Quality Control Supervisor - Emeryville, United States - Planet Pharma

Description

A clinical-stage cell therapy company in the Bay Area is looking to add a Senior Manager of Quality Control to their team. The Senior Manager will be responsible for providing sponsor oversight of CMO QC labs in support of clinical manufacturing, establishment of internal QC processes, and maintenance of the control strategy for investigational products. The role will report to the Associate Director, Quality Control.

Requirements:

• Bachelor's degree with 8+ years of pharmaceutical manufacturing and/or Quality Assurance experience, with at least 2 years' experience in the field of overseeing cell therapies contract labs preferred.
• Experience with method transfer from Analytical Development to QC and to/from external labs.
• Expertise with cGMP analytical requirements, including regulatory regulations and requirements for biopharmaceutical products and ATMPs.
• Demonstrated ability to manage laboratory personnel in a GMP setting, including training, establishment of laboratory procedures, and stability program maintenance.
• Experience in statistical evaluation of analytical trend data.
• Deep knowledge and experience in various analytical methods employed for cell therapy products, including flow cytometry, molecular/PCR-based assays, cell-based potency assays, and safety testing.
• Must be willing to travel periodically, as needed, no more than 25% of the time.
• Manage and advance multiple projects simultaneously and dynamically reprioritize as needed.

Responsibilities:

• In collaboration with Analytical Development and other groups, support analytical control strategies for clinical products including ownership of product specifications.
• Develop and maintain stability program, including establishment of trend monitoring and statistical evaluation practices.
• Manage Validation/Qualification of Analytical methods as needed, to support multi-phase clinical trials.
• Provide subject matter expertise in the investigation of laboratory deviations, out of trend (OOT) and out of specification (OOS) events.
• Maintain internal Quality Control data management and review process, and Certificate of Analysis (COA) generation.
• Support Manufacturing to develop and monitor key performance indicators and risk registry to ensure effective oversight of contract/external laboratories.
• Ensure QC issues are identified and managed through to resolution in a timely manner and deliverables are met as required.
• Work with functional leadership to design, implement and maintain Risk Based Quality Management strategies in support of clinical programs.
• Support business development due diligence projects as needed to support analysis and assessment of internal/external laboratory capabilities.