This group is responsible for all analytical aspects of drug product development spanning all phases of development from pre-Phase I through registration and technology transfer to Pfizer Global Supply. This includes both non-GMP and GMP work in support of Solid Oral Drug Products and involves development and validation of analytical methods, specifications and control strategies, deep degradation and stability understanding, dissolution expertise and a rudimentary understanding of structural characterization of drug product impurities. This is a new group and will consist of up to 40 colleagues spanning all levels of the scientific career ladder (R1-R8) and Director level career ladder.ROLE RESPONSIBILITIES: Accountable for the following....
- Ensure all laboratory operations (training, equipment, data generation, documentation, and review) are in accordance with appropriate safety and quality procedures and best practices.
- All aspects of drug product analytical method development to support formulation development, packaging determination, clinical supply testing, commercial testing, and successful regulatory filings.
- Structural Elucidation and characterization of Drug Product impurities
- Development of product specifications based on safety and efficacy and manufacturing performance
- Collaborate on overall biopharmaceutics strategy and responsible for meaningful dissolution method development, validation and specifications
- Analytical method transfer to PGS and external vendors, as needed
- Analytical sections of regulatory filings (CTDs, INDs etc)
- Understanding of product degradation chemistry, prediction of rates of degradation, and overall ensuring a robust scientific package to support a viable product shelf life and storage conditions.
- Define strategic direction for the group and influence overall global ARD strategy as a member of the ARD Leadership Team.
- Identification, development, and adoption of new technologies to ensure discipline excellence and industry leading capability and value.
- Influence internally and externally as an industry leader in the Analytical Science discipline
- Develop and execute plans for identifying/procuring or developing key technical skills in the group for current and future needs through active workforce planning.
- Responsibility for training and establishing effective technical mentoring arrangements to grow that innovative product development expertise in this new group.
- Ensuring an engaged workforce built around a culture of equity, transparency, integrity, innovation and scientific excellence.
- Building and maintaining excellent partnerships with leaders of key partners including Drug Product Development, Drug Product Supply, GCMC, PGS, Chemical R&D, and Medicinal Chemistry
- PhD +10 years or BSc/MSc + 15 years of experience or equivalent in Analytical Chemistry or related Pharmaceutical Science discipline with significant knowledge of pharmaceutical development.
- Significant expertise in analytical chemistry and its application towards pharmaceutical development
- Knowledge of GMP as it relates to laboratory operations
- Demonstrated ability in development of colleagues
- Outstanding collaborative skills
- Regulatory filing experience
- Well versed on ICH and other regulatory guidance with understanding of impact on analytical development
- Knowledge of Pharmaceutical Sciences and overall product development
- Extensive analytical research and development experience in innovative drug product development including but not limited to
- Knowledge of in vitro dissolution method development and validation
- Knowledge of the development of appropriate in vitro/in vivo relationships (IVIVC or IVIVR) using a variety of scientific tools and methodologies (e.g. simulations, modeling).
- Regulatory expectations around bioequivalence of dosage forms and "clinical safe space"
- Regulatory expectations around nitrosamines and TiO2
- Chromatographic and stability modeling tools
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. PHYSICAL/MENTAL REQUIREMENTS
No special requirements.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This position will require occasional travel to other Pharm Sci Small Molecule sites in the US and UK with travel estimated around 10% of time.ADDITIONAL JOB INFORMATION
- Last Date to Apply: May 24, 2022
- Relocation support available
- Eligible for employee referral bonus
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Research and Development