Pfizer is looking to solve the problem of developing and commercializing biotherapeutics, including antibody-drug conjugates, nucleic acid delivery systems, monoclonal antibodies, and vaccines, by hiring a Principal Scientist to lead formulation development and physico-chemical characterization efforts.
Requirements
- Solid foundation in formulation, analytical, chemistry, material science, and/or nano-particle technologies.
- Experience in formulation development, pharmaceutics, pharmacy or drug product manufacturing or scale-up of biotherapeutics modalities.
- Experience with various biophysical and light scattering techniques (DLS, NTA, Coulter Counter, etc.).
- Experience with regulatory filings and submissions.
- Working knowledge of GLP/GMP requirements.
- Experience in authoring regulatory submissions (IND, IMPD, BLA, MAA).
- Solid understanding of QbD concept in design, execution, and interpretation of formulation and process development experiments.
Responsibilities
- Design, execute, and analyze experiments for existing and novel modalities. Define the appropriate parenteral dosage form, formulation, process design, scale up approaches, identify critical parameters, and define the design space
- Support development of novel characterization techniques to characterize formulations to support process development and formulation design.
- Lead experiments to confirm robust process performance across the control space. Compile experimental and analytical results, perform data interpretation, summarize, and report on data with conclusions and recommended next steps
- Provide technical representation and subject matter expertise (SME) in cross functional project teams
- Provides leadership and mentorship to matrixed program team colleagues
- Collect and share relevant academic literature, leverage external consultants/SMEs, and establish new collaborations with internal groups. Optimize current processes to ensure robust manufacturing of Pfizer’s biotherapeutic portfolio
- Interface extensively in a matrixed environment with process and analytical development teams for process investigation support, assess new analytical technologies, support on-going process characterization and post-approval changes.
Other
- Master of Science degree with 9 or more years of industrial experience; or B.S. with 12 or more years of industrial experience in Pharmacy, Pharmaceutics, Analytical Chemistry, Biophysics, Biomedical Eng, Chemical Eng, Biochemistry, Biotechnology, Virology, Biology or equivalent scientific field.
- Effective communication skills and the ability to write detailed technical reports.
- Exceptional organizational, communication, and critical thinking skills, and the ability to thrive in an interdependent and idea-rich environment.
- Strong work ethic and attention to detail.
- Relocation support available.
