Senior Director, Regulatory CMC (New Jersey)

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company focused on the development of cell therapies for a broad range of cancers.

Tessa’s clinical pipeline derives from  two innovative cell therapy platforms; CD30 Chimeric Antigen Receptors (CD30-CARs) and Virus-Specific T cells (VSTs). Our lead candidate comprises autologous CD30 CAR-T cell therapy targeting classical Hodgkin lymphoma (cHL) and CD30+ non-Hodgkin lymphomas.

Tessa is also developing a novel, allogeneic platform technology, as a new approach to traditional cell therapy. By combining the unique properties CD30-CARs and VSTs, the platform holds potential for the creation of next-generation off-the-shelf cell therapies against a variety of hematologic malignancies and solid tumors.

Tessa’s state-of-the-art GMP cell therapy manufacturing facility will open in early 2021, and will substantially enhance in-house production capabilities. Tessa is focused on rapidly and reliably providing safe, effective treatment options for patients.

Job Position
Senior Director, Regulatory CMC

Responsibilities

  • In this leadership role, defines Global Regulatory CMC strategies, deliverables, resource requirement, budgets, and timelines to support product development milestones, from preclinical studies, regulatory filings to support clinical development and registration, to commercialization, and product life cycle management.
  • Stays current with global regulatory requirements and new technologies/methodologies in cell and gene related CMC areas that may have regulatory consequences.
  • Interacts with regulatory authorities through conferences and regulatory filings/meetings, and anticipates regulatory changes and develops proactive strategy accordingly
  • Responsible for supporting and reviewing the CMC sections in regulatory submissions including both pre-approval and post approval submissions such as IND, NDA/BLA, amendments/supplements, annual reports, product characterization study reports, comparability protocols and reports, etc.
  • Provides clear and robust regulatory recommendations for facilitating CMC strategies and execution plans in assisting product development teams
  • Anticipates regulatory CMC changes and develops proactive strategy accordingly
  • Coaches and develops a highly effective and scientifically strong team

Requirements

  • PhD or Master in Life Science (e.g. Immunology, Biochemistry, Biotechnology, Biology) or equivalent
  • Minimum of 10 -15 years in the pharmaceutical industry, with a minimum of 8 years CMC regulatory (biologics preferred) experience.
  • Cell therapy experience with global CMC regulations and regulatory submissions strongly preferred.
  • Excellent working knowledge/experience in regulatory submission and approval processes for cell and gene therapies and product life cycle management and proven practical knowledge of and ability to deal with complex CMC regulatory issues and requirements
  • Proficient with other international regulations, including ICH guidelines
  • Excellent communication and writing skills