Group Leader- Drug Product Design & Development (DPDD), is a position within the Pharmaceutical Research & Development (PhRD) department in Pfizer's Biotherapeutics Pharmaceutical Sciences (BTxPS) organization. This individual will be expected to provide strong technical, strategic and organizational leadership to ensure efficient and timely execution of group deliverables. The position will focus on design and development of parenteral drug products for biologics modalities such as monoclonal antibodies, proteins, vaccines, oligonucleotides, viral vectors for genomic therapeutics, and novel modalities such as nanoparticles and liposomes from pre-clinical through commercial stages of development.
- The Group Lead role is responsible for planning and developing a staff of 5 to 8 scientists, identifying growth opportunities and mentoring so that all staff can realize their full potential, as well as dealing with performance issues appropriately.
- This colleague will be expected to provide strong technical, strategic and organizational leadership, effectively manage a multi-project development portfolio and make strong technical and strategic contributions to multi-disciplinary/ cross-functional development project teams to ensure efficient and timely execution of DPDD/PhRD deliverables
- Performance of all duties associated with the operation of effective research laboratories is expected, including mentorship of laboratory scientists.
- The Group Leader will be responsible for identifying and implementing operational efficiency improvements.
- Provides visible, passionate and optimistic organizational/technical/personal leadership and actively fosters colleague engagement, models and engenders desired values and behaviors, including quality, integrity, respect, collaboration and personal accountability.
- Successful development, characterization, and execution of state-of-the-art drug product formulations and processes- An accomplished leader who applies extensive scientific and technical experience and business acumen to establish strategies, drive safe and high-quality lab work and deliver well-controlled and characterized formulations and processes.
- Has the ability and mastery (technical and interpersonal skills, awareness of functional area deliverables and business/ Regulatory context) to train & mentor colleagues in specific lab techniques or processes.
- Establishes and drives relevant and impactful innovation programs to enhance formulation/process development /manufacturing /characterization technologies and work-processes.
- Ensures that innovation strategy is aligned with broader business drivers and current and emerging Regulatory paradigms.
- Contributes to Project, Technical and Strategic Teams as appropriate; reaches across organizational, functional and geographic boundaries to provide appropriate context and communication (in both directions) to ensure effective technical and strategic integration at all internal and external interfaces outside the department as appropriate.
- Ph.D. degree in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Biochemistry, or equivalent with 4+ years, OR Master's degree with 8+ years of postgraduate experience in biotech/ biopharma industry with a focus on formulation and process development of biologics drug products.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Has demonstrated supervision/leadership of high caliber scientists and ability to mentor junior staff and peers.
- 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.
- Expert knowledge and relevant work experience in biologics related to formulation & process development and drug delivery, scale-up/manufacturing and/or technology transfer.
- Extensive knowledge of overall drug development with experience developing commercially relevant formulations and processes.
- Experience with managing multiple projects in parallel, including key participation on multi-disciplinary project teams
- Demonstrated ability to drive for results and lead innovation and change.
- The successful candidate will possess strong oral and written communication skills.
- Strong analytical and computer skills are also required.
- Good knowledge of GLP/GMP and experience contributing to CMC regulatory documents is needed.
Other Job Details:
- Work related travel to other Pfizer sites and collaborators/contract organizations is expected to take 10 - 15% of the time.
- Eligible for Relocation Package: YES
- Eligible for Employee Referral Bonus: YES
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Research and Development