McRAles LLC
Remote
This is a temp to perm part-time position.
McRales LLC helps businesses engage with the people that matter most to their growth. We amplify what companies are doing well and fill in the gaps where these businesses need the most help. Leveraging strategy and tactics that take them through, web design, email marketing, social media marketing, local SEO, etc. Our guiding mantra: "Simplify the process. Automate where you can. Don't fight the template."
About our ideal candidate:
We are looking for a well-rounded digital marketing assistant to help us expand our product offerings. The initial scope of this project will focus on helping us organize our own strategy and message. Later on, as you become part of our team we will bring you into the fold of our other client projects. The key tasks will center on website design, web content, creating digital ad copy, and creating engaging email copy.
Key Skills:
Copywriting - Must have experience writing copy for blogs, websites, digital ads, and emails. Website Design - Creative person with experience in using drag and drop type of website builders. (Duda, Squarespace, Wix, etc.) Html, and CSS not required but very much appreciated. Digital Advertising - Needs to be familiar with Facebook advertising, and other social ad platforms Graphic Design - Basic knowledge is required. Email Marketing skills SEO - Basic to intermediate SEO skills.
Extra Credit RESTful API knowledge is a big plus
Requirements: Socratic Learner Entrepreneurial spirit Problem Solver Please include a sample of past work when you submit your resume. 2 years experience minimum, but we are flexible for the right person.
This is a temp to perm position. Whether it becomes permanent is up to you.
This is a temp to perm part-time position.
McRales LLC helps businesses engage with the people that matter most to their growth. We amplify what companies are doing well and fill in the gaps where these businesses need the most help. Leveraging strategy and tactics that take them through, web design, email marketing, social media marketing, local SEO, etc. Our guiding mantra: "Simplify the process. Automate where you can. Don't fight the template."
About our ideal candidate:
We are looking for a well-rounded digital marketing assistant to help us expand our product offerings. The initial scope of this project will focus on helping us organize our own strategy and message. Later on, as you become part of our team we will bring you into the fold of our other client projects. The key tasks will center on website design, web content, creating digital ad copy, and creating engaging email copy.
Key Skills:
Copywriting - Must have experience writing copy for blogs, websites, digital ads, and emails. Website Design - Creative person with experience in using drag and drop type of website builders. (Duda, Squarespace, Wix, etc.) Html, and CSS not required but very much appreciated. Digital Advertising - Needs to be familiar with Facebook advertising, and other social ad platforms Graphic Design - Basic knowledge is required. Email Marketing skills SEO - Basic to intermediate SEO skills.
Extra Credit RESTful API knowledge is a big plus
Requirements: Socratic Learner Entrepreneurial spirit Problem Solver Please include a sample of past work when you submit your resume. 2 years experience minimum, but we are flexible for the right person.
This is a temp to perm position. Whether it becomes permanent is up to you.
League of Conservation Voters
Washington, DC
Title: Deputy National Field Director
Department: Campaigns
Status: Exempt, short term 7-month position
Reports to: National Organizing Director
Positions Reporting to this Position: None
Location: Washington, DC
General Description :
LCV believes our earth is worth fighting for because everyone has a right to clean air, water, and a safe, healthy community. To ensure those rights are protected, we help people use their power to shape policy, hold politicians and polluters accountable, and influence elections.
Our over 2 million members, our volunteers and staff, and our more than 30 state affiliates (together, the Conservation Voter Movement) work for a more just and equitable democracy, where people—not polluters—determine our future. This movement is an influential national network with unparalleled influence in Washington, DC, in state capitals, and in communities around the country. We are unmatched in our ability to ensure meaningful action on our key issues. We aim to bring people and communities together across racial, geographic, political, religious, economic and other differences toward collective goals instead of dividing us from one another.
LCV is hiring a Deputy National Field Director, to support and oversee both non-electoral issue and independent expenditure electoral field programs. The Deputy National Field Director will support the National Organizing Director with the design and implementation of canvass programs. The position will collaborate with the Data and Analytics team to monitor program success and work with the broader team to achieve non-electoral and electoral goals. The position will also work closely with the Campaigns’ issue organizing team, supporting the execution of organizing efforts advocating for just and equitable climate policy. The Deputy National Field Director will work with state affiliate partners and coalition members on both issue and electoral efforts.
