Principal Scientist- Particle Characterization, 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 subvisible and visible particle characterization and forensic investigations of particles in drug product supporting Pfizer's biotherapeutics portfolio. The position lies in a dynamic and highly interdisciplinary environment to support pre-clinical, clinical, and commercial development. In addition, the candidate should be able to contribute to the development of particle characterization strategy both analytically and to support regulatory submissions. This position requires exceptional time management and communications skills with strong attention to detail. A breadth of knowledge of analytical tools and techniques as it relates to particle characterization for both visible and subvisible particle characterization in the pharmaceutical industry is required. Responsibilities
The incumbent candidate will be responsible for defining strategy for particle characterization in biotherapeutic products, performing critical 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 functions 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: Role Responsibilities
- Design, execute and analyze experiments for particle characterization of existing and novel modalities.
- Define the appropriate parenteral dosage form, formulation, process design, scale-up approaches, identify critical parameters, and define the design space
- Development of novel characterization techniques to characterize both visible and subvisible particles to support process development and formulation design.
- Develop and be abreast of new technologies to aid in forensic assessment of particles
- 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 the process and analytical development teams for process investigation support, assess new analytical technologies, support ongoing process characterization and post-approval changes.
- Maintain accountability for project success and results delivery.
- Communicate research and development findings internally and externally.
Minimum : M.S. with 8 or more years of industrial experience, or B.S. with 10 or more years in Pharmacy, Chemistry, Biomedical Eng, Chemical Eng, Biochemistry, Biotechnology, material science or equivalent scientific field,
Ph.D. with 4 or more years industrial experience in Pharmaceutical Sciences, Analytical Chemistry, Biophysics, Biomedical Eng, Chemical Eng, Biochemistry, Biotechnology, Material science or equivalent scientific field preferably in particle characterization, biotherapeutic formulation development and scale-up Requirements
- Solid foundation in particle characterization technologies (i.e. microscopy, FTIR, light obscuration, flow imaging)
- Effective communication skills and the ability to write detailed technical reports
- Experience with regulatory filings and submissions.
- A strong interest and motivation to learn new technologies and concepts is expected
- 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
- Expert understanding and leadership of technical area necessary for biotherapeutic particle characterization
Additional Posting Information
- Excellent leadership skills
- 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 the functional area.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
- Last Date to Apply for Job: October 25 , 2021
- Eligible for Employee Referral Bonus
- Eligible for Relocation Package
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Research and Development