Director/Senior Director, Cell Process and Engineering

Company Background
Catamaran Bio is developing novel, off-the-shelf CAR-NK cell therapies designed to treat a broad range of cancers, including solid tumors. Our proprietary capabilities enable us to harness the natural cancer-fighting properties of NK cells and enhance and tailor their effectiveness with the power of synthetic biology and innovative non-viral cell engineering. We are using our TAILWIND™ Platform, an integrated suite of technologies, to specifically address the end-to-end methods of engineering, processing and manufacturing NK cells and rapidly advance our pipeline of CAR-NK cell therapy programs. Catamaran is backed by leading financial and corporate investors, including SV Health Investors, Sofinnova Partners, Lightstone Ventures, Takeda Ventures and Astellas Venture Management.

Job Summary
Catamaran Bio is seeking a highly motivated, experienced leader with demonstrated success in process development, clinical and commercial manufacturing of cell therapies to lead the development of research and clinical process for the engineering and scale up of chimeric antigen receptor engineered Natural Killer (CAR-NK) cell therapies. This position reports to the Chief Scientific Officer and oversees cell process, cell engineering and analytical development functions. The role will encompass cross-functional leadership across our internal research and development teams and with external academic and industry partners. This position is an exciting opportunity to be a key part of a dynamic start-up environment and contribute to developing safe and effective allogeneic cell therapy products for cancer patients.

Job Responsibilities
The ideal candidate would have expertise in the development of clinical and commercial manufacturing processes for cell therapy products, guiding internal cell process, cell engineering and analytical development teams.  The candidate will also be responsible for tech transfer, oversight of external manufacturing and managing relationships with CDMOs. The candidate should have experience in working seamlessly with research, regulatory and clinical teams to accelerate the clinical entry of cell therapy products.

  • Guide cell therapy process research to develop end-to-end solutions, with specific focus on cell expansion and cryopreservation to support allogeneic, off the shelf cell therapy products. Identify and implement solutions to address technical challenges in the manufacturing process to support short- and long-term manufacturing needs.
  • Champion the development of non-viral NK cell engineering using Transposon technology for research, clinical and commercial use. Constantly innovate to maintain Catamaran’s leading position in non-viral NK cell engineering
  • Develop and implement analytical capabilities to characterize impact of process changes on NK cell phenotype and collaborate with Research to develop an understanding of NK cell phenotype-cell function relationships
  • Support supply of materials including plasmids and transposase enzyme, viral vectors, engineered cells and others for research, non-clinical, analytical development and technology transfer activities
  • Identify and vet CDMOs for external manufacturing of clinical drug product and critical raw materials under GMP, in coordination with the Business team
  • Develop, tech transfer and implement cGMP manufacturing processes for CAR-NK cell therapy products meeting quality targets, and regulatory requirements
  • Develop, along with CDMOs, a supply chain for all necessary GMP materials for manufacturing and testing of drug product
  • Build, coach, mentor and guide process development, cell engineering and analytical development functions to become high performing teams and to work closely with CDMOs
  • Develop and maintain budgets in collaboration with finance and program management
  • Author and review technical and scientific documents and take responsibility of CMC section of regulatory documents. Take responsibility for study protocols and reports, validation documents, SOPs, and test methods.
  • Establish strong relationships and collaborate closely across R&D organization within Catamaran, external CDMOs, and academic and commercial partners

Education, Experience and Qualifications

  • PhD/MS/BS in a relevant discipline (chemical engineering, biomolecular engineering, biotechnology or relevant field) with minimum 15 years experience, including 10 years direct experience in cell therapy process research and development (Title will be commensurate with experience)
  • Demonstrated track record with process development supporting early and late cell therapy manufacturing.
  • Experience with and technology transfer to CDMOs and external manufacturing oversight
  • Subject matter expertise in mammalian cell culture and related aspects such as cell metabolism/media optimization, engineering fundamentals on cell culture scale-up/down, cell biology/physiology
  • Prior experience with NK-cells and NK cell engineering is highly desirable
  • Familiar with product characterization methods relevant to immune cell-based product (e.g. flow cytometry, T-cell phenotyping, cell function characterization assays, PCR / qPCR, ELISA, and western blot) and/or viral vector manufacturing
  • Familiar with FDA and EMA guidance documents relevant to gene and cell therapy. Experience authoring CMC sections of regulatory documents (IND/BLA) and engaging regulatory authorities.
  • Strong working knowledge of cGMP and quality systems requirements.
  • Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities.
  • Demonstrated leadership skills and the ability to collaborate with and effectively influence others.
  • Prior experience managing functional teams and representing function in CMC teams

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Catamaran Bio is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.