Sr. Principal Scientist ? Purification Process Development,
Sr. Principal Scientist ? Purification Process Development,
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All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
A Senior 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.
He/She 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 Senior 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 Senior Principal Scientist is responsible for planning and developing a staff of 3-5 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.
The Senior 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, ensures that scalable processes are developed that are ready for process validation and commercialization.
The Senior 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. The Senior Principal Scientist will be responsible for identifying and implementing operational efficiency improvements.
EDUCATIONAL BACKGROUND: Ph.D. degree in Chemical/Biochemical Engineering, Biochemistry, or equivalent with 8+ years of experience or Masters degree with 15+ years of experience.
REQUIRED EXPERIENCE/SKILLS: 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. 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 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.
•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.
•Experience developing commercially relevant process 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.
Equal Employment Opportunity
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.
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