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CMC Analytical Consultant


This is a Full-time position in South San Francisco, CA posted March 27, 2021.

nn This position will support analytical development, qualification and QC related activities of a monoclonal antibody at the contract manufacturing for Drug Substance and Drug product.

In this role you will provide guidance on the large molecule analytical development, validation and establishment of specifications, while supporting project management activities.

These activities will include; validation of analytical methods at CMOs for drug substance and drug product manufacturing, perform data review and the investigation of the analytical testing/validation issues while supporting the Quality & Regulatory Affairs teams in preparing CMC section in regulatory filings.

nn n n Job Requirements: n A degree Biochemistry, Chemistry, Chemical engineering or related discipline.

PhD with minimum 5 years of experience, MS with 10 years, BS with 15 years In-depth experience and knowledge in large molecule analytics Excellent project management skills Broad knowledge of the biopharmaceutical industry, including in-depth operating knowledge of the processes and functions involved in biologics drug development and comparability assessment Experience in recombinant protein submissions Must have excellent problem-solving skills and verbal and written communication skills Requires working knowledge of IND/BLA submissions, Quality and regulatory requirements Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues Comfortable executing on multiple projects independently

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