Director - Drug Product Development (SMDD)

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 35,000 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.

At Lilly, Synthetic Molecule Design and Development (SMDD) is involved in key activities related to the development of synthetic active pharmaceutical ingredients and drug products from pre-clinical phases through commercialization. Our scientists and engineers develop key technical and business solutions across the portfolio using their deep technical expertise to accelerate testing of the clinical hypothesis and overall drug development. SMDD delivers on these responsibilities by recognizing that diverse talent and cultures are vital to bring the next generation of life changing medicines to patients!

Our team is looking for candidates interested in further advancing formulation, manufacturing platform technologies and commercialization of solid drug products. The candidate will collaborate with other development scientists/engineers and manufacturing groups to provide technical leadership in the design and implementation of formulation and manufacturing technology platforms, with special focus on continuous manufacturing. The position presents possibilities to work across multiple subject areas, sites, and networks! Top candidates for this position will be encouraged to:

Responsibilities:

• Apply experience in both batch and continuous solid drug product manufacturing unit operations to accelerate product development.

• Understand the interaction between raw material properties and processability as well as how unit operations can be used to improve manufacturability.

• Build comprehensive material and manufacturing process risk assessments that will guide formulation selection, development, and experimental work-plans.

• Improve product design through definition of drug product critical quality attributes (CQAs).

• Drive the implementation of new platforms such as continuous manufacturing, process analytical technologies (PAT), and modeling and simulation tools.

• Design robust and globally acceptable manufacturing process control strategies as well as partner with manufacturing teams to transfer those control strategies.

• Lead short and long-term development activities including prioritization of technical agendas and timelines.

• Partner with multi-functional teams such as Product Delivery, Project Management, Quality, Manufacturing, and Regulatory to execute and deliver material and information for clinical trials and regulatory submissions.

• Engage and influence the external environment as well as demonstrate the ability to recognize and adopt external innovation across Lilly’s drug product portfolio.

• Embrace learning agility to apply fundamental knowledge/experience to novel problem statements in order to accelerate drug product development.

• Lead the development of regulatory strategies including authorship of INDs, NDAs, and response to regulatory inquiries.

• Embrace diverse thought, background, and experience to deliver creative solutions that address unmet technical needs.

Basic Qualifications:

• Ph.D. in chemical engineering, pharmaceutical sciences or a related field with 5+ years of experience or B.S. or M.S. with 10+ years of demonstrated equivalent experience in a related field of expertise

Additional Skills/Preferences:

• Experience with developing solid drug product formulations, manufacturing processes and technical transfer of processes into manufacturing

• Sound fundamentals and understanding of biopharmaceutics

• Awareness of non-standard (e.g. modified release, peptide) oral drug delivery landscape

• Experience in continuous manufacturing

• Experience in developing pharmaceutical dosage forms as a formulation scientist or process engineer

• Knowledge and experience with management of a technical project

• Demonstrated leadership capabilities in a team environment

• Experience supervising or guiding the work of others

• Strong communication and a sustained tendency for collaboration

• Good verbal and written communication skills

• Ability to prioritize multiple activities and handle ambiguity

• Demonstrated initiative, risk-taking, and ability to drive and accept change

• Engagement and awareness of the external scientific and regulatory landscape

Additional Information:

• Location: Indianapolis, IN

• Some travel necessary

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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law). 

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