IDAP Commercialization Manager
Eli Lilly and Company
18 days ago
On-site
Indianapolis, IN
Marketing
Position: Commercialization Manager (Indianapolis, Device Assembly & Packaging Operations)
Responsibilities:
- Oversee the Commercialization mission for the IDAP site per MSOE 201.
- Lead/mentor a technical staff and support device assembly, dry packaging, and parenteral packaging processes.
- Develop and implement the technology transfer agenda and support Commercial Launch activities, including business and Quality System coordination/integration/replication.
- Influence and implement the commercial technical agenda in a multi-discipline environment.
- Work with peer leadership to deliver on functional technical objectives, product business plan, and quality objectives.
- Address and document GMP compliance issues and develop/execute validation plans.
- Provide technical/process support, manage and develop staff, and review/approve site quality documents and validation-related studies.
- Encourage knowledge sharing with internal partners (Operations, QA, QC Labs, Logistics, Engineering, Site Technology Transfer).
- Align Commercial Launch activities to meet manufacturing goals via technology transfers, daily plant operations, deviation/change management, variability reduction, and equipment/system reliability.
- Represent the team on plant flow teams.
Minimum Requirements:
- Bachelor’s degree in Science or Engineering (or equivalent experience)
- At least 5 years of pharma experience
- Demonstrated strong leadership skills
- Authorized to work in the United States full-time (Lilly will not sponsor visas)
Additional Preferences:
- Strong interpersonal/communication skills
- Knowledge of statistical process control and Six Sigma
- Understanding of quality/corporate policies and regulatory basics (FDA, EMA, OSHA, EPA)
- Comprehension of MSOE
- Solid judgment/initiative
- Accountable for HSE goals; safe work practices
- Device assembly and/or packaging experience; prior supervisory experience
Other:
- Direct interaction with Regulatory Agencies during inspections
- Ability to wear safety equipment; some allergens present
- Some travel may be required
Benefits (as stated): Eligible employees may participate in a company-sponsored 401(k), pension, vacation; medical/dental/vision/prescription coverage; flexible benefits (FSA); life insurance and death benefits; certain time off/leave; well-being benefits (EAP, fitness, clubs). Anticipated pay: $123,000–$180,400; full-time equivalents may be eligible for a company bonus.
Responsibilities:
- Oversee the Commercialization mission for the IDAP site per MSOE 201.
- Lead/mentor a technical staff and support device assembly, dry packaging, and parenteral packaging processes.
- Develop and implement the technology transfer agenda and support Commercial Launch activities, including business and Quality System coordination/integration/replication.
- Influence and implement the commercial technical agenda in a multi-discipline environment.
- Work with peer leadership to deliver on functional technical objectives, product business plan, and quality objectives.
- Address and document GMP compliance issues and develop/execute validation plans.
- Provide technical/process support, manage and develop staff, and review/approve site quality documents and validation-related studies.
- Encourage knowledge sharing with internal partners (Operations, QA, QC Labs, Logistics, Engineering, Site Technology Transfer).
- Align Commercial Launch activities to meet manufacturing goals via technology transfers, daily plant operations, deviation/change management, variability reduction, and equipment/system reliability.
- Represent the team on plant flow teams.
Minimum Requirements:
- Bachelor’s degree in Science or Engineering (or equivalent experience)
- At least 5 years of pharma experience
- Demonstrated strong leadership skills
- Authorized to work in the United States full-time (Lilly will not sponsor visas)
Additional Preferences:
- Strong interpersonal/communication skills
- Knowledge of statistical process control and Six Sigma
- Understanding of quality/corporate policies and regulatory basics (FDA, EMA, OSHA, EPA)
- Comprehension of MSOE
- Solid judgment/initiative
- Accountable for HSE goals; safe work practices
- Device assembly and/or packaging experience; prior supervisory experience
Other:
- Direct interaction with Regulatory Agencies during inspections
- Ability to wear safety equipment; some allergens present
- Some travel may be required
Benefits (as stated): Eligible employees may participate in a company-sponsored 401(k), pension, vacation; medical/dental/vision/prescription coverage; flexible benefits (FSA); life insurance and death benefits; certain time off/leave; well-being benefits (EAP, fitness, clubs). Anticipated pay: $123,000–$180,400; full-time equivalents may be eligible for a company bonus.