Principal Scientist, Gene Therapy Purification Development
Posted on Apr 5, 2021 by Pfizer
The Gene Therapy Process Development group of Pfizer's Bioprocess R&D organization in Morrisville, NC is seeking a highly motivated and energetic Principal Scientist to lead development efforts at the forefront of purification process development to support Pfizer's growing pipeline. The successful applicant will be responsible for the development of early and late stage purification processes, tech transfer, innovation projects, process characterization, and authoring of associated regulatory submissions. She/he will be expected to provide strong technical and strategic leadership and make significant contributions to cross-functional project teams to ensure efficient and timely execution of the team's deliverables.
Responsible for successful development, characterization and tech transfer of state-of-the-art manufacturing processes for AAV purification.
Technical leader who applies scientific and technical expertise and business acumen to establish strategies, drive safe and efficient lab work, and deliver robust, high-quality, and high-yield manufacturing processes.
Develops creative and pragmatic solutions to technical and operational challenges.
Performance of all duties associated with the operation of effective research laboratories is expected, including mentorship of laboratory scientists.
Contributes to regulatory submissions and query responses; presents data/strategy to peers and management in appropriate internal and external venues (technical meetings, project team meetings, conferences); authors technical reports, patent applications, and publications in peer-reviewed journals, as appropriate.
Establishes and drives relevant and impactful innovation programs that are aligned with business drivers and regulatory paradigms to enhance upstream manufacturing technologies and work processes.
Demonstrates positive leadership qualities, mentors junior scientists, and fosters a collaborative team environment; models and engenders desired values and behaviors, including quality, integrity, respect, and personal accountability.
PhD degree with 4+ years of experience, Masters degree with 9+ years of experience, or Bachelors degree with 12+ years of experience in Chemical/Biochemical Engineering or Life Sciences related field, with relevant industry experience in purification process development.
Experience with successful process development, tech transfer and process scale-up to GMP manufacturing is required.
Experience with chromatographic and membrane based separations is required.
Strong oral and written communication skills as well as analytical and computer proficiencies.
Demonstrated ability to drive for results and lead innovation and change.
Applicants should be organized, self-motivated, and capable of working both independently and collaboratively; adept at working in a fast-paced team environment with shifting priorities.
Expertise in at least one of the following areas is preferred: chromatographic separation, filtration (nominal and ultrafiltration/diafiltration), and tech transfer.
Proficient in statistical experimental design and analysis of complex multi-variate processes.
Ability to perform mathematical calculations and ability to perform complex data analysis.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional travel required for company meetings and technology transfer activities to manufacturing facilities (