Director, Analytical Development and Clinical Quality Control
Disc Medicine
Senior Director – Technical Services and Manufacturing Sciences, Tech Transfer
Eli Lilly and Company
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $151,500 - $244,200 per year
Job Level
Senior
About the role
- Lead global technical teams in successful transfer of drug substance and dry oral products (including SDD) across internal and external manufacturing sites
- Develop standardized business processes and Playbooks to support global tech transfers across multiple platforms and multiple sites (including simultaneous transfers to dual sourcing sites)
- Ensure alignment of Playbooks with Single Process Map deliverables and obtain buy-in from BR&D/SMDD and Analytical (AQCL)
- Structure team to own and continuously improve Tech Transfer Playbooks and associated training programs
- Ensure consistency in technical deliverables and documentation across transfers
- Partner with CMC PMs and development teams to guide tech transfer execution using Lilly’s Single Process Map
- Co-own commercialization playbooks with Commercialization and Molecule Stewards
- Ensure adequate staffing and capability of tech transfer teams and provide escalation and troubleshooting support for complex tech transfer challenges
- Represent TSMS at governance bodies and technical network meetings; build relationships and influence across manufacturing sites and central functions
- Lead performance management, talent development, succession planning, and mentor project managers and technical leaders
- Contribute to long-term business planning and organizational capability development
- Some domestic and international travel may be required
Requirements
- Minimum: B.S. in Chemistry, Pharmacy, Engineering, or related scientific discipline
- Preferred: Master’s or Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or Microbiology
- 15+ years in pharmaceutical manufacturing or technical services within a cGMP environment
- 5+ years of experience in drug substance or dry product tech transfer and commercialization
- Proven leadership in cross-functional teams and successful molecule transfers
- Deep technical knowledge of parenteral products and control strategies
- Strong project management and strategic planning skills
- Excellent communication and stakeholder engagement skills
- Ability to influence across sites and central functions
- Experience mentoring and developing technical talent
- Some domestic and international travel may be required
