Director - QC Advanced Therapies LP2 Quality

About the role

The Associate Director (AD) role in the LP2 Quality Control Laboratory provides direction for the start-up project phase as well as the operational areas of the laboratory. This involves the design and execution for the area’s daily workload planning and compliance. The AD serves as a liaison between the site leadership and global laboratory leadership to ensure timely start-up and laboratory testing delivery.

Responsibilities

• Proactively manage day-to-day laboratory business, including interaction with GFD and construction teams, as well as internal teams for laboratory start-up and execution of testing.
• Proactively manage day-to-day personnel, interacting with production planners, sample submitters, analysts, and other cross-functional groups to maintain laboratory workload and throughput.
• Maintain a high-level understanding of the laboratory processes and provide site leadership information about laboratory capacity, capability, and forward planning for current molecules and new product introduction.
• Develop career plans for laboratory SMEs, project managers, analysts, and technicians.
• Monitor and assure compliance to all procedures, methods, and other regulatory commitments.
• Provide technical understanding of the regulations applicable to laboratory testing and sampling for cGMP purposes.
• Participate in internal audits and external inspections.
• LIMS usage, implementation, and deployment support by providing strategic oversight.
• Utilize technical skills to support investigations into out of spec results and aberrant data.
• Improve lab quality systems; develop content, review, and approve SOPs and training as necessary.
• Contribute to development and implementation of Global Lab Quality Standards.
• Help define and execute inspection readiness activities in the QC laboratories.

Requirements

• Bachelor's degree in a science field related to chemistry, microbiology, biology, or other science discipline.
• 5+ years of cGMP commercial manufacturing experience in QC or associated disciplines such as Manufacturing, TS/MS, Quality Assurance, or Engineering.
• 3+ years of experience leading teams.

Additional Preferences

• Experience with large molecule and/or viral vector testing techniques.
• Experience with management of laboratories or start-up of new laboratories.
• Demonstrated strong problem-solving skills.
• Demonstrated strong interpersonal interaction skills.
• Ability to focus on continuous improvement.
• Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
• Deep understanding of compliance requirements and regulatory expectations.