Pfizer Principal Research Scientist in Pearl River, New York
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.
This is a Principal Scientist position within the Formulation Development group at Pfizer Vaccines Research. The key responsibility for this role is to contribute to the process and formulation development of next generation prophylactic and therapeutic vaccines leveraging novel antigen candidates and technology. This will involve managing a team to impact projects into early stages of clinical development.
The incumbent will lead the product development for proteins, polysaccharide conjugates, viral subunit vaccines and adjuvants in the Pfizer's Vaccine R &; D pipeline in Pearl River, NY. This will require managing a small research team. The key responsibilities will be:
• Interface with the purification group to design and execute screening studies to identify parameters affecting drug substance stability. The use of experimental design (DoE) and high throughput screening systems will be expected, as appropriate.
• Design and execute preformulation studies to identify stable drug product presentations that can be utilized in regulatory toxicology and clinical studies.
• Provide expertise and develop physicochemical and biophysical analytics to characterize formulations as appropriate, including DSC, FTIR, UV-Vis, DSC, DLS and protein spectroscopy.
• Provide expertise in development of Lyophilized drug product, scale up and cycle development.
• Provide expertise in drug product manufacturing process operations such as batch formulation, mixing, sterile filtration, aseptic fill/finish and dosage delivery systems.
• Oversee and manage drug product manufacturing process characterization and process development studies, as well as technology transfer for production of clinical trial materials. This will be performed under formal documented procedures and record keeping.
• Interpret data and draw final conclusions regarding progress and results of work. Present progress to senior management and project leadership. Write reports for internal communications as well as complete scientific papers for peered review journals. Present work at research internal seminars and external scientific meetings.
• • Manage a team to deliver the above, ensuring local compliance (and GLP/GMP when appropriate) is maintained throughout the development cycle of projects. Identify and facilitate collaborations with associated groups within Vaccines to best use Pfizer's broad knowledge base.
• Represent the Vaccine Formulation line on late stage project teams, being an effective conduit of information.
• Read scientific and technical literature in order to bring new and improved procedures to the laboratory, and to broaden understanding of disciplines outside area of training.
• Ph. D. in Pharmaceutical Sciences/Biochemistry with a minimum 4-6 years of postdoctoral experience, preferably in Biopharmaceuticals/Vaccine Industry, with significant experience in formulation of proteins, peptides, polysaccharide conjugates and viral vaccines with a focus on Process and Formulation Development.
• Experience in lyophilization production of biologicals.
• Strong verbal and written communication skills are required
• Experience of working with formulations and documentation practices that meet compliance expectations.
• Familiar with aseptic processing, and experience in technology transfer for parenteral drug product manufacturing.
• Experience with statistical analyses of data using SAS, JMP or Design expert
• Ability to lead formulation development and cross-functional development teams
• Exhibits exceptional professional maturity as exemplified by promoting interaction within and outside of group and a proven ability to train scientific staff in laboratory techniques.
• Experience in managing scientists is required
The candidate will design and execute lab experiments/studies, performs complex data analysis and authors technical development reports. Excellent verbal and written communication skills are required. Interaction and direct management of direct reports will occur.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
40 hours per week
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.
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.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 bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.