Pfizer Sr. Associate Scientist, Bioassay & Impurity Testing in St. Louis, Missouri
The Bioassay and Impurity Testing Group in Chesterfield MO is seeking candidates to join us in building capabilities to lead the industry in the advancement of novel products to the market through innovation and execution of analytical testing. The qualified candidate will contribute primarily to the development of vaccines, as well as to gene therapies (e.g., adeno-associated virus) and monoclonal antibodies, with emphasis on a range of immunoassays and cell-based bioassays. Working within a team setting, the qualified candidate will be responsible for developing analytical methods 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, including vaccines, gene therapy, antibody-drug conjugates, therapeutic proteins and monoclonal antibodies. The candidate will work across analytical functions and projects and will also provide technical counsel to other organizations and senior leadership.
Responsible for performing and troubleshooting immunoassays and cell-based assays, while applying these methods to a broad range of biotherapeutics for early and late stage products in a GMP environment.
Documenting and reporting lab work according to GMP practices
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 and technical reports
Bachelor's Degree with 2-5 years of experience or Master's Degree with 0-2 years of experience developing and performing immunoassays (e.g., Nephelometry, ELISA, MSD, and flow cytometry) and cell-based assays (e,g, infectivity, cytotoxicity, expression) for biotherapeutic drug candidates.
Proven record of delivering results in a fast paced environment and effective communication to project teams.
Demonstrated technical writing skills and good interpersonal skills a must.
Track record of people and team leadership/collaboration skills as leaders of small project activities/teams.
Previous experience developing immunoassays, particularly nephelometry based.
Experience in vaccines, immunology, virology, or related-field.
Experience in GxP (GLP, GMP) environment, with LIMS, and implementation of continuous improvement practices.
Method validation experience.
Comfortable and effective in a team-based, fast-paced environment where multi-tasking required
Comfortable giving presentations in small group meetings
Verbal and written communication skills
Detail orientation and high degree of organization
Experience with immunoassays, particularly development and/or troubleshooting
Other Job Details:
Eligible for Employee Referral Bonus: Yes
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Research and Development