Associate Director, Drug Substance CMC

Centessa Pharmaceuticals, LLC•Boston, MA

12h•$185,000 - $200,000•Onsite

About The Position

Centessa Pharmaceuticals plc is a new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data-driven decision-making led by subject matter experts. Centessa is advancing a portfolio of high-conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data-driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. 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.

Requirements

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 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.

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.