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 (<5%)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$123,000 - $180,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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