowledge of drug development regulations such as the GCP's, GMPs and GLPs
Travel required (up to 25% domestic and international)
Previous experience with auditing biological and parenteral manufacturing facilities
Experience overseeing GMPs (as a Sponsor) at third-party locations in a small or mid-sized Biotechnology company
Preferred Qualifications:
Previous technical CMC experience with monoclonal antibody Drug Substance and/or Drug Product development/commercialization
Experience across all phases of biologic drug development (Clinical phases 1 thru 4 of drug development) preferred
Understands patient dosing on a mg/kg basis
Experience in a technical or QA role for the oversight or execution of monoclonal antibody Drug Substance and Drug Product manufacture is an asset
Previous experience supporting Pre-approval Inspections is desirable
Experience working virtual preferred
Responsibilities
Mapp Focused
Provides quality oversight for all cGMP manufacturing and release
Partners with all CMC functional team members to assure the advancement of the integrated CMC program scope or work
Partners with Clinical to provide quality oversight for clinical Drug Product
Participates in Program team meetings and stakeholder meetings as required
Partners in the development of the Quality strategy for GMPs and ensures deployment as approved by senior management
Contributes to the development and maintenance of the global quality systems in line with current regulatory requirements, meeting US FDA and European requirements, and others as needed
Supports deployment and implementation of GxP practices, policies and procedures
Collaborates with, and supports Corporate leadership
Acts as point of contact with regulatory authorities regarding quality-related issues at third party GMP manufacturing sites.
Partners with the Mapp QA group to establish and provide support for the development and harmonization of quality standards and processes, compliant policies, procedures and specifications
Maintains good relationship with Regulatory bodies as well as FDA inspectors
Reports all critical and relevant Quality compliance matters to the Vice President of Quality Assurance
Ensures required Quality Assurance management and quality expertise is available and effective for operations
Ensures effective internal and external GxP audit programs are deployed and effective with focus on GMP manufacturing sites.
Ensures Quality Assurance review and approval/rejection of all GMP related procedures, documents and records
Ensures where appropriate, that all Mapp personnel training, investigation, deviation actions, critical documentation and audit actions are completed on time
Ensures escalation to the Vice President of Quality Assurance and leadership of all critical concerns from the site related to product quality issues encountered at sites and the partner's quality system
Ensures that QA team maintains appropriate independence in order to ensure that there is no conflict of interest between regulatory requirements and day-to-day operational priorities
Ensures risk management principles, the essence of ICHQ10 and a continuous improvement culture are built into QA ways of working
Assists in constructing annual GxP training
Authors Standard Operating Procedures (SOP's) related to GxP and other QMS related activities
May have limited supervisory duties
May be assigned limited GxP duties outside of GMPs
Partner Focused
Provides QA oversight for all cGMP activities at the GMP manufacturing locations, packaging and labeling sites including, but not limited to, review and approval of all manufacturing documentation (batch records, process flow documents etc. ) and final release of final material
Supports the evaluation/selection potential future contract manufacturing organizations (CMOs)
Provides quality input in technology transfers to CMOs
Ensures quality agreements are in place at CMOs to ensure adherence to regulatory requirements
Provides QA support for identification, risk assessments, action plans, remediation plans for any GMP manufacturing and test deviations and investigations
Functions as Lead Auditor for GMP manufacturing, test, packaging, labeling, and storage vendors and supports other functional vendor audits
Influences a strong quality and compliance culture at the partner and contractor sites
Acts as a SME on any GMP issue at the partner and clinical trial sites
Contributes as subject matter expert for matters relating to formal quality management and regulatory compliance at Mapp's partner sites in collaboration with the Vice President of Quality Assurance
Partners with key customers on Quality strategy and Quality system execution
Acts as primary contact for discussions on Quality matters with key customers and contractors
Acts as point of contact with regulatory authorities regarding quality-related issues at manufacturing sites
Deploys the quality and compliance strategy for to deliver strategic business objectives at partner site in conjunction with the applicable site
Ensures the existence/establishment of effective manufacturing control at partner sites
Ensures enforcement of investigation of non-conformances, as well as fraud
Ensures the manufacturing sites are "audit ready" and compliant at all times
Ensures where appropriate that all personnel training, investigation, deviation actions, critical documentation and audit actions at the manufacturing sites are completed on time
Writes audit plans and other documents
Maintains confidentiality
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in San Diego, CA or may have the opportunity to work remotely. Willingness to travel domestically and internationally approximately 25% will be required for this position. Mapp wants you to join their team and invites you to apply.
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/openings/mappbio/jobs/1464320-307440
Jul 29, 2020
Full time
Director, Quality Assurance GMP
Job #20-06A
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases. The Early Research and Development Group (ER&DG) and the Advanced Research and Development Group (AR&DG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of robust portfolio with the CMC, Toxicology and Clinical development goals consistent with the product development objectives of Mapp. Partnering with the CMC, non-clinical, and clinical development functions at Mapp, the Director for QA-GMP is a hands-on, roll-up your sleeves-strategic thinking employee functioning as a key member of the Quality Assurance team. Additionally, the successful candidate partners with Principal Investigators and the program team to deliver on Mapp's portfolio.
