Pfizer Senior Principal Scientist/QC Lab Manager in Andover, Massachusetts
A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The qualified candidate will join the Analytical R&D organization and will contribute to the development of biological therapeutics. The candidate will be proficient in a breadth of analytical methodologies including HPLC, capillary electrophoresis, SDS-PAGE, DNA analysis, UV, ELISA, and understand various microbiological test methods (bioburden, endotoxin, organism identification). The candidate will be responsible for utilizing, troubleshooting and transferring analytical techniques to do release and stability testing for clinical compounds, as well as for supervising other scientists in these endeavors. In addition, the candidate is expected to work closely with customers and project timelines to prioritize samples, negotiate turnaround time, and provide data interpretation to. The candidate will be required to revise/review/author test methods, technical reports and lead investigations. The candidate may also serve on CMC teams, assuming responsibility for delivering the analytical strategy for protein, antibody, cell and gene therapies and vaccine drugs throughout the product development lifecycle.
The qualified candidate will join the Biotherapeutic Pharmaceutical Sciences Analytical R&D organization to supervise a QC Chemistry team that will help to enable development of biological therapeutics. The successful candidate will utilize, troubleshoot, transfer and schedule/oversee a wide variety of analytical techniques used in the release and stability assessment of large molecule clinical compounds The job involves direct supervision of other Analytical R&D colleagues. The candidate must excel at working in a collaborative, fast-paced environment with good attention to detail.
Education & ExperienceMINIMUM: B.S. in Chemistry, Biochemistry or equivalent with approximately 10-15 years' experience in a pharmaceutical industry laboratory setting utilizing a variety of techniques for the analysis/characterization of proteins, antibodies and/or vaccines. The candidate must have experience working in a GMP regulated environment and experience with supervising scientists and/or leading project teams.Technical Skills RequirementsMINIMUM: The candidate should have >10 years' experience in an industrial laboratory setting, with a working knowledge of the cGMPs. The candidate must have experience utilizing a wide variety of analytical techniques such as HPLC, CE, ELISA and qPCR. The candidate must have good interpersonal and collaborative skills, excellent communication skills (verbal and written), and be highly motivated with the desire to continuously learn and develop.DESIRED: We are seeking a highly motivated individual with solid scientific knowledge as well as extensive hands on laboratory experience with a variety of analytical techniques (HPLC, SDS-PAGE, CE, iCE, UV, ELISA, qPCR,). The successful candidate should have >10 years industrial experience using these techniques for analysis and/or characterization of biotherapeutics including; proteins, antibodies, vaccines, peptides, conjugates. An understanding of the drug development process is desired. The candidate should have a strong working knowledge of regulatory requirements, cGMP, FDA, EMEA and ICH guidelines. The candidate must be detail-oriented and have the ability to work effectively in a fast paced, multi-disciplinary team environment.OTHER ATTRIBUTES DESIRABLE:Excellent documentation skillsRelevant post-doc or industrial experienceExperience leading teams or technology initiativesAwareness of scientific literature*Experience with automation *Experience with database management *Experience with laboratory data systems such as LIMS and electronic notebooksPHYSICAL/MENTAL REQUIREMENTS Position requires occasional light lifting and periods of standing, sitting or walking.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Senior Principal Scientist/QC Lab Manager Andover, Massachusetts 1041526