Associate Director, Drug Substance CMC

Description of Role

Centessa is seeking an Associate Director, Small Molecule Drug Substance Process Chemistry. The successful candidate will work closely with their management in directing CDMOs to develop and implement strategies to deliver advanced chemical intermediates and active pharmaceutical ingredients for use in research, GLP and cGMP studies. This individual will work with several internal departments and third-party procurement and distribution providers to align objectives and drive decision-making related to process chemistry and manufacturing. This person will drive the execution of assigned process chemistry activities of Centessa’s small molecule pipeline. Travel to vendors both domestically and internationally may be required.

Key Responsibilities

• Direct CDMO team(s) in manufacturing of advanced chemical intermediates and APIs for GLP studies as well as early and late stage clinical studies.
• Review, approve and issue manufacturing batch records.
• Collaborate with CRO/CDMOs and expert consultants to address process chemistry challenges and develop manufacturing processes that are scalable, safe and cost-effective.
• Support contractor sites via meeting updates, remote and on-site involvement pertaining to OOS/OOT, investigations/deviations, and other pertinent documentation. In addition, provide on-site presence during active manufacturing campaigns, as needed.
• Prepare presentation materials and clearly communicate progress, challenges and potential risk in API manufacturing to management in real time or weekly basis, as needed.
• Author and review technical reports, tech transfer packages, and GMP production records as well as CMC sections regulatory related documentation (ie. INDs) submission, and any documents related to intellectual property.
• Assist with new vendor assessment and selection by providing technical review of CDMO resources, capacities, and capabilities as appropriate for development needs.
• Aid with plans for technology transfers of drug substances from one supplier to new suppliers.
• Build and maintain strong relationships with internal and external stakeholders; proactively seek buy-in and provide on-going support to address business needs.
• Escalate and cascade information as needed with discretion.

Qualifications

• PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline or MS with extensive relevant biotech/pharmaceutical industry experience
• 10+ years of experience in biotech/pharmaceutical industry in small molecules, working in early to late development (pre-clinical to phase 3)
• Extensive experience in process chemistry development, scale-up, tech transfer and process characterizations, as well as deep understanding of GMP/GLP regulations.
• Demonstrated experience with managing project teams, CDMOs and other vendors.
• Proven expertise in process chemistry and early and late stages API manufacturing and ability to coordinate CDMO activities in the development and commercialization of pharmaceutical products.
• Thorough understanding of cGMP requirements for pharmaceutical products. Ability to work
• Ability to work independently in a fast-paced dynamic environment with multiple projects.
• Strong analytical, organizational and decision-making skills.
• Excellent communication skills, both written, verbal
• Must be willing to travel both domestically and internationally approximately 15% - 20% of the time.

Compensation

The annual base salary range for this position is $185,000.00 to $200,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa 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 Associate Director, Drug Substance CMC role is based in the US, with occasional travel (15% - 20%).

POSITION: Full-Time, Exempt