Principal Scientist, Pharmaceutical Research & Development Full-time

Principal Scientist Biotherapeutics

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 physico-chemical characterization efforts for Pfizer's biotherapeutics portfolio, which includes antibody-drug conjugates (ADCs), nucleic acid delivery systems, monoclonal antibodies, antibody constructs, proteins, and vaccines.

Initially focused on supporting the ADC portfolio, this role requires working in a dynamic, interdisciplinary environment to advance preclinical, clinical, and commercial development programs. You will be responsible for scale-up and technology transfer activities, ensuring robust and scalable formulation strategies that meet regulatory and manufacturing requirements.

The ideal candidate will contribute to regulatory documentation by generating source materials for formulation selection and characterization. Success in this role demands exceptional time management, strong communication skills, and meticulous attention to detail. A broad understanding of analytical methodologies, biophysical characterization techniques, and formulation design principles is essential, along with experience in process development and drug delivery technologies.

Responsibilities include:

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

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, Virology, Biology or equivalent scientific field.
• 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.
• 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.
• Experience in designing parenteral dosage forms for biotherapeutics modalities including protein based, conjugates, vaccines or nanoparticle delivery systems.
• Experience in antibody drug conjugate development
• Excellent leadership skills.
• Experience in scale-up and technology transfer of aseptic processes to pilot/commercial scale manufacturing facilities.
• Solid understanding of thermodynamics and kinetics.
• 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.