Responsibilities :
Work closely with national LCV staff and state LCVs to develop and oversee the implementation of all organizing programs for issue campaigns that engage community members and advocate for just and equitable federal environmental policy priorities.
Work with LCV staff and state LCVs to develop and oversee the implementation of field components of independent expenditure electoral campaigns, including potential vote by mail sign up, persuasion canvass or mobilization programs to increase turnout among youth and communities of color.
Develop and support implementation of remote and digital organizing tactics to educate and engage community members, with emphasis on these tactics in near term tactics to adapt to safer-at-home protocols.
Develop training and support materials for issue organizing programs to build necessary skills and abilities of program staff to engage racially diverse communities and explain intersection of policies and racial and environmental justice.
Help maintain relationships with coalition partners across the broader environmental, progressive, and electoral community and represent LCV’s interests at coalition meetings.
Work with the Campaigns’ Analytics and Data team to set and track all metrics related to organizing activities and progress in meeting goals.
Support creation of and manage review process for scripts and other field-related materials, ensuring that materials are culturally competent.
Ensure compliance and reporting of all field-related electoral activities working with the Legal and Finance departments.
Other duties as assigned.
Qualifications :
Work Experience : Required – 3-5 cycles or 4+ years experience in community, electoral, issue or labor organizing; 1 cycle or 2 years of experience managing and training teams representing a rich mix of talent, experience, backgrounds, and perspectives; Demonstrated experience tracking data in VAN or VoteBuilder. Demonstrated experience managing program staff remotely while building a strong team environment. Demonstrated experience implementing digital organizing tools, including peer-to-peer texting. Strongly Preferred - Experience working on an independent expenditure campaign. Preferred - Experience with youth organizing. Experience working with data models and scores; 1 cycle or 2 years of experience running paid canvass field programs.
Skills : Demonstrated ability to collaborate with colleagues and partner organizations. Demonstrated ability to represent organizational interests in coalitions. Ability to multitask without sacrificing quality of work. Ability to foster a collaborative team and results oriented work environment. Exceptional leadership, project management and coaching skills including supporting remote staff. Strong organizing skills, including a commitment to empowering activists and volunteers; creative and proactive in identifying and pursuing organizing opportunities. Must possess strong written and oral communication skills. Fluency in VAN and Microsoft Office Suite; other tools, including Hustle or Relay and social media, a plus. Experience managing a budget is a plus.
Cultural Competence : Demonstrated awareness of one’s own cultural identity, views about difference, and the ability to learn and build on varying cultural and community norms. Commitment to equity and inclusion as organizational practice and culture. Understands how environmental issues intersect with racism, economic and social inequality in the U.S. and has a passion for working to dismantle these systems.
Conditions : Ability to work hours exceeding stated office hours to get the job done, including weekends; ability and willingness to travel up to 25-30% as needed. Position requires a valid driver’s license. This position is based in Washington, DC. Please note that all LCV staff are currently working remotely during the COVID-19 pandemic.
To Apply : Send cover letter and resume to hr@lcv.org with “Deputy National Field Director” in the subject line by June 11, 2020. No phone calls please.
LCV is an Equal Opportunity Employer committed to a racially just, equitable and inclusive workplace.
Title: Deputy National Field Director
Department: Campaigns
Status: Exempt, short term 7-month position
Reports to: National Organizing Director
Positions Reporting to this Position: None
Location: Washington, DC
General Description :
LCV believes our earth is worth fighting for because everyone has a right to clean air, water, and a safe, healthy community. To ensure those rights are protected, we help people use their power to shape policy, hold politicians and polluters accountable, and influence elections.
Our over 2 million members, our volunteers and staff, and our more than 30 state affiliates (together, the Conservation Voter Movement) work for a more just and equitable democracy, where people—not polluters—determine our future. This movement is an influential national network with unparalleled influence in Washington, DC, in state capitals, and in communities around the country. We are unmatched in our ability to ensure meaningful action on our key issues. We aim to bring people and communities together across racial, geographic, political, religious, economic and other differences toward collective goals instead of dividing us from one another.
