The qualified candidate will join the Analytical R&D organization to enable development of biological therapeutics in Chesterfield, MO. 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, DNA using qPCR, and ELISA. The colleague must work within corporate guidelines and appropriately record, archive and report all data. The colleague may also represent the laboratory during 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.
BS (MS preferred) 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.
Experience with development of vaccines, gene therapy, MABs and other large molecule products.
Experience with method development over a wide variety of large molecule technologies.
Some knowledge of drug development process for progression of biological candidates.
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.
The colleague must be able to interact effectively with peers and leaders as part of a multi-disciplinary team across multiple geographies. The candidate 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.
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.
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EEO & Employment Eligibility
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Other Job Details:
Last Date to Apply for Job: March 28, 2019
Eligible for Relocation Package: no
N (Other) (United States of America)
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