Description of Role
The Director, Quality Control (contractor) 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.
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.
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 hourly range for this position is $95.00 to $120.00 per hour. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.
Contractors engaged through Centessa are employed through a third-party agency that serves as the employer of record and provides access to a comprehensive benefits package. Eligible contractors may enroll in medical plans, including PPO and EPO options, as well as dental and vision coverage after 30 days. Additional perks, such as a 401(k), wellness programs, and other discounts, may also be available to eligible contractors.
Work Location
The Director, Quality Control contractor 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.
Skills Required
- BS, MS, or PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field
- 10+ years of quality control and analytical development experience
- Experience developing strategic vision and providing tactical support for quality control programs
What We Do
Centessa Pharmaceuticals plc is a clinical-stage pharmaceutical company with a Research & Development innovation engine that aims to discover, develop and ultimately deliver impactful medicines to patients. Our programs span discovery-stage to late-stage development and cover a range of high-value indications in rare diseases and immuno-oncology. We are led by a management team with extensive R&D experience, providing direct guidance to our program teams to rapidly advance our candidates from research through all stages of development. We are headquartered in Boston, Massachusetts