LCV is hiring a Deputy National Field Director, to support and oversee both non-electoral issue and independent expenditure electoral field programs. The Deputy National Field Director will support the National Organizing Director with the design and implementation of canvass programs. The position will collaborate with the Data and Analytics team to monitor program success and work with the broader team to achieve non-electoral and electoral goals. The position will also work closely with the Campaigns’ issue organizing team, supporting the execution of organizing efforts advocating for just and equitable climate policy. The Deputy National Field Director will work with state affiliate partners and coalition members on both issue and electoral efforts.
Responsibilities :
Work closely with national LCV staff and state LCVs to develop and oversee the implementation of all organizing programs for issue campaigns that engage community members and advocate for just and equitable federal environmental policy priorities.
Work with LCV staff and state LCVs to develop and oversee the implementation of field components of independent expenditure electoral campaigns, including potential vote by mail sign up, persuasion canvass or mobilization programs to increase turnout among youth and communities of color.
Develop and support implementation of remote and digital organizing tactics to educate and engage community members, with emphasis on these tactics in near term tactics to adapt to safer-at-home protocols.
Develop training and support materials for issue organizing programs to build necessary skills and abilities of program staff to engage racially diverse communities and explain intersection of policies and racial and environmental justice.
Help maintain relationships with coalition partners across the broader environmental, progressive, and electoral community and represent LCV’s interests at coalition meetings.
Work with the Campaigns’ Analytics and Data team to set and track all metrics related to organizing activities and progress in meeting goals.
Support creation of and manage review process for scripts and other field-related materials, ensuring that materials are culturally competent.
Ensure compliance and reporting of all field-related electoral activities working with the Legal and Finance departments.
Other duties as assigned.
Qualifications :
Work Experience : Required – 3-5 cycles or 4+ years experience in community, electoral, issue or labor organizing; 1 cycle or 2 years of experience managing and training teams representing a rich mix of talent, experience, backgrounds, and perspectives; Demonstrated experience tracking data in VAN or VoteBuilder. Demonstrated experience managing program staff remotely while building a strong team environment. Demonstrated experience implementing digital organizing tools, including peer-to-peer texting. Strongly Preferred - Experience working on an independent expenditure campaign. Preferred - Experience with youth organizing. Experience working with data models and scores; 1 cycle or 2 years of experience running paid canvass field programs.
Skills : Demonstrated ability to collaborate with colleagues and partner organizations. Demonstrated ability to represent organizational interests in coalitions. Ability to multitask without sacrificing quality of work. Ability to foster a collaborative team and results oriented work environment. Exceptional leadership, project management and coaching skills including supporting remote staff. Strong organizing skills, including a commitment to empowering activists and volunteers; creative and proactive in identifying and pursuing organizing opportunities. Must possess strong written and oral communication skills. Fluency in VAN and Microsoft Office Suite; other tools, including Hustle or Relay and social media, a plus. Experience managing a budget is a plus.
Cultural Competence : Demonstrated awareness of one’s own cultural identity, views about difference, and the ability to learn and build on varying cultural and community norms. Commitment to equity and inclusion as organizational practice and culture. Understands how environmental issues intersect with racism, economic and social inequality in the U.S. and has a passion for working to dismantle these systems.
Conditions : Ability to work hours exceeding stated office hours to get the job done, including weekends; ability and willingness to travel up to 25-30% as needed. Position requires a valid driver’s license. This position is based in Washington, DC. Please note that all LCV staff are currently working remotely during the COVID-19 pandemic.
To Apply : Send cover letter and resume to hr@lcv.org with “Deputy National Field Director” in the subject line by June 11, 2020. No phone calls please.
LCV is an Equal Opportunity Employer committed to a racially just, equitable and inclusive workplace.
