Senior Advisor Manufacturing Package Design

Lilly; India; Remote; INR 13,559,000 - 23,616,000; Full time

Benefits offered by this job

Bonus eligibility

401(k) plan

Pension

Vacation benefits

Medical, dental, vision coverage

Flexible benefits

Job summary

Lilly is seeking a Senior Advisor, Manufacturing Package Design to lead the design, development, and technical strategy for packaging supporting late-stage clinical and commercial drug products. You will partner with Manufacturing, Quality, Regulatory Affairs, and Supply Chain to ensure packaging meets quality and regulatory standards.

Based in the US with occasional travel, you will build and mentor a team, manage CMOs/CPOs, oversee change controls, and contribute to regulatory submissions.

Qualifications

• Bachelor's degree in packaging engineering, mechanical engineering, materials science, chemistry, life sciences, or a related field; advanced degree preferred.
• 7+ years’ experience in sponsor-side manufacturing package design with leadership of packaging programs.

Responsibilities

• Lead design, development, and technical strategy for primary and secondary packaging for late-stage clinical and commercial programs.
• Represent packaging on project teams with CMOs/CPOs and manage related relationships.
• Ensure clinical trial packaging, labeling, and forecasts align with product demand.
• Direct packaging engineering activities including design verification/validation and packaging stability studies.
• Lead technology transfer to commercial manufacturing with line trials and scale-up.
• Maintain documentation, DHFs, packaging specifications, and risk assessments per cGMP.
• Collaborate with Regulatory Affairs on packaging sections of regulatory submissions.
• Support packaging design for launch readiness and lifecycle management.
• Identify improvements for packaging processes, equipment, and vendor performance.
• Manage change controls, deviations, and CAPAs related to packaging design.
• Evaluate packaging materials and equipment with CMOs/CPOs; support supplier qualification.
• Provide packaging expertise for quality systems and procedures.
• Build and mentor a packaging design team; support regulatory inspections.

Skills

Packaging design leadership

Late-stage packaging experience

CMO/CPO relationships

cGMP knowledge

Cross-functional collaboration

CMC regulatory submissions

Education

Bachelor's degree in packaging engineering

Advanced degree preferred

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as Great Place to Work ® in 2026.

We are currently seeking an Senior Advisor, Manufacturing Package Design. This individual will lead the design, development, and technical strategy for primary and secondary packaging supporting late-stage clinical and commercial-stage drug product manufacturing. Reporting to the Vice President, CMC, this role will provide technical and strategic leadership for packaging systems, ensuring solutions meet quality, regulatory, and commercial manufacturing readiness requirements. This individual will partner cross-functionally with Manufacturing, Quality, Regulatory Affairs, and Supply Chain, as well as external Contract Manufacturing/Packaging Organizations (CMOs/CPOs), to drive packaging design, qualification, and launch readiness for late-stage development programs.

Responsibilities:

• Lead the design, development, and technical strategy for primary and secondary packaging components/systems for small molecule solid oral dosage forms (e.g., container closure systems including bottles and blisters, and blister wallet configurations where applicable) supporting late-stage clinical and commercial manufacturing programs.
• Serve as the manufacturing/CMC packaging design lead representing the company on project teams with external CMOs/CPOs; manage packaging-related technical relationships, including periodic site visits as required.
• Partner with CMC and Clinical Supply Chain to ensure proper clinical trial packaging and labeling are aligned with production forecasts and product demand
• Direct packaging engineering activities, including design verification/validation, transportation and shipping validation, stability packaging configurations and compatibility studies.
• Lead technology transfer of packaging design and processes from development/clinical scale to commercial manufacturing, including line trials, engineering runs, and scale-up activities.
• Develop and maintain technical documentation supporting packaging design (e.g., design history files, packaging specifications, risk assessments/FMEAs) in accordance with cGMP and applicable design control requirements.
• Partner with Regulatory Affairs to author and review CMC packaging sections of regulatory submissions and respond to health authority queries related to packaging.
• Collaborate with Manufacturing, Quality, Supply Chain, and Commercial teams to ensure packaging design supports launch readiness, commercial supply continuity, and product lifecycle management.
• Identify, lead, and implement continuous improvement initiatives for packaging processes, equipment, and vendor performance to achieve sustainable, scalable manufacturing performance.
• Manage packaging-related change controls, deviations, and CAPAs in collaboration with Quality; support root cause investigations related to packaging design or component performance.
• Evaluate and select packaging materials, components, and equipment in partnership with CMOs/CPOs and suppliers; support qualification of new suppliers and packaging lines.
• Provide packaging design expertise in support of the development of quality systems, processes, and procedures.
• Build, lead, and mentor a team supporting manufacturing package design activities (scope dependent on level).
• Provide subject matter expertise and support during regulatory inspections and audits related to packaging design and engineering.
• Domestic and international travel required (approximately 10–20%).

Minimum Qualifications:

• Bachelor's degree in packaging engineering, mechanical engineering, materials science, chemistry, life sciences, or a related field; advanced degree preferred.
• 7+ years’ experience in sponsor-side manufacturing package design, with demonstrated leadership of packaging design programs. Significant experience supporting late-stage clinical and/or commercial packaging programs required.
• Strong knowledge of cGMP regulations and industry standards/trends pertaining to pharmaceutical packaging design, container closure systems, and manufacturing.
• Demonstrated experience leading packaging technical strategy and design for late-stage/commercial programs, including technology transfer to commercial manufacturing.
• Experience managing relationships with CMOs/CPOs and packaging component/material suppliers.
• Working knowledge of drug substance, drug product, and packaging principles, equipment, and processes across solid dosage and/or parenteral formats.
• Experience authoring or reviewing CMC packaging sections of regulatory submissions preferred.
• Experience with combination products/device packaging preferred, as applicable.
• Strong leadership, project management, and cross-functional collaboration skills; exercises judgment within broadly defined practices and policies in determining solutions and actions.
• Demonstrated ability to identify and address packaging-related technical or quality issues that could jeopardize schedule, supply, or overall program success.

Work Location:

• The Senior Advisor, Manufacturing Package Design role is based in the US, with occasional travel.

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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

$144,000 - $250,800

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• 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.
• 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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