AVP, Drug Product Development

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.

Summary:   The Synthetic Molecule Design and Development (SMDD) department within Lilly Research Labs is involved in key activities for the advancement of small molecules, peptides, and oligonucleotides from early discovery phases to commercialization. Our scientists and engineers develop innovative technical and business solutions across a portfolio of projects using their deep technical   expertise   to accelerate testing of the clinical hypothesis and overall drug development. Through recognizing the value of a hardworking, diverse, and inclusive workforce, SMDD   delivers on   these responsibilities and helps bring the next generation of life changing medicines to patients. Our team is looking for highly motivated and creative candidates who will work on the integration of early drug discovery, preclinical, and clinical activities with a focus on drug product design and development.

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. 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.

Ph.D. in chemical engineering or pharmaceutical sciences with   1 0 + years