League of Conservation Voters
Flexible
Title: Social Media Manager
Department: Membership and Online Engagement
Status: Exempt
Reports to: Senior Director of Digital Strategy
Positions Reporting to this Position: None
Location: Flexible
General Description :
LCV believes our earth is worth fighting for because everyone has a right to clean air, water, and a safe, healthy community. To ensure those rights are protected, we help people use their power to shape policy, hold politicians and polluters accountable, and influence elections.
Our over 2 million members, our volunteers and staff, and our more than 30 state affiliates (together, the Conservation Voter Movement) work for a more just and equitable democracy, where people—not polluters—determine our future. This movement is an influential national network with unparalleled influence in Washington, DC, in state capitals, and in communities around the country. We are unmatched in our ability to ensure meaningful action on our key issues. We aim to bring people and communities together across racial, geographic, political, religious, economic and other differences toward collective goals instead of dividing us from one another.
LCV is seeking a Social Media Manager to manage the organization’s Facebook , Twitter , and Instagram presence, with a focus on building and engaging LCV’s overall online community, leading digital rapid response, amplifying LCV’s messaging, and elevating LCV’s brand. The Social Media Manager will play an integral role in crafting LCV’s social media strategy, fine tuning its voice, and leading overall implementation. This role will also focus on mobilizing our audiences to take both online and offline action on pressing environmental issues, engaging members on local and national campaigns, and working to help elect pro-environment candidates. This is an excellent opportunity for a creative writer and social media expert who is passionate about politics to be a part of an innovative team that runs aggressive online campaigns to promote environmental policies and candidates.
Responsibilities :
Manage LCV’s social media accounts to engage and grow our online community, including day- to-day content creation that is culturally relevant. Write compelling, creative, engaging copy for all social media channels that amplifies LCV messaging with an emphasis on rapid response. Coordinate with other departments and LCV’s Chispa program to amplify LCV’s programs and ensure consistent messaging across the organization.
Focus on rapid response to help defeat LCV Victory Fund’s opponents as member of Independent Expenditure team. Support LCV’s organizational and programmatic priority goals on social media.
Monitor social discovery tools and stay attuned to current events and trending content in order to identify strategic engagement opportunities. Identify and share performance insights to inform the team’s engagement strategies. Identify creative campaign opportunities to mobilize LCV’s base and promote action on climate change, conservation, and environmental justice.
Work with the Senior Director of Digital Strategy to develop and implement a mid-tier influencer outreach strategy.
Manage fundraising efforts on social media including launching Facebook Fundraisers.
Help meet LCV’s ambitious social growth goals on Facebook, Twitter, and Instagram.
Analyze social media data and draw actionable insights, including regular audits, to inform our overall social media strategy.
Work with LCV’s graphic designer to create visually compelling and shareable graphics.
Participate actively in applying a racial justice lens to all LCV online communications with an increased emphasis on member education of issues, environmental or otherwise, where communities of color are disproportionately impacted.
Work with LCV’s state affiliates and other partner organizations to support local and statewide issue and electoral campaigns.
Perform other duties as assigned.
Qualifications :
Work Experience :
Required - 3-5 years of proven experience managing social media accounts and creating and curating content; experience elevating a brand on social platforms; experience on a political campaign or other experience in politics; proven experience growing social channels reach and influence; experience working in a fast-paced environment with an emphasis on rapid response; experience staying on top of news cycles.
Preferred - Advocacy and nonprofit experience; experience working in the climate movement; experience project managing teams.
Skills :
Required - Forward thinking, innovative, and creative mindset that is ready to push LCV forward through social media; excellent communicator, copywriter, and creative thinker, with an ability to use both data and intuition to inform decisions; effective working independently and ability to work in fast-paced environment; enthusiastic team player; passionate about the environment and advancing environmental justice.
Preferred - Experience with photography and/or videography; experience working with influencers; familiarity in Adobe CS programs (InDesign, Photoshop and Illustrator).
Cultural Competence : Shares our commitment to increasing racial diversity in our movement and organization, integrating justice and equity into the work we do and ensuring an inclusive organizational culture.
Conditions : Must be willing and able to work overtime, nights, and weekends as needed; ability and willingness to travel up to 10% for conferences. The location of this position is flexible. Please note that all LCV staff are currently working remotely during the COVID-19 pandemic.
