Advisor Process Analytical Technologies for Biologics Lilly Medicine Foundry

Lilly • Lebanon, IN

1d • $126,000 - $204,600 • Onsite

About The Position

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. In the Project Delivery Phase and Startup Phase of the project (2025 to 2028), roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations. This will require significant collaboration, creativity and resilience as the Lilly Medicine Foundry goes from design, to start-up, and to steady-state operations. The Process Analytical Technology Advisor role, a technical-track position, seeks a collaborative, inclusive, and energetic Process Analytical Technology (PAT) scientist who will lead the PAT strategies to be utilized at the Lilly Medicine Foundry to support the production of biologic drug substance processes. This role will collaborate with the parent CMC development organizations to understand the needs of the portfolio and PAT to be implemented in production. The Lilly Medicine Foundry, a state-of-the-art facility, will utilize the latest in automation to further the analytical capabilities including on-line in-process control testing through material release and on-going process monitoring at the site. The PAT group will consist of high-level scientists focused on the implementation of new technologies and analytical process improvements. This position involves working cross-functionally within the site and across the network to develop strategic functional capabilities and will ensure appropriate capacity, capabilities and business processes are developed, implemented and sustained to deliver the required information to the project teams. This position will be key to ensuring a strong safety culture and establishing a safety, quality and continuous improvement focused mindset within the organization.

Requirements

• Ph.D. in biochemistry, chemical engineering, biochemical engineering or related STEM field; M.S. with 10+ years of experience.
• A background in process analytics with a strong focus on bioprocess analytics, including spectroscopic methods, chromatographic techniques, and/or cell culture monitoring.
• 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 biologic drug substance production at the Lilly Medicine Foundry.
• Provide technical leadership for the adoption and use of PAT (e.g., Raman, UV, capacitance) in upstream and downstream biological processes 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.
• Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas (e.g., biochemistry, PAT, and modeling and simulation).
• 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
• company-sponsored 401(k)
• pension
• vacation benefits
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree