Associate Director/Director, Drug Product, CMC

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 continues to expand its CMC group and currently seeks an Associate Director/Director of Drug Product within the CMC group. The successful candidate will have a demonstrated, proven track record of designing high performance nonclinical and clinical formulations as well as managing CROs and CDMOs. The candidate should also have hands-on experience in developing and manufacturing nonclinical and clinical small molecule drug products to support Phase I to Phase III.  This candidate will primarily lead work with various vendors and oversee nonclinical formulation development, with flexibility to support clinical drug product development, across programs to meet company deliverables and timelines.  Travel to vendors both domestically and internationally might occasionally be required.

KEY RESPONSIBILITIES:

• Manage and guide external vendors, such as Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) to:
  • Execute physiochemical characterization and pre-formulation studies for New Chemical Entities (NCEs).
  • Design and develop nonclinical formulations of drug candidates (oral, subcutaneous, and intravenous) to ensure stability, bioavailability and effective drug delivery in animal models.  
  • Design and oversee execution of nonclinical formulation stability and compatibility studies.
  • Support clinical formulation development of oral solid dosage forms, as needed.
• Author and/or review and approve development and dose preparation protocols and reports.
• Review formulation related sections of protocols and reports associated with Pharmacokinetic (PK), Pharmacodynamic (PD), and safety studies.
• Represent CMC and provide nonclinical formulation, DS and DP stability, and supply guidance at internal and external cross functional team meetings.
• Coordinate shipments in support of nonclinical and Clinical development supply requirements to various CDMO and CRO sites.
• Assist in compiling formulation-related documentation for regulatory submissions (e.g., IND, CTA) to meet nonclinical development requirements.
• Work closely and collaboratively with cross-functional CMC groups including discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality and regulatory, as well as other CMC functions.

QUALIFICATIONS:

• Strong organizational, analytical, and interpersonal skills.
• Ability to work independently in a fast-paced dynamic environment with multiple projects.
• Demonstrated ability to coordinate external development (CRO, CDMO, CMO) activities in the development of pharmaceutical products.
• Knowledge of cGMP requirements for pharmaceutical products.
• Strong decision-making and communication skills and resource management skills in a dynamic environment located across multiple geographies.
• Excellent organizational skills, project management skills and detail-orientated leadership approach
• Must be willing to travel both domestically and internationally as needed (5-10%).

EXPERIENCE:

• Bachelor’s degree in Pharmaceutical Sciences or a related field. MS or Ph.D is preferred.
• 5-10 years of formulation experience in various delivery forms (oral, subcutaneous, and intravenous) of small molecules supporting nonclinical and clinical formulation development.
• Demonstrated understanding of technical aspects associated with the development and manufacture of poorly soluble (BCS Class II/IV) small molecule compounds for oral, subcutaneous, and intravenous delivery.
• Familiarity with analytical characterization techniques such as HPLC/UPLC, and solid-state characterization tools, including XRPD, DSC, TGA, DVS, etc.
• A strategic thinker with strong result-orientation, and sense of urgency to deliver quality results on time and in a high ethical and professional manner.
• Excellent communication and interpersonal skills with the ability to build, sustain, and manage internal and external relationships and communicate complex issues and concepts at all levels.
• Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them.
• Resilient and able to work well in a demanding, innovative and fast paced environment.
• Strong verbal and written communications skills, ability to express oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
• Sound knowledge of pharmaceutical and engineering principles in liquid and solid dosage form development for both clinical and commercial scales.
• Strong organizational skills and attention to detail.

POSITION: Full-Time, Exempt, Remote, 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.