Distribution Engineer – Eli Lilly – Indianapolis, IN, USA
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
In 1992, Eli Lilly and Company established the Delivery Device business for the purpose of creating, developing, launching and continuously improving proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient centered delivery system solutions, its innovative approach to delivery platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. The Delivery and Device Research and Development (DDR&D) organization leverages many alliances in design and manufacturing to rapidly convert proprietary product concepts into products that meet the users’ needs and intended uses. This business enables almost $4.0 billion in pharmaceutical sales and is projected to double in the next 6 years.
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.
- Bachelor’s Degree in engineering or science
- 2-3 years engineering experience required in pharmaceutical product, medical device or food industry development, shipping, and/or 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.
- Experience with ISTA Testing (i.e. ISTA 3A, etc.) including shock, vibration, temperature, pressure challenges as it relates to molecule stability and associated device functionally.
- Experience with ISTA cold chain ‘shipper’ qualification and monitoring program(s).
- Relevant Shock/Vibration Table procurement, installation and qualification including temperature and pressure control.
- 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