Associate Director - Engineering API External Manufacturing Peptides & Large Molecules

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.

Organization Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Responsibilities: 

The Associate Director - API EM Engineering Leader for Peptides and Large Molecule is a member of the API EM Plant Lead Teams providing leadership and expertise to reliably supply and commercialize externally manufactured APIs, intermediates and starting materials with safety first and quality always. The role reflects increasing technical complexity and commercialization activity associated with API EM operations as the pipeline portfolio progresses.

Engineering/HSE

• 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.

Basic Requirements:

• 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
• Must have technical experience in Drug Substance / Active Pharmaceutical Ingredients (API) manufacturing
• Leadership experience, leading engineering teams and/or large engineering projects (tech transfers, capital projects)

Additional Preferences:

• 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

This role is located in Indianapolis, IN and is not approved for remote work.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$118,500 - $173,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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