Pfizer Scientist, Analytical R&D, Quality Control in Andover, Massachusetts
The qualified candidate will join the Analytical R&D QC organization to enable development of biological therapeutics in Andover, MA. The qualified candidate will be responsible for applying analytical methods in the assessment of product quality, biological activity, detection of impurities and characterization. This group performs testing in the R&D and/or regulated settings in support of clinical drug candidates. The group also supports method development, transfer, verification, qualification and validation as well as troubleshooting.
The qualified colleague is responsible for troubleshooting and utilizing analytical methodologies to support GMP release and stability testing of clinical supplies. The individual is responsible for becoming proficient in a breadth of analytical methodologies including Compendial test methods, HPLC, electrophoresis, PCR, and ELISA. The colleague must work within corporate guidelines and appropriately record, archive and report all data. The colleague may also represent the laboratory in activities related to regulatory queries and inspections. The colleague will also be required to train other colleagues on analytical procedures and laboratory operations, conduct laboratory related investigations, lead deviations and CAPAs.
Bachelor's Degree with 3-6 years of experience or Master's Degree with 2-4 years of experience with a degree in chemistry, analytical chemistry, biochemistry, biology or related field
Minimum of three years (one years with MS) of working with Quality Systems within a GMP environment.
The colleague must be able to interact effectively with peers and leaders as part of a multi-disciplinary team across multiple geographies.
The colleague must thrive in a fast-paced environment.
Attention to detail, strong organizational skills, the ability to multitask and effective interpersonal, influencing skills and communication skills are required.
Experience with development of vaccines, gene therapy, MAbs and other large molecule products.
Experience with the development, qualification, validation and troubleshooting of PCR, DLS and/or LC-MS methods.
Experience with method development over a wide variety of large molecule technologies.
Ability to follow established procedures under minimal supervision.
Experience in analysis of large molecules.
Experience with laboratory data systems such as Empower, and Laboratory Information Management Systems
Some knowledge of drug development process for progression of biological colleagues.
A strong familiarity with 21 CFR Part 210 and 211, ICH and Compendia guidelines (USP, EP, JP) within the frame work of QC biological testing is preferred.
Experience leading laboratory investigations, deviations and CAPAs in a regulated environment is desirable. As well as, regulatory experience and work within the operations of GMP environment is desirable.
Other Job Details:
Last Date to Apply: May 31, 2020
Eligible for Employee Referral Bonus: Yes
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Research and Development