Associate Director Process Engineering - Small Molecule API

Eli Lilly and Company • Lebanon, IN

1d • Onsite

About The Position

The Associate Director Process Engineering – Small Molecule Active Pharmaceutical Ingredients (API) provides leadership and direction to process engineers, ensuring engineering deliverables are sufficiently resourced and qualified to support Small Molecule production and business objectives. This role is responsible for the productivity and development of process engineers, aiming to ensure reliable and compliant equipment and systems are used in manufacturing small molecule products. The Associate Director leads the process engineering organization and influences across functional disciplines to support the process engineering agenda, business plan priorities, and compliance plan objectives. During the project delivery and startup phases (expected 2026 to 2028+), leadership roles will be dynamic, supporting project delivery teams, building a new organization, developing and implementing necessary business processes for GMP operations, and fostering the site culture. This requires significant collaboration, creativity, and resilience as the site scales to full API GMP manufacturing.

Requirements

• Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive API or chemical manufacturing experience
• 3+ years of experience and proven capabilities within small molecule GMP manufacturing environment
• 3+ years of experience in manufacturing leadership

Nice To Haves

• Experience in operations including a Process Safety Management (PSM) program.
• Knowledge and understanding of cGMPs and how they apply to operations.
• Strong ability to form effective relationships at all levels.
• Ability to work closely with the Site Engineering Group to ensure alignment with corporate and Manufacturing & Quality objectives and internal decision-making processes.
• Ability to connect and communicate effectively with all levels of the organization on site.
• 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.
• 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.
• Ability to work with a team, make independent decisions, and influence diverse groups.
• Ability to instill teamwork within the department and demonstrate key interpersonal skills.
• Ability to provide innovative solutions to plant, divisional, and corporate issues and leverage ideas from other functional areas.

Responsibilities

• Attract, hire, and onboard top talent to the Small Molecule Process Engineering team, establishing the right attitude, curiosity, and learning agility to deliver on the site 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 business systems and processes needed to run the site, leveraging existing Lilly knowledge and incorporating external experience.
• Establish lean practices and a continuous improvement mindset throughout operations and direct supporting organizations.
• Support the project team to deliver the facility to the end user, by providing feedback and support on design decisions, commissioning & qualification strategies.
• Collaborate with the project team to ensure the right decisions are made to meet project deliverables and longer-term strategic goals for the site.
• Organize and implement strategy for creating engineering standard operating procedures (SOPs) for startup and post startup phases.
• Partner with Process Research and Development (PR&D) leadership to ensure the Operations teams reflect the speed, innovation, flexibility, and reliability needed to meet PR&D and partnering organizations’ needs.
• Plan and manage business operational expenses, capital, and headcount targets.
• Supervise and coach process engineering staff for their respective area, including completing performance reviews and development planning.
• Provide oversight of process engineering staffing including recruitment, resource planning, and succession planning.
• Provide process engineering work coordination and provide process engineering input to key functional groups and partners.
• In coordination with the engineering function, set and reinforce standards for engineering work product and utilization of first principles.
• Partner within Engineering and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
• Identify, track, and report key indicators of functional performance.
• Have oversight of engineering related technical issues and improvement initiatives.
• Review and approve engineering related deviations and change controls.
• Review and approve engineering standard operating procedures (SOPs).
• Participate appropriately in site planning processes (capital and resource), representing the interests of the team but with a view to the overall site picture.
• Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.
• Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits.
• Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.
• Develop the strategic and operational plans for 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 Small Molecule operations remain compliant with all applicable regulatory requirements. (e.g., Safety, Quality/cGMP, Environmental, Financial, Legal, HR.)
• Review site and area performance periodically with respect to these plans and take corrective actions as appropriate.
• Develop the future management and technical expert leadership for the site.

Benefits

• Company bonus (depending, in part, on company and individual performance)
• Company-sponsored 401(k)
• Pension
• Vacation benefits
• Medical benefits
• Dental benefits
• Vision benefits
• 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: Manager
• Number of Employees: 5,001-10,000 employees