This Job Vacancy has Expired!

Senior Scientist, Formulation Development

Posted on Apr 5, 2021 by Pfizer

Chesterfield, MO 63005
Research
Immediate Start
Annual Salary
Full-Time


As a Senior Scientist, you will be at the center of our operations and you'll find that everything we do, every day, is in line with an unwavering commitment to quality. This colleague will be part of the Pharmaceutical Research and Development team. In this role, you will lead the 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-based position performing formulation and process development activities for biotherapeutic molecules from pre-clinical and Ph I clinical trials through manufacturing process performance qualification, license application and commercialization.


It is your dedication that will make Pfizer ready to achieve new milestones and help patients across the globe


How You Will Achieve It


The Senior Scientist 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


Lead a technical project team inside and outside the lab that will apply characterization and stability information to develop an appropriate dosage form to meet clinical and commercial needs


Lead the formulation and development activities from pre-clinical and Ph I clinical trials through commercialization


Executing new technologies and procedures to accelerate the biotherapeutic development process across projects


Qualifications


Must-Have


BS in Degree in in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry, Bioengineering, Biotechnology, Biology, Biomedical engineering and 9+ years of industry or equivalent experience


MS degree in the disciplines above and 7+ or PhD and 1+ years of industry or equivalent experience


Nice-to-Have


Demonstrated industry experience in parenteral formulation and process development of biotherapeutic


Demonstrated 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 as well as QbD concept in design, execution, and interpretation of formulation and process development experiments


Working knowledge of GLP/GMP requirements


Experience in authoring regulatory submissions (IND, IMPD, BLA, MAA)


Ability to demonstrate autonomy in representing functional area




Reference: 1152695245

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