Engineer, Packaging Development Distribution – Eli Lilly – Indianapolis, IN, USA
DDR&D supports the design, development, and commercialization of medical devices and owns the development and qualification of drug substance (API) and drug product packaging components and container closure systems. The Packaging Development Engineer has the responsibility of defining drug product shipping and distribution requirements and developing solutions for Lilly’s new chemical and biological entities, with primary focus on cold chain. This role functions in a development setting and is focused on supporting clinical trial (CT) material shipping, planning and executing shipping studies to generate robust data package in support of marketing applications, and implementation of commercial product shipping and distribution through integrated technical transfer. This position leads a cross functional team within CMC to develop shipping strategy for finished drug products and devices, bulk drug products, and active pharmaceutical ingredients (API). In addition, the position works with key partners in commercial organizations, include manufacturing sites, distribution centers, global logistics, and product launch team, to support commercial shipping process development and implementation.
Technical and Project Leadership
- Maintain close partnership with key development scientists, quality and business representatives to develop distribution control strategies and integrate shipping study deliverables into mainstream product development for bioproducts, including drug substances and drug products.
- Influence relevant scientists within CMC to design shipping studies incorporating product quality requirements and regulatory expectations. Oversee and coordinate completion of the studies throughout the product development phases.
- Provide robust development data package to demonstrate product robustness against shipping hazards (temperature, shock, vibration, etc). Support product marketing applications.
- Lead and/or support technology transfer activities for shipping and distribution process development and implementation at manufacturing and distribution sites. Develop networking relationships with internal and external business partners’ e.g. corporate engineering, equipment suppliers, contract manufacturing organizations, etc.
Shipping & Distribution Qualification
- Qualify shipping components and systems (shipping container, coolers, etc) for pipeline products. Ensure work products are compliant with applicable standards (e.g. USP, EP, JP, CFR, ASTM, ISTA).
- Develop specifications and drawings. Interface with CT Ops, vendors, procurement, incoming QC to implement the components in support of clinical trial material shipping needs.
- Understand product requirements and measurement challenges; incorporate the requirements into development studies.
- Participate in the corporate procurement strategy for packaging components.
Packaging and Distribution Regulatory
- Stay abreast of industry and regulatory trends and incorporate learning into engineering practices.
- Understand and apply packaging laws and guidance.
- Write technical reports, development history reports, and applicable sections of regulatory submissions
- Evaluate new technologies for use in pharmaceutical drug product shipping and distribution.
- Support the selection and implementation of new technology solutions for the continuous improvement and optimization of existing shipping processes and components. Identify opportunities to improve cost, cycle time, and compliance.
- Address cold chain, shipping and distribution development challenges through experimental design, execution and reporting.
- Bachelors degree in engineering or science
- 2-3 years engineering experience required in pharmaceutical product, medical device or food industry development, shipping, and distribution.
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
- Experience with cold chain distribution of biologics (products and drug substances) is highly desirable.
- Excellent leadership, interpersonal, and oral/written communication skills are required; Individual must be able to respond to changing priorities and short lead times
- Able to identify problems and work toward solutions
- Able to influence without direct authority
- Demonstrated attention to details and have excellent organization skills.
- Day Shift
- Location is in Indianapolis, IN at Lilly Technology Center – North.
- Estimated US and OUS travel, 0-20%.
- Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.