(Sr.) Director, CMC



COMPANY:

Centessa Pharmaceuticals plc (Nasdaq: CNTA) 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.

SUMMARY:

As we continue to grow, we are seeking a (Sr) Director, CMC. The (Sr.) Director, CMC will assist in defining strategy and assist (when necessary) with execution for our companies working with our seven large molecule programs (antibodies and peptide/protein expression).  The (Sr.) Director will have the knowledge of CMC processes (and regulatory requirements) and have a solid understanding of the duration, timing and execution of required activities.  The objective is to guide and assist our programs in order of execution such that preventable delays waiting for CMC deliverables are avoided.

RESPONSIBILITIES:

  • Identification and resolution of technical challenges in the areas of drug substance process development and manufacturing, drug product formulation development, drug product process development, manufacturing, and packaging, analytical method development, and technology transfer
  • Creation and execution of CMC development plans for new products; ability to manage regulatory submissions and project manage these submissions with the Technical Operations team and associated CMOs
  • Assistance in the creation and execution of process (drug substance and drug product) and analytical method validation plans
  • Coordination with supply chain and clinical operations groups for production of clinical trial materials
  • Assistance in batch record review, as required
  • Assistance in deviation investigations, as required (assess regulatory impact for deviations and change controls)
  • Assistance in the writing, preparation, and review of regulatory documentation
  • Assistance in due diligence technical assessments of potential new products

QUALIFICATIONS:

  • Thorough understanding of cGMP requirements for pharmaceutical products
  • Strong organizational, analytical and interpersonal skills
  • Ability to work independently in a fast-paced dynamic environment with multiple projects
  • Demonstrated ability to coordinate CMO activities in the development and commercialization of pharmaceutical products
  • Strong decision-making and analytical skills
  • Excellent organizational skills, project management skills and detail-orientated leadership approach

EXPERIENCE:

  • MS or Ph.D. in chemistry, pharmaceutical sciences, or related field preferred
  • 5-7 years of direct experience with pharmaceutical product development
  • Experience in sterile fill/finish of drug product for clinical studies
  • Experience in Supply Chain requirements and timing (packaging/labeling is a plus but not mandatory as well as a deep understanding of GMP regulations)
  • Must have experience working with CMOs and a solid knowledge of analytical method development/validation

POSITION: Full-Time, Exempt

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.


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