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Hope College Holland, MI, USA
Feb 18, 2018
Full time
The Hope College Psychology Department invites applications for a Visiting Assistant Professor in Developmental Psychology for the 2018-19 academic year. Candidates will be expected to teach introductory psychology, lifespan developmental psychology, and possibly a seminar in one's specialty. The Psychology Department has 13 faculty, graduates 75-80 majors per year, and has research facilities to support candidates who wish to engage in research. Applicants must have completed (or nearly completed) a PhD, a commitment to undergraduate education, and some evidence of teaching undergraduates.
Mapp Biopharmaceutical, Inc. San Diego, CA, USA
Feb 16, 2018
Full time
Senior Advisor Job #12-17A   Mapp Biopharmaceutical is a small biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of diseases, such as neglected and tropical infectious diseases. The Senior Advisor is responsible for leading and managing multi-expression platform process development and contract manufacturing organization (CMO) activities in the Mapp Biopharmaceutical Biologics Bulk Drug Substance area. The BioProcessing Senior Advisor will support the design, development, characterization and validation of Drug Substance manufacturing and control processes for the Mapp Biopharmaceutical monoclonal antibody programs pre-Candidate Selection through to Commercialization.  This person will work closely with a cross-functional virtual team and CMOs.  Responsibilities include the development and optimization of downstream purification processes, including scale-up/Tech Transfer to GMP manufacturing. The successful candidate is expected to work independently on assigned tasks/projects and to prioritize assignments to meet timeline targets.   Basic Qualifications: D. in a relevant discipline such as Chemical Engineering, Biomedical Engineering, Biochemistry, Molecular Biology, or related discipline Minimally 15 years experience or M.S. and 20 years equivalent and years of relevant industrial experience in DSP process development and internal or external GMP manufacturing and process validation of therapeutic biologics drug substance including recombinant protein, fragment antibody, monoclonal antibodies Minimum 15+ years (for BS) or 10+ years (for MS) experience in biomolecule downstream process development and/or GMP manufacturing Familiar with laboratory to large-scale chromatography equipment and Tangential Flow Filtration (TFF) operations Experience with analytical methods used for downstream process development Experience with Upstream activities is an asset Experience leading a group of scientists and engineers with diverse technical and educational levels, manage development activities for plant or mammalian production and be accountable for timelines, progress and deliverables from the development phase to regulatory filing for commercialization Experience leading platform expression systems that could include plant, microbial or mammalian-derived downstream purification process development and optimization, scale up, technology transfer, process validation, process mapping and characterization and manufacturing activities at small scale at internal or CMO laboratory and Phase 1-3 clinical scale or commercial scale at 1st Party, 2nd Party or 3rd Party/CMO sites Established track record of sustained performance and deliverables for development and GMP manufacturing of plant or mammalian processes at internal or external clinical/commercial manufacturing sites in a small, mid to large Pharmaceutical / Biotechnology industry Experience having executed tech transfer and GMP production for Phase 1-3 clinical and/or commercial manufacturing at CMOs for mammalian-derived biotechnology derived drug substance Experience in process development and GMP manufacturing of recombinant proteins, FAb, and mAb Experience in Process Modeling, COGs analysis, Process Improvement Lean Six Sigma, Production Planning/Scheduling and demonstrated use of DOE, QbD and FMEA are a plus In-depth knowledge and hands-on biotechnology industry experience in development and manufacturing and process validation of plant or mammalian processes Knowledge of the applicable global regulations, cGMP, ICH, and Quality Systems including Change Control, Investigations, and Deviations Strong leadership, prioritization, quick decision-making, people management skills Ability to work independently as well as within multi-disciplinary project teams Outstanding written/verbal communication and presentation skills are essential Ability to manage multiple projects in a dynamic team environment which require creativity, innovation and thinking outside the box Detail oriented with proven organization, prioritization and collaboration skills Ability to cultivate excellent cross-functional collaborations, effectively communicate at multiple levels of the organization Ability to influence colleagues and leaders in various departments Customer focused, passion to succeed and promote team work with high integrity Knowledge of downstream process development for biologicals, including but not limited to product recovery, purification, and formulation development Experience with downstream process development, at both the bench and pilot scales, using a wide range of purification techniques (including recovery, clarification, and chromatography of all types, precipitation, UF/DF, formulation, etc) and analytical methods (HPLC, SDS-PAGE, IEF, Western blot, assay for Endotoxin (LAL), Host cell proteins evaluation, UV/Vis Spectrophotometry, BCA and Bradford protein concentration assays) Experience in providing on-site technical oversight and troubleshooting during manufacturing operations at pilot and/or commercial scale Experience with technology transfer and process scale-up for clinical and commercial manufacture desired Experience in a cGMP environment Experience with process study protocol development, execution, data analysis and final report completion