Senior Scientist – Lyophilization Process & Formulation Development
Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.
ROLE SUMMARYThis position will be part of the Biotherapeutics Pharmaceutical Research and Development group located in Chesterfield, MO (St. Louis area). The candidate will serve as a subject matter expert in lyophilization process and formulation design and optimization. As part of this role, they will lead the development, scale-up and transfer of lyophilized parenteral formulations and manufacturing processes from pre-clinical studies through to commercialization. Leadership responsibilities may include personnel supervision, project management, and/or oversight of laboratory activities. The candidate should be active in advancing the science and engineering of lyophilization and alternative drying technologies.
- Develop lyophilization (freeze-drying) processes and lyophilized formulations for biotherapeutics
- Scale-up from the laboratory to full-scale cGMP production
- Utilize product characterization techniques and stability information to develop an appropriate dosage form to meet clinical and commercial needs.
- Mentor and train other colleagues
- Pursue innovations in lyophilization, formulation, and alternative drying technologies
- Participate in management of the laboratory including safety, efficient operation and coordination of equipment purchasing and maintenance
- Influences other groups within the company – 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.
- B.S. in Chemical or Biochemical Engineering, Pharmaceutical Sciences or a related field, and 8+ years industry or equivalent experience.
- M.S. in Chemical or Biochemical Engineering, Pharmaceutical Sciences or a related field, and 6+ years industry or equivalent experience.
- Ph.D. in Chemical or Biochemical Engineering, Pharmaceutical Sciences or a related field.
- Familiar with lyophilized product characterization methods including differential scanning calorimetry, freeze-drying microscopy, moisture measurement, crystallinity characterization, dynamic vapor sorption and surface area measurement.
- Excellent leadership skills
- Expert understanding and leadership of lyophilization process and formulation development for biotherapeutics.
- Experience in scale-up and technology transfer of aseptic manufacturing processes, including lyophilization, to pilot/commercial scale manufacturing facilities
- Solid understanding of thermodynamics and kinetics
- Working knowledge of cGMP requirements.
- Experience in authoring regulatory submissions (IND, IMPD, BLA, MAA)
- Solid understanding of QbD concept in design, execution, and interpretation of formulation and process development experiments.
- Ability to demonstrate autonomy in representing functional area.
- Communicates well in written form and verbally across functional areas and large groups.
- Solid understand of heat and mass transfer principles
- Mathematical modeling experience
- Understanding of cGMP manufacturing of sterile injectable products
Other Job Details:
- Last Date to Apply for Job: November 1, 2021
- Eligible for Employee Referral Bonus: YES
- Eligible for Relocation Assistance: YES
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