Parenteral Commercialization Technology Transfer Lead

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 <