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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