Advisor Process Analytical Technologies Lilly Medicine Foundry
About The Position
Lilly is investing $4.5 billion to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. This facility will combine research and manufacturing to optimize processes, increase capacity for clinical trial medicines, reduce costs, and minimize environmental impact. During the Project Delivery and Startup Phases (2025-2028), roles will be dynamic, supporting project delivery, organizational build-up, and the implementation of systems and business processes for GMP operations. This requires collaboration, creativity, and resilience. The Process Analytical Technology (PAT) Advisor is a technical-track position seeking a collaborative and energetic PAT scientist to lead PAT strategies for synthetic and biologic drug substance production at the Lilly Medicine Foundry. This role will collaborate with CMC development to understand portfolio needs and implement PAT in production. The facility will use the latest automation for analytical capabilities, including on-line in-process control testing through material release and ongoing process monitoring. The PAT group will comprise high-level scientists focused on implementing new technologies and analytical process improvements. This position involves cross-functional collaboration within the site and across the network to develop strategic functional capabilities, ensuring capacity, capabilities, and business processes are developed, implemented, and sustained to provide necessary information to project teams. A key aspect of this role is ensuring a strong safety culture and fostering a mindset of safety, quality, and continuous improvement.
Requirements
- Ph.D. in chemistry, chemical engineering, or related field; OR B.S. or M.S. with 10+ years of experience.
- A background in process analytics with a strong focus on LC/MS, GC/MS preferred.
- Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization.
- Proven skills developing, validating, and transferring analytical methods.
- Fundamental knowledge of cGMP compliance requirements and cGMP experience.
Nice To Haves
- Experience with product development, including technical transfer of analytical methods into manufacturing operations.
- Demonstrated ability to drive and accept change.
- Good interpersonal skills and a sustained tendency for collaboration.
- Demonstrated success in persuasion, influence, and negotiation.
- Ability to prioritize multiple activities and manage ambiguity.
- Must possess strong communication (oral, written), organizational, and leadership skills.
Responsibilities
- Drive implementation of technical solutions and analytical strategies via PAT to enable drug substance production at the Lilly Medicine Foundry.
- Provide technical leadership for the adoption and use of PAT to be executed at the Lilly Medicine Foundry.
- Investigate the feasibility of instruments to use for in-line monitoring.
- Ensure methods are technically sound, well developed, and fit-for-purpose.
- Support automation development (i.e., integrated control systems) between PAT tools and process data systems (i.e., synTQ or other systems).
- Mentor and develop scientific staff.
- Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.
- Plan and manage short-term and long-term development activities.
- Develop and/or review technical agendas and timelines for project work.
- Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
- Collaborate closely with organizations across development and manufacturing to deliver material and information for clinical trials and regulatory submissions.
- Welcome varied perspectives to create new solutions.
- Coordinate instrumentations between different projects to allow equal usage of available tools for project specific needs.
- Author or contribute to technical documents including SOPs, technology transfer documents, process flow diagrams, regulatory submissions, patents, and scientific papers.
- Ensure work and team activities are aligned with all relevant development quality, regulatory, HSE, GLP and GMP requirements.
Benefits
- company bonus (depending, in part, on company and individual performance)
- 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)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
