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.

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.

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.
• Technical skills in laboratory testing and sampling.
• Knowledge of regulatory requirements and compliance.
• Ability to lead and mentor laboratory staff.

Benefits

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

In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

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.