To Apply : Send cover letter and resume to hr@lcv.org with “Social Media Manager” in the subject line by June 18, 2020. No phone calls please.
LCV is an Equal Opportunity Employer committed to a racially just, equitable and inclusive workplace.
Title: Social Media Manager
Department: Membership and Online Engagement
Status: Exempt
Reports to: Senior Director of Digital Strategy
Positions Reporting to this Position: None
Location: Flexible
General Description :
LCV believes our earth is worth fighting for because everyone has a right to clean air, water, and a safe, healthy community. To ensure those rights are protected, we help people use their power to shape policy, hold politicians and polluters accountable, and influence elections.
Our over 2 million members, our volunteers and staff, and our more than 30 state affiliates (together, the Conservation Voter Movement) work for a more just and equitable democracy, where people—not polluters—determine our future. This movement is an influential national network with unparalleled influence in Washington, DC, in state capitals, and in communities around the country. We are unmatched in our ability to ensure meaningful action on our key issues. We aim to bring people and communities together across racial, geographic, political, religious, economic and other differences toward collective goals instead of dividing us from one another.
LCV is seeking a Social Media Manager to manage the organization’s Facebook , Twitter , and Instagram presence, with a focus on building and engaging LCV’s overall online community, leading digital rapid response, amplifying LCV’s messaging, and elevating LCV’s brand. The Social Media Manager will play an integral role in crafting LCV’s social media strategy, fine tuning its voice, and leading overall implementation. This role will also focus on mobilizing our audiences to take both online and offline action on pressing environmental issues, engaging members on local and national campaigns, and working to help elect pro-environment candidates. This is an excellent opportunity for a creative writer and social media expert who is passionate about politics to be a part of an innovative team that runs aggressive online campaigns to promote environmental policies and candidates.
Responsibilities :
Manage LCV’s social media accounts to engage and grow our online community, including day- to-day content creation that is culturally relevant. Write compelling, creative, engaging copy for all social media channels that amplifies LCV messaging with an emphasis on rapid response. Coordinate with other departments and LCV’s Chispa program to amplify LCV’s programs and ensure consistent messaging across the organization.
Focus on rapid response to help defeat LCV Victory Fund’s opponents as member of Independent Expenditure team. Support LCV’s organizational and programmatic priority goals on social media.
Monitor social discovery tools and stay attuned to current events and trending content in order to identify strategic engagement opportunities. Identify and share performance insights to inform the team’s engagement strategies. Identify creative campaign opportunities to mobilize LCV’s base and promote action on climate change, conservation, and environmental justice.
Work with the Senior Director of Digital Strategy to develop and implement a mid-tier influencer outreach strategy.
Manage fundraising efforts on social media including launching Facebook Fundraisers.
Help meet LCV’s ambitious social growth goals on Facebook, Twitter, and Instagram.
Analyze social media data and draw actionable insights, including regular audits, to inform our overall social media strategy.
Work with LCV’s graphic designer to create visually compelling and shareable graphics.
Participate actively in applying a racial justice lens to all LCV online communications with an increased emphasis on member education of issues, environmental or otherwise, where communities of color are disproportionately impacted.
Work with LCV’s state affiliates and other partner organizations to support local and statewide issue and electoral campaigns.
Perform other duties as assigned.
Qualifications :
Work Experience :
Required - 3-5 years of proven experience managing social media accounts and creating and curating content; experience elevating a brand on social platforms; experience on a political campaign or other experience in politics; proven experience growing social channels reach and influence; experience working in a fast-paced environment with an emphasis on rapid response; experience staying on top of news cycles.
Preferred - Advocacy and nonprofit experience; experience working in the climate movement; experience project managing teams.
Skills :
Required - Forward thinking, innovative, and creative mindset that is ready to push LCV forward through social media; excellent communicator, copywriter, and creative thinker, with an ability to use both data and intuition to inform decisions; effective working independently and ability to work in fast-paced environment; enthusiastic team player; passionate about the environment and advancing environmental justice.
