Senior Scientist, Analytical R&D

ROLE SUMMARY

The qualified candidate will join the Analytical R&D 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/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 working in a breadth of analytical methodologies including HPLC and CE and applying these methods to a broad range of biotherapeutics. 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.

ROLE RESPONSIBILITIES

• 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).

BASIC QUALIFICATIONS:

• Ph.D. (0-3 yrs) or MS (>5 yrs) in analytical chemistry or related field.
• Experience with interdisciplinary drug development teams and industrial experience developing chromatographic and electrophoretic assays to assess the quality and characteristics of biotherapeutic drug candidates.
• Experience working in a regulated environment (e.g. GLP, cGMP).
• 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.

PREFERRED QUALIFICATIONS:

• 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 or CE for analysis and/or characterization of biologicals including; proteins, antibodies, oligonucleotides and/or vaccines.
• Experience setting and implementing analytical comparability strategies for glycoprotein therapeutics and/or vaccines.
• ICH method validation experience is valued.
• Direct experience authoring and reviewing regulatory documents and working with FDA or European regulatory authorities.
• Understanding of emerging high-throughput technology platforms and applications to sample preparation and analysis.
• Experience with state-of-the-art protein characterization and analysis techniques, including mass spectrometry, NMR and biophysical characterization.
• Experience in lipid and/or surfactant analysis.
• Experience with protein expression and purification.
• Experience with method development and qualification.
• Knowledge of organic chemistry and conjugation reactions.

Other Job Details:

• Last Date to Apply for Job: February 25, 2021
• Eligible for Employee Referral Bonus: YES

PHYSICAL/MENTAL REQUIREMENTS

• Position requires occasional light lifting and periods of standing, sitting or walking.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• None

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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.

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