Lilly is looking to solve the business and technical problem of ensuring the reliable supply of medicines through effective and efficient manufacturing processes, while maintaining technical excellence and compliance for both day-to-day operations and new product commercialization, specifically focusing on externally manufactured products.
Requirements
- Knowledge and ability to apply basic statistical tools.
- Regulatory related experience.
- Prior experience supporting drug product parenteral manufacturing.
- A thorough understanding of cGMPs and drug product manufacturing.
- High degree of technical curiosity and critical thinking.
- High learning agility.
- Use of data and science to support decisions.
Responsibilities
- Provide oversight to ensure reliable supply of medicines through effective and efficient manufacturing process.
- Ensure capable and in control processes at CMs. Establish and maintain robust control strategy for all manufacturing/packaging/distribution operation and those meet the Lilly standards/expectations.
- Ensure process definition of critical parameters are in alignment with regulatory submission.
- Ensure that each of the department and external partner operate in compliance with cGMPs, regulatory commitments and Lilly Functional Standards though appropriate oversight. Ensure inspection readiness at all times.
- Ensure Quality of the externally manufactured products through appropriate oversight, CAPAs, metrics and monitoring systems.
- Validation: ensure proper definition of strategies, revisions, protocol approvals, validation plans, final reports and master plan. Approve strategy documents and applicable protocols.
- Change Control: Properly evaluate and assess impact of proposed changes to validated processes, regulations, relationship and regulatory commitments.
Other
- Bachelors Degree in Pharmacy, Chemistry, Engineering, or similarly related fields.
- 5+ years’ experience in pharmaceutical manufacturing in technical services and/or quality.
- Previous leadership experience.
- Good communication skills, especially attention to detail in written procedures and protocol development.
- Strong leadership, interpersonal and teamwork skills, able to work effectively in a team environment.