Preferred - Experience with photography and/or videography; experience working with influencers; familiarity in Adobe CS programs (InDesign, Photoshop and Illustrator).
Cultural Competence : Shares our commitment to increasing racial diversity in our movement and organization, integrating justice and equity into the work we do and ensuring an inclusive organizational culture.
Conditions : Must be willing and able to work overtime, nights, and weekends as needed; ability and willingness to travel up to 10% for conferences. The location of this position is flexible. Please note that all LCV staff are currently working remotely during the COVID-19 pandemic.
To Apply : Send cover letter and resume to hr@lcv.org with “Social Media Manager” in the subject line by June 18, 2020. No phone calls please.
LCV is an Equal Opportunity Employer committed to a racially just, equitable and inclusive workplace.
Mapp Biopharmaceutical, Inc.
San Diego, CA
Senior Director, Quality Assurance - GMP
Job #20-05A
Mapp Biopharmaceutical is an 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 advancement of the portfolio.
Partnering with the CMC, non-clinical, and clinical development functions at Mapp, the Senior 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:
Ph.D. (Doctor of Philosophy Degree) in Science with 10+ Years of Quality Assurance Experience (GMP required and additional GLP and GCP experience is an advantage) or an advanced degree with 15+ years with similar experience
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 QA and technical CMC experience with monoclonal antibody Drug Substance and/or Drug Product development, manufacturing, and/or commercialization
Previous technical CMC experience with monoclonal antibody Drug Substance and/or Drug Product development/commercialization
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:
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
Previous experience supporting Pre-approval Inspections is desirable
Experience working virtual preferred
Responsibilities
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 in the development of the Quality strategy for GMPs and ensures deployment as approved by senior management
Partners with Clinical to provide quality oversight for clinical Drug Product
Supports deployment and implementation of GxP practices, policies and procedures
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
Reports all critical and relevant Quality compliance matters to the Vice President of Quality Assurance
Ensures effective internal and external GxP audit programs are deployed and effective with focus on GMP manufacturing sites.
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
Assists in constructing annual GxP training
Authors Standard Operating Procedures (SOP's) related to GMP and other QMS related activities
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 ) 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
Acts as a SME on any GMP issue at the partner and clinical trial sites
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 enforcement of investigation of non-conformances, as well as fraud
Ensures where appropriate that all personnel training, investigation, deviation actions, critical documentation and audit actions at the manufacturing sites are completed on time
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 internationally and domestically approximately 25%. 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 l aw.
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/1412007-307440
Senior Director, Quality Assurance - GMP
Job #20-05A
Mapp Biopharmaceutical is an 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 advancement of the portfolio.
Partnering with the CMC, non-clinical, and clinical development functions at Mapp, the Senior 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:
Ph.D. (Doctor of Philosophy Degree) in Science with 10+ Years of Quality Assurance Experience (GMP required and additional GLP and GCP experience is an advantage) or an advanced degree with 15+ years with similar experience
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 QA and technical CMC experience with monoclonal antibody Drug Substance and/or Drug Product development, manufacturing, and/or commercialization
Previous technical CMC experience with monoclonal antibody Drug Substance and/or Drug Product development/commercialization
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:
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
Previous experience supporting Pre-approval Inspections is desirable
Experience working virtual preferred
Responsibilities
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 in the development of the Quality strategy for GMPs and ensures deployment as approved by senior management
Partners with Clinical to provide quality oversight for clinical Drug Product
Supports deployment and implementation of GxP practices, policies and procedures
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
Reports all critical and relevant Quality compliance matters to the Vice President of Quality Assurance
Ensures effective internal and external GxP audit programs are deployed and effective with focus on GMP manufacturing sites.
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
Assists in constructing annual GxP training
Authors Standard Operating Procedures (SOP's) related to GMP and other QMS related activities
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 ) 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
Acts as a SME on any GMP issue at the partner and clinical trial sites
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 enforcement of investigation of non-conformances, as well as fraud
Ensures where appropriate that all personnel training, investigation, deviation actions, critical documentation and audit actions at the manufacturing sites are completed on time
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 internationally and domestically approximately 25%. 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 l aw.
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/1412007-307440
