Pfizer Senior Scientist, Analytical R&D in St. Louis, Missouri
The qualified candidate will join the Analytical R&D (ARD) organization to enable development of biotherapeutics in Chesterfield, MO. Within Analytical R&D, the candidate will join the Project Progression & Biochemistry Group focused on monoclonal antibodies, oligonucleotides, vaccines, and other biological modalities. This group develops analytical methodologies and strategies needed to progress biotherapeutic products in the pipeline; this includes method development, process support, formulation and stability support, product characterization, method qualification, method validation and method transfer. The candidate will be involved in the development and implementation of a mass spectrometry-based Multi-Attribute Method (MAM). Our MAM team uses this methodology and strategy to progress biotherapeutic products in the pipeline, provide process and formulation support, and conduct product characterization. The candidate must have strong skills in protein-based HPLC separations and mass spectrometry characterization. The candidate must be able to interact effectively with multi-disciplinary project teams. In addition, the candidate is expected to provide data interpretation for their teams and customers, and revise/review/author test methods, technical reports, and regulatory filings. The above skills will be applied to a large platform of projects in all stages of development.
Why Patients Need You
Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.
Technical Leader: provide technical leadership in the characterization of biotherapeutics.
Project Leadership: potentially serve as an ARD Project Lead and lead Analytical sub teams across ARD.
Coach and mentor junior colleagues.
Responsible for building key analytical strategies and the development, validation, and transfer of assays for release and characterization of biotherapeutics.
Writing and reviewing technical reports, SOPs, validation reports, and regulatory documents (e.g., INDs, BLAs and queries).
Ph.D. (0-3 yrs) or MS (>7 yrs) in analytical chemistry, biochemistry, or related field.
Experience with interdisciplinary biotherapeutic drug development teams and industrial experience developing chromatographic and electrophoretic assays to assess the quality and characteristics of biotherapeutic drug candidates.
Proven record of delivering results in a fast-paced environment and effective communication to project teams and external partners (e.g. regulatory authorities).
Demonstrated technical writing skills.
Outstanding leader behaviors and the ability to collaborate with and mentor others is a must.
Post-doctoral experience in developing /troubleshooting analytical methods for biotherapeutics.
The ideal candidate will have experience developing and using the following techniques: all modes of HPLC and MS for analysis and/or characterization of biologicals including; proteins, antibodies, peptides, and conjugates.
Understanding of emerging high-throughput technology platforms and applications to automate sample preparation and data analysis.
Experience setting and implementing analytical comparability strategies for glycoprotein therapeutics and/or vaccines.
Direct experience authoring and reviewing regulatory documents and working with FDA or European regulatory authorities.
Experience in sample preparation automation and data analysis.
Experience with method development and qualification.
Position requires occasional light lifting and periods of standing, sitting or walking.
Additional Posting Information
Last Date to Apply for Job: June 21, 2021
Eligible for Employee Referral Bonus
Eligible for Relocation Package
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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.
Research and Development