The Director/Associate Director of Quality Control will oversee all aspects of QC testing for Ocugen’s portfolio of therapeutics including AAV gene therapy, biologics and vaccines. He/she will provide subject matter expertise in the QC testing of raw and in-process materials, drug substance and finished products for all modalities covering the full range of analytical methodologies (e.g., Chemistry, bioassay, microbiology etc). This individual will also support the implementation and management of systems meant to control the lifecycle of analytical methods from development through qualification and monitoring. This position reports directly to the Senior Director, Quality.
Duties and Responsibilities
- Develop, implement, and maintain policies, procedures, and material control systems to ensure GMP compliance while managing costs and driving efficiencies.
- Partner with Analytical Development to ensure methods are properly developed, qualified, and installed at Contract Laboratory, ensure all aspects of the lifecycle are appropriately documented.
- Confirm that all Ocugen methods are reliable throughout the lifecycle through method monitoring, trending and proactive management.
- Support resolution of suspect result laboratory investigations and support QA in the assessment of OOS results.
- Verify that Contract Laboratories have appropriate Data Integrity related controls.
- Supports availability of materials in the supply chain, as scheduled, and the maintenance of inventory at minimum acceptable levels in partnership with Supply Planning.
- Responsible for validating quality of raw materials, in process goods and finished product, as well coordinating quality oversite of global procurement efforts
- May assist with the establishment and maintenance of the production control system.
- Participate in monitoring audits of internal and external production and quality control areas.
- Assist as required internally and externally regarding quality interpretation of Regulatory requirements
- Lead and support various QA, QC, and cross-functional activities/projects, as needed
- Provide guidance and assist in qualification activities as needed.
- B.S., M.S. or PhD with focus in Chemistry or Life Sciences field
- 8+ (B.S.), OR 6+ (M.S.), OR 4+ (PhD) years of relevant and current work experience in pharmaceutical or biotech quality role required
- Vaccines and /or Biologic and gene therapy QC experience required.
- Expert knowledge of analytical services in the pharma or biotech industry.
- Solid and demonstrable knowledge of GMP and GLP and GCP international regulations related to analytical testing.
- Proven background in audit management, risk management, mitigation and controls
- Strong organization, problem solving and time management skills
- Attention to detail with an ability to perform critical review of various types of documents
- Outstanding communication skills and demonstrated ability to work independently and effectively as a team member with multidisciplinary project teams.