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Group Leader, Formulation and Process Development

Pfizer


Location:
Saint Louis, MO
Date:
03/30/2017
Job Code:
1046953-1852
Pfizer
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Job Details

Job Title Group Leader, Formulation and Process Development

JobID 1046953-1852

Location: St. Louis, MO

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



*Role Description*

This position will be part of pharmaceutical research and development. The incumbent will be responsible for development of parenteral formulations, alternate drug delivery systems, and manufacturing processes (such as technology transfer and scale up) to enable the successful development of mammalian and microbial fermentation derived candidate molecules. As a senior principal scientist, this position will be part of formulation and process development leadership team and will be responsible for leading cutting edge projects and providing guidance to colleagues on product development. Senior principal scientist will be responsible for managing group of five to seven scientists across all levels.



*Responsibilities*

The Senior Principal Scientist, Biotherapeutics Pharmaceutical Research and Development is responsible for developing parenteral formulations, alternate drug delivery systems, and manufacturing processes (such as technology transfer and scale up) to enable the successful development of mammalian and microbial fermentation derived candidate molecules. The position will involve rapid, comprehensive, characterization of candidate molecules to determine the stability profile, and applying this information to develop an appropriate dosage form to meet clinical and commercial needs. The incumbent is responsible for developing/identifying new technologies and procedures to accelerate the biotherapeutic development process. The incumbent, working with Tech transfer group, is responsible for the development and scale-up of processes from bench top to pilot-scale and, as required, technology transfer to clinical or commercial plants. The Senior Principal Scientist, Biotherapeutics Pharmaceutical Research and Development must be able to interact effectively with a multi-disciplinary team of staff scientists for formulation optimization and overall candidate progression. Effective communication and personal leadership skills are desirable for interactions with laboratory scientists and associates, serving on multi-disciplinary project teams, and for project reviews with leadership team. The incumbent should be able to develop and mentor colleagues.



*Qualifications*

Educational BackgroundMinimum: 5 years with Ph.D. or Ten years with BS. of industrial or Post-Doc experience in parenteral formulation and process development of protein/peptide therapeutics. Demonstrated capability to perform independent research.Desirable: PhD in Biochemistry, Chemistry or equivalent with Post-Doc experience. Knowledge of drug development processes for progression of a biological candidate.Technical SkillsEssential:*Extensive knowledge of protein and/or vaccine and/or oligonucleotide and/or gene therapy based product development including analytical characterization and stabilization techniques*Experience in biotherapeutic parenteral formulation and process development of mammalian and microbial fermentation derived candidate molecules*Knowledge of drug development processes for progression of a biological candidate.*Demonstrated leadership skills (people and team leadership)*Ability to mentor and develop colleaguesDesirable: *Theoretical and practical knowledge of lyophilization and lyophilization cycle development is preferred. *Familiarity with parenteral manufacturing requirements, including media fills, environmental monitoring, container/closure integrity, and commercial unit operations. *Familiarity with GLP/GMP requirements.*Familiarity in scale-up and technology transfer to pilot/commercial scale.*Knowledge of protein drug delivery technologies*Experience with state-of-the-art analytical and bio-analytical methods *Excellent oral and written communication skills and ability to mentor junior staff and peers*Familiarity with Intellectual Property (IP) and IP strategy development*Experience in authoring regulatory submissions (IND, IMPD, BLA, MAA) *Understanding of biophysical attributes of biotherapeuticsNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS 5-10% Travel



*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.





*Group Leader, Formulation and Process Development*
*St. Louis, Missouri*
*1046953-1852*


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