Contract Manager / Sr Manager CMC Quality Control (QC)
Our client is currently seeking an experienced professional to join their CMC Operations team as a contract Quality Control (QC) 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 early phase pre-clinical / clinical programs for all gene coding/therapy modalities.
Responsibilities:
The Contract Manager / Senior Manager - CMC QC will:
- Support the external contract organization activities to fulfill the GMP QC testing needs
- Provide internal support to CMC Operations to support the development, manufacture, and material release, including method transfer/qualification/validation and product shelf life.
- Collaborate with PDAS, Manufacturing, CROs in performing seamless technical transfer of testing methods and assays, troubleshooting.
- 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
- 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 CMC Ops, QA and other departments to address review comments on QC/analytical documents
- Manage/assist the document creation and review via the eQMS (e.g. ZenQMS)
- 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 the eQMS
- Perform other duties, as needed
Qualifications:
- Bachelor's Degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related Life Science field with 5-8 yrs experience within the biotech/pharma industries
- 3+ years of Analytical / Quality Control experience in a GMP environment
- 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
Job Type: Full-time
Pay: $115,000.00 - $120,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
Work Location: In person