IDAP Commercialization Manager

Lilly • Indianapolis, IN

1d • $123,000 - $180,400 • Onsite

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 and 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.

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
• Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals
• Device assembly and / or packaging experience
• Previous supervisory experience

Responsibilities

• Technical and defendable process support service
• Performance management and development of staff
• Technical review and approval for site quality documents, plans, validation-related documents and studies.
• Effectively encourage knowledge sharing and education within team and with key internal partners: Operations, Quality Assurance, Quality Control Labs, Logistics, Engineering and Site Technology Transfer Team.
• Ensure the Commercial Launch activities are aligned and drive to meet Site manufacturing goals through technology transfers, daily operation of the manufacturing plants, deviation and change management, variability reduction, and equipment / system reliability.
• Alignment of all functional areas; Technical Services, Engineering, Utilities, Quality and Operations leadership to deliver operational results for Clinical Trials and Commercial Launch.
• Represent 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level