Role of analytical SME for proteincharacterization of complexbiologic material (i.e.,Protein Separation, HPLC, MS, Raman, Fluorescence)
Manage the development of analytical methodsand subsequent validations (ie enzyme activity methods, molecular assays, potency assays) .
Oversee quality controland stability testingof the product at ContractTesting Laboratories (CTLs) and/or Contract Manufacturing Organizations (CMOs).
Provide content and author for sections relatedto analytical methods,product specifications, and product stability in biologics regulatory submissions.
Coordinate analytical methodstransfers to and between CMOs and CTLs.
Contribute (as analytical SME) to investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results.
Work collaboratively with manufacturing/supply chain,quality assurance and CMC project management to ensure timely availability of lot release and stability data and to ensure adequate planning for stability supplies.
Support formulation development of dosage forms.
Support creation/execution of in-vitro dissolution packages for purposesof formulation bridging during clinical development and in support of commercial lifecycle management.
M.S. or Ph.D. degree in Chemistry, Biochemistry, Analytical Chemistry, or a relatedfield.
Minimum 5+ years relevant experience in analytical development and/or quality controlin biological setting
Extensive experience with analytical characterization of biologics, as well as development of qualitative/quantitative methods for release testing is required.
Analytical development experience developing, qualifying, validating, and transfer of chromatographic methods (e.g., HPLC, UPLC, GC, CE), spectroscopic methods (e.g., UV, FTIR, Raman,Fluorescence, CD), immunochemical, and other physicaland biochemical methodsto analyze biologic or protein drug substances and drug products is required.
Demonstrated experience with development, qualification, and validation of microbiology methods, ELISA or other immunoassays for potency, identityanalysis (e.g., HPLC, LC-MS) for drug substance or product release is preferred.
Demonstrated experience with development, qualification, and validation of tests for identity, purity,potency for API and drug product (raw materials, in-process, release) and/or excipients is required.
Experience managing/working with quality controlrelease/stability testing programs
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