Advisor - Engineering - Drug Product - Synthetic Molecule Design and Development (SMDD)

---

Job description

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 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.

Lilly's Synthetic Molecule Design and Development (SMDD) team is involved in key development activities from pre-clinical phases through commercialization of drug substances and drug products for small molecules, synthetic oligonucleotides and peptides. Our scientists develop key technical and business solutions across the portfolio using their deep technical expertise to speed up testing of the clinical hypothesis and overall drug development. SMDD takes on this diversity of responsibilities by recognizing that an even greater diversity of talents and cultures is necessary to deliver the next generation of life changing medicines to patients!

SMDD is seeking outstanding engineering candidates to work within the process design and development team! This position presents an opportunity to work side by side with chemists, analytical chemists, formulation scientists and modelers to develop new technical solutions to accelerate our portfolio. This position will be based in Indianapolis where research is conducted in a new, state of the art development facility.

Responsibilities

Candidates must demonstrate a history of strong technical depth, scientific leadership and a willingness to promote a collaborative, team-based approach to problem solving. The responsibilities for this role include:

• Apply engineering fundamentals towards designing and optimizing continuous and batch drug product processes at lab, pilot, and manufacturing scales, including but not limited to powder feeding, powder mixing, wet and dry granulation techniques, encapsulation, tablet compaction, spray dry dispersion, hot melt extrusion, and tablet film coating.

• Design and execute experiments in a laboratory/pilot plant setting and/or leverage scale-up and process control models to ensure robust processes capable of meeting early and late phase demands.

• Develop stage-appropriate process control strategies encompassing necessary aspects such as equipment operations, automation systems, PAT, model-based predictions, and methods of data reconciliation and monitoring in real time.

• Serve as a member of integrated commercial teams responsible for the development and demonstration of modernized processes.

• Ensure compliance with regulations, guidelines, procedures, and practice governing drug product research and development.

• Collaborate closely with multifunctional organizations such as Project Management, Quality, Manufacturing, and Regulatory to execute and deliver material and information for clinical trials and regulatory submissions.

• Engineers in SMDD will be responsible for overseeing scaleup and technology transfer to manufacturing facilities within and external to Lilly through team meetings, site visits, and process monitoring.

• Foster an inclusive environment by promoting diverse thought and shared experience to deliver innovative solutions that address unmet technical needs.

• Publish and present original research externally, author internal technical documents and develop and document control strategies for new product registration applications (manufacturing process and development history portions).

Basic Requirements

• PhD in Chemical Engineering, Pharmaceutical Sciences, Materials Engineering, or related discipline.

• MSc in related fields with 7+ years of experience

• BSc in related fields with 10+ years of experience

Additional Skills/Preferences

• Experience with design, development, control and optimization of drug product manufacturing unit operations.

• Experience with modeling and simulation tools, data analytics and predictive analytics.

• Experience in continuous manufacturing within the pharmaceutical industry is preferred: Experience on technical considerations for equipment design and integration, process monitoring, integration of process analytical technologies (PAT) systems, scientific approaches on control strategy and process parameters.

• Excellent verbal communication and documentation skills.

• Demonstrate ability to effectively collaborate with multidisciplinary teams.

• Demonstrate leadership behaviors with ability to accept challenges, seek opportunities to remove obstacles, influence without authority, and lead in areas of uncertainty.

• Demonstrate outstanding teamwork/interpersonal skills.

• Demonstrate problem solving, attention to detail and result oriented behaviors in a fast-paced environment.

Additional Information

• Travel: 0 to 10%

• Position Location: Local/Onsite in Indianapolis, IN.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

<!– job description page –>