Associate Director, Drug Product CMC

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.  Centessa Pharmaceuticals, a wholly subsidiary of Eli Lilly and Company is advancing a portfolio of high conviction programs with strong biological validation.  Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation.  Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. Centessa ’s CMC group is currently see king a n Associate Director of Drug Product within the CMC group to support our early stage programs . The successful candidate will have a demonstrated track record of designing high performance nonclinical and clinical formulations as well as managing CROs and CDMOs. The candidate should also have hands-on experience in developing and manufacturing nonclinical and clinical small molecule drug products to support Phase I to Phase III.  This candidate will primarily lead work with various vendors and oversee nonclinical formulation development, with flexibility to support clinical drug product development, across programs to meet company deliverables and timelines .  Travel to vendors both domestically and internationally might occasionally be required .

Manage and guide external vendors, such as Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) to:   Execute physiochemical characterization and pre-formulation studies for New Chemical Entities (NCEs).     Design and develop nonclinical formulations of drug candidates (oral, subcutaneous, and intravenous) to ensure stability, bioavailability and effective drug delivery in animal models .        Design and oversee execution of nonclinical formulation stability and compatibility studies .   Support clinical formulation development of oral solid dosage forms, as needed.   Author and/or review and approve development and dose preparation protocols and reports.   Review formulation related sections of protocols and reports associated with Pharmacokinetic (PK), Pharmacodynamic (PD), and safety studies.   Represent CMC and provide nonclinical formulation, DS and DP stability, and supply guidance at internal and external cross functional team meetings.   Coordinate shipments in support of nonclinical and Clinical development supply requirements to various CDMO and CRO sites.   Assist in compiling formulation-related documentation for regulatory submissions (e.g., IND, CTA) to meet nonclinical development requirements.   Work closely and collaboratively with cross-functional CMC groups including discovery, nonclinical , clinical, project management, legal, sourcing, supply chain, quality and regulatory, as well as other CMC functions.

BS or MS in Pharmaceutical Sciences or a related scientific discipline required ; PhD strongly preferred.    7 + years of experience in small molecule formulation development, including support of nonclinical and clinical programs across oral, subcutaneous, and intravenous dosage forms.    Deep understanding of formulation