Manager/Senior Manager, CMC Quality Control

4 weeks ago

California, United States Tandym Group Full time

A recognized biopharmaceutical company in California is currently seeking an experienced professional to join their CMC Quality Control Department as their new Manager or Senor Manager. In this role, the Manager / Senior Manager will be responsible for all aspects of the CMC QC program(s) support for the company's commercial and clinical programs, including all modalities and all molecules.

***This is a Hybrid opportunity requiring 2 days onsite in Brisbane, CA and 3 days remote work.*** ***W2 Only***

Responsibilities: The Manager / Senior Manager - CMC Quality Control will: Support the external contract organization activities to fulfill the GMP QC testing needs Provide internal support to QC operations to support the development, manufacture, and release of Biologics, small molecule, and oligonucleotide products Ensure that all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agencies Support the development and validation of analytical methods used for QC testing of small molecule and oligonucleotide products Implement and maintain quality systems to ensure the integrity and reliability of QC data Manage, review, and organize Release/stability data from active stability programs and generate interim stability trending assessments and reports Work within QC and with QA and other departments to address review comments on QC/analytical documents Manage/assist the document creations and reviews via Veeva Document System Create and update batch analysis tables for stability data Keep track of contract lab stability time point pulls for different programs Create Excel/JMP tables and graphs for stability data trending Initiate and manage change controls, deviations and CAPA in Veeva Document System Perform other duties, as needed

Qualifications: 3+ years of Analytical / Quality Control experience in a GMP environment Bachelor's Degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related Life Science field Previous experience in the Biotech and/or Pharmaceutical industry Good understanding of cGMPs, ICH stability, and Regulatory Drug requirements Microsoft Office proficient (Excel, Word, etc.) Great interpersonal skills Excellent communication skills (written and verbal) Strong attention to detail Highly organized Desired Skills: Working experience and knowledge in a wide variety of Quality Control Stability methodologies Experience in conducting Stability Studies per ICH Guidelines Proficient in Statistical Analysis software

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