Pfizer Senior Principal Scientist, Formulation in St. Louis, Missouri
This position will be part of Pharmaceutical Research and Development. The candidate will lead the drug product development, scale-up and transfer of parenteral formulations and manufacturing processes for various biologics modalities such as gene therapies, monoclonal antibodies, antibody drug conjugates, proteins and vaccines. This is a project and people leadership-based position performing formulation and drug product process development activities for biotherapeutic molecules from pre-clinical and Ph I clinical trials through manufacturing process performance qualification, license application and commercialization.
The S enior Principal Scientist Group Lead, Biotherapeutics Pharmaceutical Research and Development will be responsible for the performance and development of 6-8 colleagues within the group. The candidate will be a member of the leadership team and help influence the formulation and process development strategies across the portfolio.
The S enior Principal Scientist Group Lead, Biotherapeutics Pharmaceutical Research and Development is responsible for developing parenteral formulations, alternate drug delivery systems, and tech transfer manufacturing processes to enable the successful development of biotherapeutic drug products including gene therapies , prophylactic and therapeutic vaccines and protein-based modalities. The position will involve leading a technical project team that will apply characterization and stability information to develop an appropriate dosage form to meet clinical and commercial needs. The position is responsible for leading the formulation and development activities from pre-clinical and Ph I clinical trials through commercialization.
The candidate is responsible for developing/identifying new technologies and procedures to accelerate the biotherapeutic development process across projects.
PhD., M.S. with 5 or more years industrial experience, or Bachelor's/Master's Degree with 10 or more years of industrial experience in Pharmacy, Pharmaceutics, Biomedical Eng, Chemical Eng, Biochemistry, Biotechnology, Virology, Biology or equivalent scientific field.
Experience in formulation development, pharmaceutics, pharmacy or drug product manufacturing or scale-up of biotherapeutics modalities
Experience in biotherapeutic parenteral drug product formulation or process development of protein or gene therapy or vaccines.
PhD., M.S. with 8 or more years industrial experience, or B.S. with 13 or more years of industrial experience in biotherapeutic formulation development and scale up.
Experience in leading teams associated with formulation development, pharmaceutics, pharmacy, drug product manufacturing, and scale-up of gene therapy modalities through regulatory filing and commercial launch.
Experience in leading multidisciplinary technical teams.
Experience in responsibility for performance and development of direct reports.
Working knowledge of regulatory filing process.
Ability to manage and develop a high-performing group composed of engaged and effective colleagues who are coached, developed, mentored and provided with on-the-job experiences to learn new skills necessary for career advancement.
Excellent oral and written communication skills.
Experience in leading and developing direct reports and peers across matrix teams.
Excellent leadership skills
Expert understanding and leadership of technical area necessary for biotherapeutic molecule formulation development.
Experience in scale-up and technology transfer of aseptic processes to pilot/commercial scale manufacturing facilities.
Solid understanding of thermodynamics and kinetics.
Working knowledge of GLP/GMP requirements Experience in authoring regulatory submissions (IND, IMPD, BLA, MAA).
Experience in application of QbD concept in design, execution, and interpretation of formulation and process development experiments
Demonstrates ownership and can see things through (end-to-end).
Sound understanding of when decisions should be made / elevated.
Conceives and drives line initiatives, technology development and CMC strategy.
Serves as a mentor and demonstrates ability to serve as a role model.
Influences lines outside of Pharmaceutical Research and Development - can devise and explain strategy, concepts and complex technology to experts and non-experts alike.
Builds effective relationships with cross-functional Pfizer customers (e.g., listening skills, demonstrates empathy, conflict resolution).
Benchmarks and stays current with external publications, conferences or meetings.
Scientific contributions recognized outside of Pharmaceutical Research and Development; increased external influence (e.g,. publication, consortium, regulatory influence).
Other Job Details:
Last Date to Apply for Job: November 27, 2020
Eligible for Relocation Package: YES
Eligible for Employee Referral Bonus: YES
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Research and Development