Parenteral Commercialization Technology Transfer Lead

About the position

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.

Responsibilities

• 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

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

Nice-to-haves

• 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

Benefits

• 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
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)