Engineering Advisor / Sr. Advisor, Oral Products - DDCS

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 131,000 - 191,000; Full time

Benefits offered by this job

401(k) matching

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Job summary

Lilly is seeking an experienced packaging engineer to serve as a key technical resource for container closure systems and packaging across the oral drug substance and drug product portfolio. You will lead studies, qualification, and technology implementations from development through commercialization.

The role requires a strong background in packaging, filling equipment, and regulatory compliance within GMP environments.

Qualifications

• Bachelor's or Master's degree in Materials Science, Industrial Design, Packaging, or related field with 12+ years of experience.
• PhD in a relevant field is preferred with 2+ years of industry experience.
• Experience with filling equipment and GMP packaging environments.

Responsibilities

• Lead design, characterization, and qualification of packaging components and container closure systems for API/product.
• Develop packaging component specifications and testing methods.
• Lead technology evaluations for packaging and filling improvements.
• Own risk assessments for components, systems, and processes.
• Collaborate with cross-functional stakeholders from clinical to commercial.

Skills

Packaging knowledge

Quality mindset

Interdisciplinary collaboration

Regulatory awareness

Education

Bachelor's or Master's degree in Materials Science, Industrial Design, Packaging, or related field

PhD in a relevant field (preferred)

Tools

Filling equipment experience

Packaging line equipment

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.

Organization Overview:

The Delivery, Device and Connected Solutions (DDCS) organization at Eli Lilly designs, develops, and commercializes drug delivery systems, devices, and packaging that bring medicines to patients around the world. This role sits on the Oral Products Packaging team, which develops container closure systems and packaging solutions for Lilly's oral drug substance (API) and drug product portfolio, including both bulk and consumer packaging configurations, from early development through commercialization.

Position Overview:

We're looking for an experienced packaging engineer to serve as a key technical resource for container closure systems and packaging solutions across our oral drug substance (API) and drug product portfolio, spanning early development through commercialization. In addition to leading core molecule packaging work, this person will build deep expertise in filling and packaging equipment, including equipment trials, troubleshooting, and process characterization.

Key Responsibilities:

Technical Leadership & Execution

• Provide technical leadership and serve as a key resource for the design, characterization, and qualification of packaging components and container closure systems for oral drug substance (API) and drug product, including bulk and consumer packaging configurations.
• Design and lead studies to develop packaging component specifications and incoming testing methods.
• Build deep expertise in filling and packaging equipment, including equipment trials, troubleshooting, and process characterization.
• Lead the evaluation, development, and implementation of new packaging or filling technology solutions for continuous improvement and to meet project milestones.
• Lead risk assessments on components, systems, suppliers, product distribution, and/or processes.

Cross-Functional Collaboration

• Work closely with internal and external stakeholders to enable project progression from clinical development through commercialization.
• Represent DDCS in project team meetings to communicate packaging strategy, component and system properties, risks, timing, and cost.
• Evaluate and communicate the impact of supplier change notifications on API and drug product packaging and regulatory commitments.
• Author and provide technical review of critical packaging documentation, including technical reports and regulatory submission content.
• May represent the department in interactions with internal or external committees, conference presentations, or publications.

Compliance & Right to Operate

• Stay abreast of regulatory and compendial requirements for packaging components and systems.
• Lead technical transfer activities to enable clinical delivery and commercial manufacturing (internal/external).
• Maintain the area in a state of regulatory inspection readiness.

Basic Qualifications:

• Bachelor's or Master's degree in Materials Science, Industrial Design, Packaging, or a related field, and 12+ years of relevant industry experience.
• Familiarity with filling equipment and/or packaging line equipment (e.g., bottle filling, blister line).
• Prior exposure to oral solid dose packaging (bottles, blisters, desiccants, closures).
• Demonstrated quality mindset and ability to influence across an interdisciplinary team.
• Strong interpersonal and communication skills with the ability to partner with and share information with internal and external stakeholders

Preferred Qualifications:

• PhD in a relevant field with 2+ years of industry related experience
• Hands-on experience with packaging or filling equipment in a GMP environment.

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 (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

$130,500 - $191,400

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
• 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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