USA - MO - St Louis
ApplyApply with LinkedIn
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 Bioassay and Impurity Testing Group is seeking a candidate to join in building capabilities to lead the bio-pharmaceutical industry in the advancement of novel products to the market through innovation and execution of analytical testing. The qualified candidate will contribute to development of vaccines, as well as monoclonal antibodies, recombinant proteins, antibody drug conjugates, and related biologic therapeutics. Working within a team setting, the qualified candidate will be responsible for developing and maintaining analytical methods focused on cell-based bioassays and immunoassays to monitor the intended mechanism of action of drug candidates and to confirm residual host impurities are controlled. This data is required to elucidate structure-function and to confirm suitable quality of clinical supplies in a broad biologics portfolio. The candidate will work across analytical functions and projects and will also provide technical counsel to other organizations and senior leadership.
• Development, qualification, validation, and transfer of cell-based and immunoassays in support of diverse portfolio in varying stages of clinical development.
• Adherence to GMP practices in execution and documentation.
• The candidate must be able to interact effectively with multi-disciplinary project teams.
• The candidate is expected to tabulate data, provide data interpretation to their teams and to their customers.
• Revise/review/author test methods, technical reports and regulatory content.
• Mentor other colleagues on scientific and strategic directions.
• Ph.D. with 0-3 years of experience, M.S. with 5-10 years of experience, or B.S. /B.A. with 10+ years of experience in immunology, cell biology, virology or closely-related field.
• Experience developing and performing cell-based assays (e.g., cytotoxicity) and immunoassays (e.g., rate nephelometry, Bioplex/Luminex, ELISA, MSD, or flow cytometry) for biotherapeutic drug candidates, particularly vaccines.
• Proven record of delivering results in a fast-paced environment and effective communication to project teams.
• Excellent technical writing and verbal presentation skills.
• Outstanding leader behaviors and the ability to collaborate and mentor others is a must.
• Experience in GxP (GLP, GMP) environment, method qualification and ICH method validation is desirable.
Position requires occasional light lifting and periods of standing, sitting or walking.