Associate Director - Engineering API EM Peptides & LM at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

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
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

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
Ensure 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
Ensure 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
Adhere to the expectations of the Lilly Red Book when carrying out interactions with API EM’s CMs

Skills

Process Engineering

Engineering Leadership

HSE

PSM

API Manufacturing

Peptides

Large Molecules

Problem Solving

Engineering Design

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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