A Cell Culture Group Leader position is available within the Gene Therapy Process Development group in Bioprocess R&D. The successful applicant will be responsible for developing innovative, robust, efficient, and scalable cell culture processes and technologies required for the advancement of Pfizer's growing gene therapy program. They will be expected to provide strong technical, strategic, and organizational leadership so as to ensure efficient and timely execution of group deliverables. The position will focus on process design, unit operation scale-up and scale-down and apply rigorous scientific and engineering principles and approaches to all aspects of cell culture process development.
The Group Leader will work closely with other leaders in the group to develop new technologies and deliver the project portfolio. This position supports project management and other Bioprocess R&D functions to facilitate the timely delivery of processes and pre-clinical/clinical supplies of AAV vectors; supports transfers to pilot facilities to meet supply objectives for clinical materials, ensures that scalable processes are developed that are ready for process validation and commercialization.
The Group Leader (Senior Principal Scientist) role is responsible for planning and developing a staff of 4-8 scientists and engineers, identifying growth opportunities and mentoring so that all staff can realize their full potentials, as well as dealing with performance issues appropriately. Performance of all duties associated with the operation of effective research laboratories is expected, including mentorship of laboratory scientists. This position will be expected to prepare internally reviewed technical reports, contribute to regulatory filings, make oral presentations to scientists and management, and publish externally. The Group Leader will be responsible for identifying and implementing operational efficiency improvements. The successful candidate must be capable of implementing change to business infrastructure to ensure pipeline, legacy and technology success.ROLE RESPONSIBILITIES
- Responsible for successful development, characterization and execution of state-of-the-art cell culture manufacturing processes- accomplished technical leader who applies extensive scientific and technical experience and business acumen to establish strategies, drive safe and high-quality lab technical work and deliver well-controlled and characterized manufacturing processes.
- Provides creative and pragmatic technical and operational problem-solving options.
- Demonstrated supervision / leadership of high caliber engineers and scientists; ability to mentor junior staff and peers
- Experience in supporting the scale-up and technology transfer to pilot / commercial scale.
- Extensive knowledge of drug development (with a particular strength in the area of cell culture process technologies).
- Demonstrated experience with managing multiple development projects in parallel, including key participation on multi-disciplinary project teams.
- Good knowledge of GLP/GMP and Biotechnology CMC regulatory requirements.
- Familiarity with process development utilizing quality risk management and quality by design concepts.
- Excellent oral and written communication skills.
- Ph.D. degree in Chemical/Biochemical Engineering, Biochemistry, or equivalent with 8+ years of experience or Masters degree with 15+ years of experience
- The candidate should have demonstrated technical expertise in developing cell culture processes.
- Experience contributing to regulatory submissions including IND, BLA, and MAA is required.
- Demonstrated leadership success in both project and people management. This position requires highly motivated individuals with the ability to work closely with other members of the laboratory and the department in a matrix team environment to also drive novel innovative technology strategies.
- Demonstrated ability to drive for results and lead innovation and change.
- Collaborative, team oriented leadership and management style essential.
- Applicants should be bright, organized, self-motivated, and capable of working independently, and in a collaborative environment.
- The successful candidate will possess strong oral and written communication skills. Strong analytical and computer skills are required.
- Over 8-15 years relevant work experience in Chemical/Biochemical Engineering, Biochemistry, or equivalent, including process development, process scale-up, technology transfer, and support for process validation and commercial production, within the Biopharmaceutical industry.
- 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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Ability to perform mathematical calculations and ability to perform complex data analysis
- Travel to other Pfizer sites (Chesterfield, MO, Morrisville, NC, and Andover, MA, and others) and to support process technology transfers to contract manufacturing organizations in US and rest of the world as appropriate.
- Relocation eligible
- Eligible for employee referral bonus
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Research and Development