Senior Director, Drug Product CMC

About the role

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa's lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. The OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026.

Centessa is seeking a Senior Director of Drug Product within the CMC group. The successful candidate will have a demonstrated, proven 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. Reporting to the Executive Director, CMC, this position will primarily lead work with external vendors and oversee non-clinical formulation development, with flexibility to support clinical drug product development, across programs to meet company deliverables and timelines. Travel to domestic and international vendors required.

Responsibilities

• Directly manage 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 non-clinical 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.

Qualifications

• Advanced degree in Chemistry, Pharmaceutical Sciences, or a related discipline; Ph.D. is strongly preferred.
• 10+ years of drug product/formulation development experience supporting nonclinical and clinical programs, with expertise across oral, subcutaneous, and intravenous dosage forms for small molecules.
• Deep technical expertise in the development and manufacture of poorly soluble (BCS Class II/IV) compounds, including formulation strategies for oral and parenteral delivery.
• Strong understanding of pharmaceutical sciences and engineering principles related to liquid and solid dosage form development from early-stage development through clinical and commercial manufacturing.
• Working knowledge of analytical and solid-state characterization techniques, including HPLC/UPLC, XRPD, DSC, TGA, DVS, and related methodologies.
• Experience managing external development and manufacturing partners (CROs, CDMOs, and CMOs) and a solid understanding of cGMP requirements.
• Proven ability to lead multiple complex programs in a fast-paced environment, with strong project management, prioritization, resource management, and organizational skills.
• Excellent communication, presentation, and interpersonal skills, with the ability to influence stakeholders, build productive internal and external partnerships, and communicate complex scientific concepts to diverse audiences.
• Strategic, hands-on leader with strong decision-making and problem-solving capabilities, demonstrated resilience, and a track record of delivering high-quality results with urgency and integrity.
• Willing and able to travel domestically and internationally as needed.

Pay

The anticipated wage for this position is $163,500 - $264,000. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits

Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Schedule

Full-time.