Eli Lilly and Company · 1 day ago
Associate Director - Engineering API External Manufacturing Peptides & Large Molecules
Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and delivering life-changing medicines. The Associate Director - API EM Engineering Leader for Peptides and Large Molecules will provide leadership and expertise to ensure reliable supply and commercialization of externally manufactured APIs, while prioritizing safety and quality.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Provide API EM organizational Engineering leadership for Peptides and Large Molecule as a member of the APIEM Plant Lead Team, HSE Lead Team, Science Lead Team, and co-lead the Engineering Lead Team
Coach and mentor engineering associates in aspects of fundamental engineering support, including process knowledge, problem solving and engineering design
Provide administrative oversight and support to a team of process engineers across multiple geographies
Develop and provide ongoing leadership for a PSM program within API EM with the goal of improving PSM capabilities and performance at CMs
Responsible for ensuring assessments of the HSE and PSM capabilities of each CM impacting Lilly products are completed during the sourcing process and maintained during the product lifecycle at a CM
Responsible for ensuring FUME assessments of CMs to understand risks presented to Lilly products control strategy are completed and maintained
Lead Lilly internal resources (API EM, ETC, others as required) and partner with CM (Contract Manufacturer) resources in the execution of HSE, PSM and FUME capability assessments of CMs
Lead internal resources and partner with CMs through specification, procurement, and IQ/OQ/PQ of equipment to ensure capital projects at CMs are delivered on time, within budget and meeting technical expectations
Adherence to the expectations of the Lilly Red Book when carrying out interactions with API EM’s CMs
Qualification
Required
Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive pharmaceutical manufacturing experience
7+ years of work experience in a manufacturing operations and process engineering related roles
Preferred
Demonstrated ability to apply fundamental chemical engineering principles to process understanding, problem solving, and process improvement
Demonstrated ability to manage capital delivery project or commercialization / technical agenda projects
Deep technical knowledge of bulk API manufacturing equipment and unit operations
Demonstrated ability to understand and influence integration points with other business areas, processes, and functions
Direct or indirect experience with commercialization (Validation, Tech Transfer, CMC, GMP, Quality, and/or HSE)
Demonstrated ability to function in a team environment as a leader and as a member of teams
Demonstrated ability to manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences
Experience in typical unit operations for large molecule expression and purification and small molecule manufacture
Process Hazard Analysis experience
Project management qualifications or demonstrated ability to develop detailed project plans including critical path and risk register analysis
Benefits
Company bonus
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)
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
Represents job field similar to this job
Trends of Total Sponsorships
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
2026-01-13
GlobeNewswire
2026-01-13
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