A Principal Scientist position is available within the Purification Process Development (PPD) group in Bioprocess R&D. The successful applicant will be responsible for developing innovative, robust, efficient, and scalable purification processes and technologies required for the advancement of a diverse and extensive portfolio of large molecules including proteins and vaccines. 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 purification process development.ROLE RESPONSIBILITIES:
The candidate 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 and cross-functional project teams to ensure efficient and timely completion of PPD deliverables.
The Principal scientist has the ability and mastery (technical and inter-personal skills, awareness of functional area deliverables, and business/Regulatory context) to train/mentor more junior colleagues.
The Principal Scientist will work closely with other leaders in the PPD 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 for proteins and vaccines derived from mammalian and microbial expression; supports transfers to pilot facilities to meet supply objectives for clinical materials, and ensures that scalable processes are developed that are ready for process validation and commercialization.
The Principal Scientist will be expected to establish and drive relevant and impactful innovation programs to enhance PPD technologies and work processes and ensure that the innovation strategy is aligned with broader business goals and emerging regulatory paradigms. 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.QUALIFICATIONS:
- Ph.D. degree in Chemical / Biochemical Engineering, Biochemistry, or equivalent with 5+ years of experience or BS / MS with 10+ years of experience.
- Over 10 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.
- The candidate should have demonstrated technical expertise in developing chromatographic and membrane based separation processes.
- Experience contributing to regulatory submissions including IND, BLA, and MAA and demonstrated leadership success in project progression is required.
- 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. Collaborative, team oriented leadership and management style essential.
- Demonstrated ability to drive for results and lead innovation and change. Applicants should be bright, organized, self-motivated, and capable of working independently and in a collaborative environment.
- Applicants should also have strong oral and written communication as well as analytical and computer proficiencies.
- Experience in supporting the scale-up and technology transfer to pilot / commercial manufacturing scale.
- Experience developing commercially relevant processes for products derived from mammalian and microbial processes.
- Experience with chromatographic and membrane based separations.
- Experience with all aspects of membrane filtration, viral clearance and filtration.
- Extensive knowledge of drug development (with a particular strength in the area of purification 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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Work will be performed in a typical development laboratory environment and in GLP/GMP manufacturing facilities including the operations areas of pilot plants.
Other Job Details:
- Occasional weekend work and possible travel to support development projects.
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
- Eligible for Relocation Assistance: YES
- Eligible for Employee Referral Bonus: YES
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Research and Development