Experience in the preparation of a process data package for BLA submission is an asset  Task & team-oriented, analytical, organized, detail-oriented, self-motivated & ability to multitask Excellent record keeping abilities to adequately document process development data   Preferred Qualifications: Process/chemical engineering background is desirable   Responsibilities Provides leadership and develops/mentors staff internally or at CMO through effective coaching and development Leads and oversees clinical manufacturing for therapeutic biologics in Development Responsible for plant or mammalian process development, mapping, characterization, scale-up and manufacturing oversight at contract sites, process mapping and characterization from early to late-stage process development and manufacturing up to regulatory submissions and technical support during commercial manufacturing phase Conducts and/or oversees laboratory studies to define downstream purification process parameters for scale up, tech transfer and GMP manufacture of process consistency and Phase 1 to 3 drug substance batches in adherence to technical excellence, corporate goals, project timelines, global regulations and quality compliance Leads the development strategy for plant-based and/or mammalian production Accountable for timelines, progress, and deliverables from the development phase to regulatory filing for commercialization Provides technical input and expertise to cross-functional project teams, prepare written and oral presentations, authors/reviews/approves protocols/reports and collaborates/interacts with internal customers including other functions within Biologics Development as well as Project Management, Research, Legal, Regulatory, Quality, Manufacturing and CMOs Works closely with CMO technical teams to develop scalable downstream processes for product recovery, clarification, purification, and formulation of monoclonal antibody bulk Drug Substance molecules Supports process scale up for cGMP manufacturing; reviews production batch records for GMP manufacturing, supports and troubleshoots cGMP production activities Reviews protocols, procedures, data analyses, and reports for process development, characterization and robustness studies Provides on-site oversight before, during, and after manufacturing operations at the CMO, as needed Provides support for the statistically sound study design and study data analysis Partners closely with analytical chemists, other process chemists, quality, regulatory and project management Reviews CMO study protocols, data, and reports and deviation documentation for scientific soundness and accuracy Authors and reviews internal reports, memos, summary documents, and contributes to regulatory submission documents Performs statistical analysis on process data as necessary using programs such as JMP (or equivalent) Participates in the establishment of process control strategies Ensures proper documentation and reporting of experiments and results Other duties as assigned   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 opportunitiy to work remotely. Mapp wants you to join their team and invites you to apply.   No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.   Equal Opportunity 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/j/671986-186114
PeopleTec, Inc. Huntsville, AL, USA
Feb 16, 2018
Full time
PeopleTec, Inc. is currently seeking a  Lethality Engineer  to   support our Huntsville, AL location. Primary duties include assisting a multi-dimensional team with the development of modeling approach and algorithms predictive of material response in high speed impact and penetration / damage events. The selected individual will perform modeling and simulation development and analysis of medium-fidelity, fast-running, physics-based mathematical models. Models include extensive ray-tracing through complex three-dimensional geometries, iterative calculations and complex interfaces with external tools. Efforts will be performed at our corporate office with extensive interaction with combined Government and contractor teams. The candidate will support and participate in program reviews, briefings, workshops and working groups. Strong verbal and written communication skills are required.   Required Skills/Experience: At least 2 years of demonstrated software development, modeling and simulation experience Software development experience in C/C++ Experience with the Visual Studio development environment. Experience with Microsoft Office applications Excellent organizational and analytical skills Excellent oral and written communication skills  Travel : 5% Must be a U.S. Citizen Candidate must be able to pass a Federal Background Investigation and receive a Security clearance. Although not required at hire, the inability to receive a positive investigation adjudication will result in dismissal.   Education Requirements: A completed Bachelor's Degree in Engineering (Mechanical or Aerospace), Computer Science, Mathematics or Physics from an accredited university and 2+ years of experience is required.  (Engineering degree is preferred.)   Desired Skills : 3D coordinate transformation and visualization function experience is desired   EOE/Minorities/Females/Veterans/Disabled PeopleTec, Inc. is an Equal Employment Opportunity employer and provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in its job application procedures. If you have any difficulty using our online system and you need an accommodation due to a disability, you may use the following email address,  HR@peopletec.com  and/or phone number (256.319.3800) to contact us about your interest in employment with PeopleTec, Inc. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, citizenship, ancestry, marital status, protected veteran status, disability status or any other status protected by federal, state, or local law. PeopleTec, Inc. participates in E-Verify. 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/731357-145621
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