Full-Time

Associate Director

TS/MS Device & Packaging

Posted on 12/13/2025

Lilly USA

Lilly USA

10,001+ employees

Global pharmaceutical company developing medicines

Compensation Overview

$118.5k - $173.8k/yr

+ Bonus

Indianapolis, IN, USA

In Person

Occasional travel may be required.

Category
Biology & Biotech (2)
,
Requirements
  • Bachelor’s degree in Science, Engineering, or related field
  • 5+ years of manufacturing experience, pharmaceutical or regulated industry
  • 3+ years demonstrated leadership skills with a history of successful team development
Responsibilities
  • Lead, mentor, coach, and develop staff, fostering a culture of continuous improvement and operational excellence for safety, quality, and technical capability
  • Lead and provide technical and effective process support services for production issue resolution and investigations, ensuring reliable solutions, safe execution, and regulatory compliance. Foster knowledge sharing and education within the team and with key internal partners to drive alignment and meet manufacturing goals
  • Foster a culture of innovation and creativity, encouraging team members to identify and drive improvement opportunities. This position may deliver equipment, lines, and supporting systems through technology transfers, control strategy development, or process validations. Oversee and implement the organization’s technology transfer agenda, ensuring seamless integration and replication of Site business and Quality Systems for Commercial Launch/Technical Agenda activities
  • Represent the team on plant flow teams, influencing technical agendas and driving operational results. Collaborate closely with cross-functional teams, external partners, central functional organizations, and suppliers to drive alignment and resolve escalated issues
  • Manage resources effectively, including workload optimization and staffing needs, to meet business objectives. Support Site Leadership to build a diverse and capable organization, supporting the areas of device assembly and packaging
  • Engage and support business plan objectives while tracking team performance and ensuring adequate resources are in place for successful implementation
  • Lead by example in building and driving a culture of safety first and quality always within the organization while removing barriers to team performance. Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.
  • Develop and communicate department metrics to drive continuous improvement and ensure alignment to business goals. Develop team goals for safety, quality, and process effectiveness and efficiency
  • Ensure adherence to current regulatory requirements, including cGMP standards, OSHA regulations, and environmental sustainability goals. Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections
  • Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools for success. Ensure process monitoring of critical parameters occur and reactions to signals/trends are appropriate to drive control, capability, productivity, and continuous improvement for the process
Desired Qualifications
  • Knowledge of cGMP requirements in medical device manufacturing, highly preferred
  • Experience in device assembly and/or packaging
  • Understanding of basic requirements of regulatory agencies such as the FDA, DEKRA, and OSHA
  • Safety equipment (PPE) and precautions required in the manufacturing plant environment
  • Occasional travel may be required to support business needs
  • Previous equipment qualification and process validation experience
  • Previous experience with deviation and change management systems including Trackwise
  • Responsible for maintaining a safe work environment and supporting all health, safety, and environmental goals
  • Excellent interpersonal, written, and oral communication skills that demonstrate an ability to effectively communicate with all levels of the organization for decisions, influencing, coaching and mentoring

Lilly is a global pharmaceutical company that discovers, develops, and sells prescription medicines to improve health outcomes. It grows its portfolio through extensive research and development, then manufactures and distributes drugs worldwide to healthcare providers who prescribe them to patients. Lilly’s products span diabetes, cancer, immunology, pain management, and other serious conditions, including diabetes treatments tirzepatide and dulaglutide. The company emphasizes safety, efficacy, and ethical practices, and protects its products from counterfeiting while partnering with organizations such as Team USA. Its approach relies on rigorous R&D, strong manufacturing, and a global distribution network to bring medicines to patients. Lilly’s goal is to help people live better lives by delivering reliable medical solutions through a global, ethical, and quality-focused operation.

Company Size

10,001+

Company Stage

IPO

Headquarters

Indianapolis, Indiana

Founded

1876

Simplify Jobs

Simplify's Take

What believers are saying

  • $4.5 billion LEAP investment opens genetic medicine facility for ALS therapies in 2027.
  • Profluent Bio partnership worth $2.25 billion accelerates AI-driven DNA editing for Alzheimer's.
  • Mounjaro added to China's National Reimbursement Drug List boosts international sales 95%.

What critics are saying

  • French ANSM fines Lilly €108,766 for Mounjaro ads, sparking global marketing restrictions.
  • FDA hepatic failure report on Foundayo triggers label changes slashing Zepbound's $4.16 billion sales.
  • Novo Nordisk's Wegovy dominates Europe with superior supply, capturing Mounjaro market share.

What makes Lilly USA unique

  • Mounjaro generated $8.7 billion in Q1 2026, surpassing Keytruda as world's best-selling drug.
  • Lilly commands 60.1% U.S. obesity and diabetes market share over Novo Nordisk's 39.4%.
  • Tirzepatide in Mounjaro and Zepbound drove 65% of Q1 2026 revenue.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

401(k) Retirement Plan

401(k) Company Match

Paid Vacation

Flexible Work Hours

Wellness Program

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

-4%

2 year growth

-4%
The Lebanon Reporter
May 7th, 2026
Lilly invests additional $4.5B in LEAP district, opens first genetic medicine facility

Eli Lilly has announced an additional $4.5 billion investment in its Lebanon, Indiana facilities, bringing its total investment in the LEAP Innovation and Research district to $21 billion. The company opened its first Advanced Therapies site on Wednesday, marking the first operational facility in the 9,000-acre LEAP district. The new funding will support Lilly's Advanced Therapies laboratory and an active pharmaceutical ingredient facility expected to open in 2027. The Advanced Therapies site is Lilly's first dedicated genetic medicine manufacturing facility, focusing on molecular-level research for diseases including Alzheimer's, Parkinson's and ALS. Lilly is developing three facilities across 800 acres in LEAP, including a Medicine Foundry. The Advanced Therapies facility aims to accelerate delivery of breakthrough genetic medicines to patients.

