Principal Scientist - Formulation and Process Development
Location:
Saint Louis, Missouri
Posted:
August 03, 2016
Position Type:
Full Time
Category:
Research
Reference:
1036062


About the company
A career at the company offers opportunity, ownership and impact.

All over the world, the company 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. the company, 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.

Responsibilities
The 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 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.

Qualifications
Educational Background
Minimum:
4 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 Skills
Essential:
• Extensive knowledge of protein and/or vaccine and/or oligonucleotide chemistry, degradation pathways, 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

Desirable:
• 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 is preferred
• 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
• Demonstrated leadership skills
• Familiarity with Intellectual Property (IP) and IP strategy development
• Experience in authoring regulatory submissions (IND, IMPD, BLA, MAA)
• Understanding of biophysical attributes of biotherapeutics
• Experience in vaccines formulation and process development
• Ability to mentor and develop colleagues

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:
5-10% Travel

Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.

EEO & Employment Eligibility
the company 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. the company 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. the company is an E-Verify employer.
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