IDAP Commercialization Manager

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Position Brand Description:

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. Key Objectives /

Deliverables:

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

Minimum 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.

Additional Preferences:

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

Education Requirements:

Bachelor's degree in Science or Engineering or equivalent experience

Other Information:

This role has direct interaction with Regulatory Agencies during inspections Ability to wear safety equipment (safety glasses, safety shoes, protective gloves, respirator, etc.) Some allergens are present in the plant Some travel may be required (