AI Software Services
May 5th, 2026
Unlocking AI innovation in finance medicine and music.

Unlocking AI innovation in finance medicine and music. Published on May 05, 2026 GENETIC MEDICINE REVOLUTION: AI AND BIOTECH JOIN FORCES. In a groundbreaking partnership, Lilly and AI-driven Profluent Bio are teaming up in a deal worth up to $2.25 billion to develop advanced DNA editing tools. Their goal? To create precise treatments for genetic conditions that currently lack effective solutions, using innovative AI models to design enzymes that can target multiple mutations in the genome. This collaboration aims to unlock the "holy grail" of genetic medicine through kilobase-scale DNA editing. This matters because it could transform how AI Software Services treat genetic diseases, offering hope to millions who suffer from conditions deemed untreatable. The tools being developed are likely to be accessible, lowering barriers to entry in a field that has traditionally been expensive and exclusive. Imagine a startup that provides a platform for creators and developers to access these AI-driven genetic editing tools, enabling them to innovate and create personalized therapies. This could attract investors eager to support the next wave of medical breakthroughs!

The Economic Times
May 4th, 2026
French fines over anti-obesity adverts for Novo Nordisk, Eli Lilly.

French fines over anti-obesity adverts for Novo Nordisk, Eli Lilly. The ANSM fined Novo Nordisk 783,838 euros regarding adverts for Wegovy and also fined Lilly France 108,766 euros for a campaign promoting its anti-obesity drug Mounjaro, seeing the adverts as "likely to constitute indirect promotion of medicines subject to mandatory medical prescription." * Updated On May 4, 2026 at 05:54 PM IST Paris: France's medicine safety agency ANSM said Monday it had imposed fines on pharmaceutical firms Novo Nordisk and Eli Lilly over their advertising campaigns on obesity. The agency fined on Novo Nordisk France 1.78 million euros ($2.08 million) - a million relating to adverts promoting its Saxenda drug and 783,838 euros regarding adverts for Wegovy weight management medication for treating obesity. The ANSM also fined Lilly France 108,766 euros for a campaign promoting its anti-obesity drug Mounjaro, seeing the adverts as "likely to constitute indirect promotion of medicines subject to mandatory medical prescription." French laws prohibit any advertising to the general public of the treatments. The national medicines regulator said that the fines aimed to "prevent any communication likely to promote the use of drug treatment as the principal response to obesity, to encourage the public to request this treatment from a healthcare professional or seek to obtain it themselves." Event. * Fri, 24 Jul 2026 * Le Meridien, Hyderabad The ANSM said the advertising campaigns were "likely to mislead the public in a context marked by extensive media coverage" as well as what it termed growing inappropriate use of medications which activate certain hormones in order notably to reduce appetite,and aid weight loss. In a statement to AFP, Novo Nordisk France said it "strongly contests" the ANSM's finding, adding it is "exploring all possible appeal avenues against this decision". Lilly France said it noted ANSM's decision, while stating it believes its awareness campaign entitled "Obesity is a sick person's problem" from a year ago was "in line with the framework applicable to communications relating to human health". According to a French study published in 2024, around 18 percent of the French population - equivalent to some ten million people - are obese.

NBC News
Apr 14th, 2026
FDA requests more safety data from Lilly on weight loss pill Foundayo

The FDA is requesting additional safety data from Eli Lilly for its weight loss pill Foundayo, including information on potential heart and liver problems, according to the approval letter published Tuesday. The agency wants more data on risks including heart attacks, strokes, drug-induced liver injuries and delayed stomach emptying. Foundayo, approved this month under a fast-track pilot programme, is the second oral GLP-1 to reach market after Novo Nordisk's Wegovy pill. The FDA is also asking Lilly to collect thyroid cancer risk data for at least 15 years. The requests are considered routine for newly approved drugs, particularly for orforglipron, Foundayo's active ingredient, which has less safety data than older GLP-1s. Lilly must also establish registries tracking children with obesity and pregnancy outcomes.

PR Newswire
Apr 14th, 2026
Vasa Therapeutics partners with Lilly TuneLab to accelerate AI-driven CAMKII inhibitor development

Vasa Therapeutics, a clinical-stage biopharmaceutical company, has partnered with Eli Lilly to use Lilly TuneLab, an AI-enabled drug discovery platform that provides access to models trained on Lilly's proprietary research data. Vasa will use the platform to accelerate development of its CAMKII delta inhibitor, which is planned for Phase 1 clinical trials in 2027. The company's VS-041 is currently in a proof-of-mechanism trial for heart failure, whilst VS-214 is on track for first-in-human trials in 2026. The platform uses federated learning, allowing companies to access Lilly's AI models whilst maintaining data privacy. Vasa will contribute its own experimental datasets to support the platform's improvement. The company focuses on developing therapies for cardiovascular, neuromuscular and age-related disorders.

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