Director - QC Advanced Therapies LP2 Quality

About the role

The Associate Director (AD) is the laboratory leader role in the LP2 Quality Control Laboratory providing 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 will serve 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. This includes 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. This includes interaction 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 be responsible for providing 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.
• Comply with and implement safety standards.
• Help develop a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
• Interact effectively with internal business partners to communicate and resolve issues and gain a clear and accurate understanding of each other’s requirements.
• Network with groups internal and external to Lilly to understand best practices, share knowledge, participate in technical planning, and to ensure customer needs are met.
• 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.

Qualifications

• 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.

Skills

• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Knowledge of cGMP regulations and laboratory testing.
• Experience with laboratory management and start-up.
• Problem-solving and root cause analysis skills.

Benefits

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $123,000 - $180,400. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Pay

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

Schedule

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).