Principal Scientist, Formulation Development
Posted on Apr 5, 2021 by Pfizer
Principal Scientist- Formulation Development, is a position within the Pharmaceutical Research & Development (PhRD) department in Pfizer's Biotherapeutics Pharmaceutical Sciences organization. This scientific leadership role will be responsible for formulation development, investigating physico-chemical characterization methods, scale up and tech transfer of Pfizer's biotherapeutics portfolio which include various modalities such as gene therapy, nucleic acid delivery, monoclonal antibodies and antibody construct, proteins and vaccines. Candidate will be expected to work in a dynamic and highly interdisciplinary environment to support pre-clinical, clinical and commercial development. In addition, the candidate should be able to contribute formulation selection and characterization source documentation to support regulatory submissions. This position requires exceptional time management and communications skills with a strong attention to detail. A breadth of knowledge of analytical tools and techniques applied to materials science, colloidal structure and stability, process development and tech transfer approaches, nanotechnologies for formulation design, nucleic acid drug delivery and general pharmaceutical R&D is required.
The incumbent candidate will be responsible for conducting experiments in support of developing, evaluating and characterizing formulations/processes, components and supporting delivery technologies for diverse therapeutic modalities including (but not limited to) mammalian and microbial fermentation derived candidate molecules, vaccines, plasmids, RNA-based medicines, peptides, and targeted delivery strategies. This individual function cooperatively with other members of the team to achieve the project goals. The incumbent displays technical awareness in various aspects of drug discovery and development, leads technical project team/s that will apply characterization and stability information to develop an appropriate dosage form to meet clinical and commercial needs, strong drive in learning new techniques and scientific commitment, and impactful scientific and technical contributions within the PhRD team and the respective project teams. Specific 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 formulation, process and analytical investigations for commercial production processes.
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.
M.S. with 8 or more years of industrial experience, or B.S. with 10 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.
PhD with 4 or more years industrial experience in biotherapeutics formulation and process development.
Expert understanding and leadership of technical area necessary for biotherapeutic molecule formulation development.
Experience in designing parenteral dosage forms for biotherapeutics modalities including protein based, gene therapy, vaccines or nanoparticle delivery systems.
Experience in nucleic acid drug development (DNA, RNA, oligonucleotides).
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
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