Pfizer Scientist in Andover, Massachusetts
Bioassay and Impurity Testing Group: We are 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. Working within a team setting, the qualified candidate will be responsible for the development, maintenance and testing of critical reagents and assays to evaluate process-related impurities in biological candidates in clinical development.
The qualified candidate will have a thorough understanding and knowledge of the development of immunoassays and/or PCR assays. The methods may be used for release testing and product characterization to ensure residual host impurities are controlled. These data are required to confirm suitable quality of clinical supplies in a broad biologics portfolio, including vaccines, gene therapy, antibody-drug conjugates, therapeutic proteins and monoclonal antibodies.
Prior experience in assay validation is highly desirable, as well as any experience working in cGMP environment. Excellent writing skills and the ability to document and communicate results to a wide array of scientists and management will be critical. Ability to multitask while working with multiple people in a team-based environment is a requirement.
Responsible for development, troubleshooting, qualification and testing of qPCR-based assays and immunoassays. and their associated critical reagents 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 in biology, biochemistry, immunology, biotechnology or related field with 7-10 years of experience developing and performing qPCR-based assays and immunoassays (e.g. ELISA) 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.
Experience with automation platforms (e.g. Hamilton, TECAN, Caliper, etc.).
Previous experience developing assays.
Experience in GxP (GLP, GMP) environment and implementation of continuous improvement practices.
Method validation experience.
Other Job Details:
Last Date to Apply for Job: May 22, 2020
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Research and Development