Sr. Director - Biologics Operations - Lilly Medicine Foundry

Eli Lilly and Company; Lebanon (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a Senior Director for Foundry Operations in Biologics. This pivotal role involves leading operations for a groundbreaking facility focused on drug manufacturing. The ideal candidate will drive the establishment of a safety culture, oversee the integration of cross-functional teams, and ensure compliance with regulatory standards. With a commitment to innovation and operational excellence, this position offers the chance to shape the future of drug development while fostering a collaborative and high-performing team environment. If you're passionate about making a difference in healthcare, this opportunity is for you.

Qualifications

• 5+ years of leadership experience in operations within the pharmaceutical industry.
• Strong knowledge of cGMPs and effective relationship building at all levels.

Responsibilities

• Lead the organization to ensure safety, quality, and operational excellence.
• Develop strategic and operational plans for Production Operations.

Skills

Leadership

Operations Management

Project Management

Process Safety Management

Regulatory Compliance

Team Building

Continuous Improvement

Education

Bachelor's degree in a relevant scientific, engineering or operations discipline

Job description

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.

Overview:

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, implement the necessary systems and business processes required to support GMP operations and build the site culture. This will require significant collaboration, creativity and resilience as the Lilly Medicines Foundry goes from design to start-up to steady-state operations.

The Biologics Facility is responsible for the manufacture of drug substance (DS) produced from mammalian cell culture, which includes monoclonal antibodies and antibody-like proteins, as well as some antibody containing bioconjugates.

The Senior Director Foundry Operations Biologics is directly responsible for managing the operations function and ensuring it has the necessary capacity, capability and leadership structures in place to deliver the site plan. The role is also responsible for leading the integration of the cross-functional management team that provides functional support to Biologics operations. This role will be key to ensuring a strong safety culture and establishing a safety, quality and continuous improvement focused mindset within the organization.

Responsibilities:

Pre-Startup and Startup Phase:

• Be a collaborative, inclusive, energetic leader and support the broader lead team to:
• Attract, hire and onboard a significant number of top talent to the Foundry team establishing the right attitude, curiosity and learning agility to deliver on the Foundry mission.
• Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of safety, quality, and operational excellence.
• Develop and implement the systems and processes needed to run the site, leveraging existing Lilly knowledge where necessary, but also incorporating external learning.
• Establish lean practices and a continuous improvement mindset throughout operations and the direct supporting organizations.
• Support the project team to deliver the facility to you as the end user, by providing feedback and support on design decisions, commissioning strategies etc. Collaborate with them to ensure the right decisions are made to meet project deliverables and longer-term strategic goals for the site.
• Partner with Process Research and Development (PR&D) leadership to ensure the Operations group and broader Foundry operating system/culture reflects the speed, innovation, flexibility and reliability needed to meet PRD and partnering organizations’ needs.
• Plan and manage business operational expense, capital and headcount targets. Work effectively with Process Development Project Managers to maximize the throughput and utilization of the facility as well as maintain the schedule.

Post Startup:

• Develop the strategic and operational plans for Production Operations and be responsible for the execution of these plans in his/her areas of direct responsibility.
• Participate in development and delivery of the medium and long term strategic direction for the site.
• Ensure Biologics operations remain compliant with all applicable regulatory requirements. (e.g. Safety, Quality/cGMP, Environmental, Financial, Legal, HR.)
• Ensure the Flow Team and Process Teams are set up to deliver operational success.
• Ensure that a robust control system exists to manage the business, identify compliance issues and escalate issues appropriately is established and maintained.
• Review site and area performance periodically with respect to these plans and take corrective actions as appropriate.
• Through leadership of the cross functional management support team, be responsible for delivering on the diverse and evolving development portfolio, meeting speed and reliability expectations while accommodating flexibility to meet changing priorities in the clinical space. In parallel with delivering the portfolio, continue to pursue improvement opportunities related to both strategic and essential capabilities.
• Develop the future management and technical leadership for the site and for potential assignments in PR&D and manufacturing.

Basic Requirements:

• Minimum of a bachelor's degree (or equivalent) in a relevant scientific, engineering or operations discipline and a minimum of 5 years of experience in a leadership role managing operations or relevant experience within the pharmaceutical industry.

Additional Preferences:

• Experience in operations including a Process Safety Management program.
• Must possess knowledge and understanding of cGMPs and how they apply to operations.
• Must have a strong ability to form effective relationships at all levels. This candidate must be able to work closely with the FLT to ensure alignment with corporate and PR&D objectives and internal decision making processes as well as be able to connect and communicate effectively with all levels of the organization on site.
• Should have a demonstrated track record of successfully developing, managing and executing projects from start to finish on time and within budget with high performance standards that ensure customer satisfaction.
• Should have experience developing and managing extremely talented, engaged and high performing teams with a focus on building strong team cultures to ensure a safe, innovative and successful work environment.
• Ability to lead and influence a diverse team, including employees across a wide range of experiences, levels and skill sets.

*NOTE: final location for this role will be Lebanon, IN site but flexibility to work from Indianapolis will be required throughout 2025 and 2026.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.