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:

• Monday to Friday

Work Location: In person