Basic Qualifications:
BABS Degree in Science with 10+ Years of Quality Assurance Experience (GMP required and additional GLP and GCP experience is an advantage).
10+ Years of Biologics/mAb Product Development and/or commercial manufacturing experience in a small to mid-sized biopharmaceutical company
Direct experience in providing QA oversight for cGMP manufacturing operations
Knowledge of drug development regulations such as the GCP's, GMPs and GLPs
Travel required (up to 25% domestic and international)
Previous experience with auditing biological and parenteral manufacturing facilities
Experience overseeing GMPs (as a Sponsor) at third-party locations in a small or mid-sized Biotechnology company
Preferred Qualifications:
Previous technical CMC experience with monoclonal antibody Drug Substance and/or Drug Product development/commercialization
Experience across all phases of biologic drug development (Clinical phases 1 thru 4 of drug development) preferred
Understands patient dosing on a mg/kg basis
Experience in a technical or QA role for the oversight or execution of monoclonal antibody Drug Substance and Drug Product manufacture is an asset
Previous experience supporting Pre-approval Inspections is desirable
Experience working virtual preferred
Responsibilities
Mapp Focused
Provides quality oversight for all cGMP manufacturing and release
Partners with all CMC functional team members to assure the advancement of the integrated CMC program scope or work
Partners with Clinical to provide quality oversight for clinical Drug Product
Participates in Program team meetings and stakeholder meetings as required
Partners in the development of the Quality strategy for GMPs and ensures deployment as approved by senior management
Contributes to the development and maintenance of the global quality systems in line with current regulatory requirements, meeting US FDA and European requirements, and others as needed
Supports deployment and implementation of GxP practices, policies and procedures
Collaborates with, and supports Corporate leadership
Acts as point of contact with regulatory authorities regarding quality-related issues at third party GMP manufacturing sites.
Partners with the Mapp QA group to establish and provide support for the development and harmonization of quality standards and processes, compliant policies, procedures and specifications
Maintains good relationship with Regulatory bodies as well as FDA inspectors
Reports all critical and relevant Quality compliance matters to the Vice President of Quality Assurance
Ensures required Quality Assurance management and quality expertise is available and effective for operations
Ensures effective internal and external GxP audit programs are deployed and effective with focus on GMP manufacturing sites.
Ensures Quality Assurance review and approval/rejection of all GMP related procedures, documents and records
Ensures where appropriate, that all Mapp personnel training, investigation, deviation actions, critical documentation and audit actions are completed on time
Ensures escalation to the Vice President of Quality Assurance and leadership of all critical concerns from the site related to product quality issues encountered at sites and the partner's quality system
Ensures that QA team maintains appropriate independence in order to ensure that there is no conflict of interest between regulatory requirements and day-to-day operational priorities
Ensures risk management principles, the essence of ICHQ10 and a continuous improvement culture are built into QA ways of working
Assists in constructing annual GxP training
Authors Standard Operating Procedures (SOP's) related to GxP and other QMS related activities
May have limited supervisory duties
May be assigned limited GxP duties outside of GMPs
Partner Focused
Provides QA oversight for all cGMP activities at the GMP manufacturing locations, packaging and labeling sites including, but not limited to, review and approval of all manufacturing documentation (batch records, process flow documents etc. ) and final release of final material
Supports the evaluation/selection potential future contract manufacturing organizations (CMOs)
Provides quality input in technology transfers to CMOs
Ensures quality agreements are in place at CMOs to ensure adherence to regulatory requirements
Provides QA support for identification, risk assessments, action plans, remediation plans for any GMP manufacturing and test deviations and investigations
Functions as Lead Auditor for GMP manufacturing, test, packaging, labeling, and storage vendors and supports other functional vendor audits
Influences a strong quality and compliance culture at the partner and contractor sites
Acts as a SME on any GMP issue at the partner and clinical trial sites
Contributes as subject matter expert for matters relating to formal quality management and regulatory compliance at Mapp's partner sites in collaboration with the Vice President of Quality Assurance
Partners with key customers on Quality strategy and Quality system execution
Acts as primary contact for discussions on Quality matters with key customers and contractors
Acts as point of contact with regulatory authorities regarding quality-related issues at manufacturing sites
Deploys the quality and compliance strategy for to deliver strategic business objectives at partner site in conjunction with the applicable site
Ensures the existence/establishment of effective manufacturing control at partner sites
Ensures enforcement of investigation of non-conformances, as well as fraud
Ensures the manufacturing sites are "audit ready" and compliant at all times
Ensures where appropriate that all personnel training, investigation, deviation actions, critical documentation and audit actions at the manufacturing sites are completed on time
Writes audit plans and other documents
Maintains confidentiality
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in San Diego, CA or may have the opportunity to work remotely. Willingness to travel domestically and internationally approximately 25% will be required for this position. Mapp wants you to join their team and invites you to apply.
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/openings/mappbio/jobs/1464320-307440