At Lilly, the Drug Product External Manufacturing (DPEM) organization is responsible for managing the technical, quality, supply, and financial aspects of drug product manufacturing at contract manufacturers globally. This role is crucial for ensuring the risks associated with external manufacturing are appropriate and protect the Lilly brand, while also ensuring the quality and supply of medicines to patients.
Requirements
- Parenteral or aseptic manufacturing experience is necessary
- A thorough understanding of cGMPs and drug product manufacturing
- Prior experience supporting cartridge parenteral manufacturing preferred
- High degree of technical curiosity, critical thinking and strong learning agility
- Use of data and science to support decisions
- Willingness to learn new technologies
- Knowledge and ability to apply basic statistical tools
Responsibilities
- Support On-Going Tech Transfer and subsequent commercial support at a CM(s) by providing technical oversight
- Define, understand, and own the operational control strategy; including the key process parameters and critical quality attributes
- Generate, review, revise, and maintain as needed all the manufacturing and validation documentation (e.g. master production records and packaging orders, validation plans/protocols/reports, qualification protocols/reports, Process Flow Documents).
- Ensure timely completion of annual product reviews (APRs) and Ongoing Process Verification (OPV), with action plans defined and monitored to ensure processes are in control, capable and in continuous improvement.
- Monitor critical process parameters, react to special/common cause and proactively generate improvement opportunities.
- Lead Root Cause Analysis investigation and provide process expert knowledge in all deviations and complaints
- Develop and own the Technology Transfer Plan. Define (with the project lead and/or global molecule steward) the appropriate validation strategy according to the Regulatory and Lilly Standard expectation.
Other
- Bachelors Degree in Pharmacy, Chemistry, Engineering, or similarly related fields
- 3+ years experience in pharmaceutical manufacturing and/or technical services
- 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
- Willingness to travel
