Job Description:
Our client is currently seeking an Associate Director/Director-level Analytical CMC Consultant to assist with CDMO management/oversight, analytical methods/techniques, document reviews, etc. The project will begin with getting acclimated with the internal teams & processes, get involved with scheduled CDMO meetings as documentation comes in, review documentation with Analytical Lead and transition into being the key analytical point of contact. Functions will involve review and troubleshooting of batch record releases, stability data, methods, protocols, analytical data, transfer processes to new manufacturing, and interacting with the Quality Group to assist with document reviews, deviations, and other related activities. Must work well independently, be a self-starter and show initiative in leading/driving project deliverables and deadlines. Excellent communication skills are required as there will be direct interface with 2-3 CDMO’s and cross-functional collaboration with internal/external contacts.
Skills required:
Previous AD/Director-level Analytical CMC experience within Biologics
CDMO Management/Oversight
GMP standards, CFR regulations, ICH guidelines, regulatory requirements for IND filings
Experience with analytical techniques such as: Cell based assays, SEC, CGE, R and R, iCIEf, CEX, Binding ELISA, Peptide mapping, Residual DNA, ProA, HCP sterility, endotoxin
Bonus/Nice to have:
Experience with mAb’s
Project management experience in maintaining timelines, following up on action items, etc.
Education:
Experience outweighs degree – MS or BS in Life Sciences field preferred but not mandatory
Remote: Analytical CMC Consultant (AD/Director-level) (232470)
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