Eli Lilly and Company · 3 hours ago
Associate Director Process Engineering - Peptides API
Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and bringing life-changing medicines to those in need. The Associate Director of Process Engineering - Peptides API will provide leadership and direction to the process engineering team, ensuring the productivity and development of engineers while overseeing the startup of a new manufacturing facility.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Attract, hire, and onboard a significant number of top talent to the Peptides 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 where necessary, but also incorporating external experience
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 & qualification strategies etc
Collaborate with 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
Responsible for supervising and coaching 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 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 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
Qualification
Required
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 and/or peptides GMP manufacturing environment required
3+ years of experience in manufacturing leadership
Preferred
Experience in operations including a Process Safety Management (PSM) 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
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
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
Benefits
Company bonus (depending, in part, on company and individual performance)
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)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
Recent News
2025-12-30
2025-12-30
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