Principal Scientist, Pharmaceutical Research & Development

Role Summary

This scientific leadership role sits within Pfizer’s Biotherapeutics Pharmaceutical Sciences organization and is part of the Pharmaceutical Research & Development (PhRD) department. As Principal Scientist, you will lead formulation development and physio-chemical characterization efforts for Pfizer’s biotherapeutics portfolio (preclinical, clinical, commercial), which includes antibody-drug conjugates (ADCs), monoclonal antibodies, and proteins.

Success in this role demands exceptional time management, strong communication skills, meticulous attention to detail, and the ability to work in a cross-functional environment. A broad understanding of formulation design principles, analytical methodologies, biophysical characterization techniques, and process development is essential. The ideal candidate will contribute to regulatory documentation by generating source materials for formulation selection and characterization.

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‚Äôs 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.
• Maintain accountability for project success and results delivery.
• Communicate research and development findings internally and externally.

Required Qualifications

• 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, Biology or equivalent scientific field.
• Experience in formulation development, pharmaceutics, pharmacy or drug product manufacturing or scale-up of biotherapeutics modalities (such as proteins and antibody drug conjugates).
• Excellent leadership and/or mentorship skills.
• Experience with various biophysical and light scattering techniques (DLS, NTA, Coulter Counter, etc.).
• Experience with regulatory filings and submissions.
• 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.

Preferred Qualifications

• PhD with 4 or more years industrial experience in biotherapeutics formulation and process development.
• Expert understanding and leadership of technical areas necessary for biotherapeutic molecule formulation development.
• Solid foundation in formulation, analytical, chemistry, material science, and/or nano-particle technologies.
• Experience in scale-up and technology transfer of aseptic processes to pilot/commercial scale manufacturing facilities.
• 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.
• Ability to demonstrate autonomy in representing functional area.

Relocation support available

Work Location Assignment: On Premise