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Parenteral Commercialization Technology Transfer Lead

Parenteral Commercialization Technology Transfer Lead

Eli LillyIndianapolis, IN, US
30+ days ago
Job type
  • Full-time
Job description

Commercialization Technology Transfer Lead, Central PPN TS / MS

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.

The Commercialization Technology Transfer Lead, Central PPN TS / MS, is responsible for technical leadership during technology transfers of parenteral drug product new molecular entities to internal Lilly sites or external contract manufacturers. This role will interact and partner with numerous functions, including development, engineering, regulatory, and quality, to design the technology transfer plan, studies, etc. Additionally, this role will work closely with the Global Commercialization Steward and Global Molecule Stewards to ensure alignment in commercialization practices and study designs to support successful product transfer. The Commercialization Technology Transfer Lead must have strong interpersonal and communication skills. A person in this position needs to have previous experience in the commercialization of parenteral products and is expected to adhere to required technology transfer guidance and requirements. This position is an individual contributor role in a scientific track.

Key Objectives / Deliverables :

  • Lead / co-lead technology transfer meetings
  • Serve as manufacturing technology transfer lead on the transfer of new molecules to internal Lilly sites or external contract manufacturers
  • Author / co-author commercial manufacturing sections of regulatory submissions and technology transfer documents associated with the transfer of new molecules
  • Partner with development and the global molecule steward to develop control strategy
  • Conduit for communication between the technology transfer team and its associated CMC team, in partnership with global molecule steward
  • Attend and / or present at governance forums
  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals

Basic Requirements :

  • Bachelor's, Master's, or PhD in chemistry, pharmacy, engineering, or other related scientific disciplines
  • 10+ years experience supporting the commercialization / manufacturing of parenteral products
  • 5+ years experience in parenteral technical transfer
  • Additional Preferences :

  • Written and oral communication skills
  • Understanding of cGMP's, policies, procedures, and guidelines
  • Demonstrated technical leadership of cross-functional teams
  • Technical knowledge of parenteral products and control strategies
  • Strong interpersonal and teamwork skills
  • Strong self-management and organizational skills
  • Additional Information :

  • Some travel (domestic and / or international) may be required (up to 25%)
  • This is NOT a remote role and requires on site presence
  • 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 for further assistance.

    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 $114,000 - $198,000. 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.

    #WeAreLilly

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