Director, Process Chemistry, CMC Small Molecule

Associate Director/Director, Drug Product, CMC

COMPANY:

Centessa Pharmaceuticals plc (Nasdaq: CNTA) 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 companies are 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.

SUMMARY:

Centessa is seeking a 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.

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. Responsible for review, approval and issuance of manufacturing batch records.
• Work with CRO/CDMOs and expert consultants to address process chemistry challenges and develop robust manufacturing processes that are scalable, safe and cost-effective.
• Support contractor sites with active telecon 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 critically review technical reports, tech transfer packages, and GMP production records as well as CMC sections regulatory related documentation (i.e. 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 (as needed, if applicable).
• Work collaboratively with Analytical, Formulation, Project Management, CMC consultants and Quality (GCP/GxP), Regulatory, Toxicology, DMPK, Clinical and pre-Clinical, as well as with external CRO/CDMO counterparts.
• Build and maintain strong relationships with stakeholders; proactively seek buy-in and providing on-going support to address business needs. Escalate and cascade information as needed with discretion.

QUALIFICATIONS:

• Significant demonstrated 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 – written, verbal, telecon setting demeanor.
• Must be willing to travel both domestically and internationally.

EXPERIENCE:

• Ph.D. in organic chemistry with at least 8 years, MS degree with 12 years and BS degree in chemistry with 15 years of industry experience in small molecule drug development and manufacturing in pharma/biotech industry.
• Extensive experience in process chemistry development, scale-up, tech transfer and process characterizations, as well as deep understanding of GMP/GLP regulations.
• Requires a strong understanding of managing groups, CDMOs and other vendors.

POSITION: Full-Time, Exempt, Flexibility for Remote Work and travel

EEOC Statement: Centessa Pharmaceuticals 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. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.