Associate Director - Engineering API EM Peptides & LM

BioSpace; Indianapolis (IN); On-site; USD 120,000 - 150,000; Full time

Job summary

A global healthcare leader in Indianapolis is seeking an Associate Director for Engineering in API EM with a focus on Peptides and Large Molecules. The role involves leading engineering efforts, mentoring associates, and ensuring quality in manufacturing processes. Candidates should possess a B.Sc. in Chemical Engineering and over 7 years of relevant industry experience.

Qualifications

• 7+ years of experience in manufacturing operations and process engineering roles.
• Experience in capital delivery projects and commercialization.

Responsibilities

• Lead engineering for Peptides and Large Molecules within the API EM Plant Team.
• Coach and mentor engineering associates.
• Provide oversight and support to process engineers.

Skills

Chemical engineering principles

Process understanding

Project management

Team leadership

Education

Bachelor of Science degree in Chemical Engineering

Job description

Join to apply for the Associate Director - Engineering API EM Peptides & LM role at BioSpace

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.

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.

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.

• 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

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

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 for further assistance.

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.