Director, External Quality Control & Stability
Role Overview
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. Centessa's 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.
The Director, External Quality Control & Stability will provide leadership and oversight for analytical testing, stability programs, specification management, and quality control activities supporting clinical and commercial development.
Full Job Posting
Overview
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. Centessa's 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.
The Director, External Quality Control & Stability will provide leadership and oversight for analytical testing, stability programs, specification management, and quality control activities supporting clinical and commercial development.
Analytical Oversight and Tactical Support
Develop and Lead analytical quality control strategy across multiple programs.
Review analytical methods, specifications, and validation activities for adequacy and collaborate on updates, as required.
Support analytical method transfer, as required
Collaborate on supplier qualification and/or remediation activities.
Stability Program Leadership
Oversee the stability program design and execution across multiple programs.
Monitor and report on stability trends and product quality attributes as required.
Ensure ongoing regulatory compliance of stability activities.
Supplier Oversight
Manage supplier ongoing relationships.
Perform routine reviews of testing results and overall quality of documentation.
Drive issue resolution to facilitate regulatory compliance.
Regulatory Support
Provide tactical support for regulatory submissions
Support health authority inspections and audits, as required.
Review analytical and stability sections within CMC filings.
Basic Qualifications
- BS/MS/PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field.
- 10+ years quality control and analytical development experience.
- Experience developing strategic vision as well as providing tactical support for quality control programs
Work Location
- The Director, External Quality Control & Stability role is a remote role based in the US.
- Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
- Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
- Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
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