We are hiring a Principal Scientist, Vaccine Formulation & Process Development, an opening 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 vaccine portfolio in a dynamic and highly interdisciplinary environment to support pre-clinical and clinical development all the way up to commercialization. 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, antigen-adjuvant interaction understanding and characterization for formulation design, process development and scale up approaches and general pharmaceutical R&D is required.Responsibilities
The incumbent candidate will be responsible for conducting experiments in support of developing, evaluating and characterizing novel formulations/processes, components and supporting delivery technologies for diverse therapeutic modalities including (but not limited to) RNA-based therapeutics/vaccines, nanoparticle modality, mammalian and microbial fermentation derived candidate molecules, vaccines, plasmids, and peptides. 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, a 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.
- Support development of novel characterization techniques to characterize antigen-adjuvant interactions 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
- Investigate, develop and characterize vaccine therapeutics and prepare technical reports, communicate findings internally and externally, and present in cross-functional meetings
- 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.
- Contribute to scientific and strategy discussions to advance and enhance platforms and product candidates.
- 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.
- Experience in vaccine formulation and process development.
- Experience in defining dosage forms and driving projects in early and late stage development is desired.
- Experience with a variety of analytical techniques including UV, Fluorescence, HPLC, LCMS, CE, GC, NMR, KF, IR, DSC.
- Effective communication skills and the ability to write detailed technical reports.
- Solid foundation in Formulation, analytical, chemistry, material science, and antigen-adjuvant characterization.
- Experience with various biophysical and light scattering techniques (DLS, NTA, Coulter Counter, etc.).
- PhD with 4 or more years industrial experience in vaccine formulation and process development.
- Experience in a cGMP setting.
- Early and Late stage process development experience is preferred.
- Demonstrates ownership and can see things through (end-to-end).
- Sound understanding of when decisions should be made / elevated.
- Conceives and drives line initiatives, technology development and CMC strategy.
- Excellent interpersonal skills and ability to work with others in a dynamic and highly collaborative environment.
- 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.
Experience with vaccine formulation and process development in all stages of development
Additional Posting Information
- Good understanding of various vaccine antigens and adjuvant systems.
- Demonstrated ability to trouble-shoot antigen and adjuvant formulation, manufacturing processes and scale-up issues.
- Experience with biophysical characterization of vaccines.
- Eligible for Employee Referral Bonus
- Eligible for Relocation
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Research and Development