Director, External Quality Control & Stability

Centessa; Boston, Northern (MA, KY); Hybrid; USD 150,000 - 210,000; Part time

Benefits offered by this job

401(k)

Medical insurance

Dental insurance

Vision insurance

Life insurance

Paid time off

Wellness program

Job summary

Centessa Pharmaceuticals, based in the US, seeks a Director of External Quality Control & Stability to lead analytical testing, stability programs, and specification management supporting clinical and commercial development.

The role requires 10+ years in quality control/analytical development, with a strategic vision for quality control and a track record of regulatory-facing work. This remote US position offers a competitive base salary and comprehensive benefits.

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.

Responsibilities

• Develop and lead analytical quality control strategy across multiple programs.
• Review analytical methods, specifications, and validation activities for adequacy and collaborate on updates.
• Support analytical method transfer and supplier qualification activities.
• Oversee the stability program design and execution across multiple programs.
• Monitor and report on stability trends and product quality attributes.
• Ensure regulatory compliance of stability activities and documentation.
• Provide tactical support for regulatory submissions and inspections.

Skills

Analytical QC strategy

Method transfer

Stability leadership

Regulatory compliance

Regulatory submissions

Audits & inspections

Education

BS in Chemistry

MS in Analytical Chemistry

PhD in Pharmaceutical Sciences

Job description

Director, External Quality Control & Stability

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.

Description of Role

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.

Key Responsibilities

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.
• 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.

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

Compensation

The annual base salary range for this position is $150,000.00 to $210,000.00. Individual compensation within this range will be determined based on a variety of factors, including location, qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. The Company also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Director, External Quality Control & Stability role is a remote role based in the US .

POSITION: Temporary, non-exempt

EEOC Statement: Centessa Pharmaceuticals, a wholly owned subdisary of Eli Lilly and Company believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.