IDAP Commercialization Manager
About The Position
The Commercialization Manager in Indianapolis Device Assembly & Packaging Operations is responsible for overseeing the Commercialization mission for the IDAP site per Manufacturing Standard for Operational Excellence (MSOE) 201. In addition, this position is responsible for leading/mentoring a technical staff and understanding device assembly, dry packaging and parenteral packaging processes. This includes responsibility for developing and implementing the organization’s technology transfer agenda, coordination, integration, replication and implementation of IDAP Site business and Quality Systems for the Commercial Launch activities. Influence and implement the commercial technical agenda within a multi-discipline technical environment. Work with peer leadership in a positive fashion to deliver on functional technical objectives, specific product business plan, and quality objectives. Key position responsibility is to address and document GMP compliance issues and development/execution of validation plans.
Requirements
- Bachelor’s degree in Science or Engineering or equivalent experience
- At least 5 years of pharma experience
- Previous demonstration of strong leadership skills
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
- Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals
- Ability to wear safety equipment (safety glasses, safety shoes, protective gloves, respirator, etc.)
Nice To Haves
- Strong interpersonal and communication skills
- Understanding of statistical process control and Six Sigma concepts
- Solid understanding of quality and corporate policies
- Solid understanding of the importance of and basic requirements of Regulatory agencies such as the FDA, EMA, OSHA, and EPA
- Comprehension of MSOE’s
- Demonstration of solid judgment and initiative
- Device assembly and / or packaging experience
- Previous supervisory experience
- Some travel may be required (<5%)
Responsibilities
- Overseeing the Commercialization mission for the IDAP site per Manufacturing Standard for Operational Excellence (MSOE) 201.
- Leading/mentoring a technical staff and understanding device assembly, dry packaging and parenteral packaging processes.
- Developing and implementing the organization’s technology transfer agenda.
- Coordination, integration, replication and implementation of IDAP Site business and Quality Systems for the Commercial Launch activities.
- Influencing and implementing the commercial technical agenda within a multi-discipline technical environment.
- Working with peer leadership in a positive fashion to deliver on functional technical objectives, specific product business plan, and quality objectives.
- Addressing and documenting GMP compliance issues and development/execution of validation plans.
- Representing their team on the plant flow teams.
Benefits
- company bonus (depending, in part, on company and individual performance)
- company-sponsored 401(k)
- pension
- vacation benefits
- 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
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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What This Job Offers
Job Type
Full-time
Career Level
Manager
