Senior Manager, Regulatory CMC

Company Background

Tessa Therapeutics is a clinical-stage immunotherapy company focused on the development of autologous and off-the-shelf, allogeneic therapies targeting solid tumors. Tessa’s Virus-Specific T cell (VST) platform harnesses the body’s potent anti-viral immune response and has shown compelling results in the treatment of solid tumors.

Tessa is building a portfolio of innovative, next-generation therapies by combining the qualities of VSTs with other immuno-oncology technologies. This includes a rapidly growing pipeline of clinical and pre-clinical autologous programs that target a wide range of cancers, including nasopharyngeal carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer, bladder cancer, as well as head and neck cancer. In addition, Tessa is leveraging its platform to develop an allogeneic therapy to address Epstein-Barr virus (EBV)-associated lymphomas.

Tessa has built up robust operational and supply chain capabilities to successfully deliver T cell therapy treatments to a large patient pool worldwide. Together with the Company’s academic, clinical, and commercial research partners, Tessa has created a fully-integrated approach to the treatment of cancer with immunotherapy.

Our mission is to cure cancers and save lives with our innovative and widely accessible immunotherapies. We are looking for highly motivated and enthusiastic individuals who are interested to be part of our team.

Job Position
Senior Manager, Regulatory CMC

Reports To
Vice President, Regulatory CMC

Responsibilities

  • Project Management: Act as a Regulatory Project Manager in planning, coordination and tracking CMC dossier for IND. Interact with cross-functional departments for deliverables are met according to the company’s timelines.
  • Regulatory CMC Lead: Represent Regulatory Affairs CMC perspective to teams. Provide regulatory CMC guidance on FDA and global requirements to the team. Prepare and submit high quality regulatory submissions (Module 3 IND, query response) to global health authorities in accordance with regulatory guidelines and applicable federal laws.
  • Prepares CMC sections of regulatory submissions for cell and gene therapy products in various phases of product development. Define CMC content (data and documentation) for high quality submissions.
  • Responsible for regulatory CMC review of regulatory document, reports and data for conformance with the requirements and expectations of health authorities.
  • Serve as Regulatory Affairs CMC Project Manager, liaise with cross functional departments; strategize and plan for timely registration submissions in the Unites States and other countries assigned.
  • Work closely within the Regulatory department to prepare robust regulatory applications to achieve departmental and organizational objectives.
  • Serve as Regulatory Affairs CMC lead for assigned project in deliver high quality CMC dossier suitable for registration and subsequent post-approval CMC activities.
  • Compile, review and approve CMC documents/modules for assigned marketing registration applications accordingly to regulatory requirements. Coordinate response to information request as well.
  • Work with Tech Ops team in providing regulatory CMC requirements and resolve technical issues.
  • Prepare CMC briefing package for various agency meetings.
  • Interact with FDA under the guidance of department head.
  • Maintain relevant cell gene CMC knowledge base of existing and emerging regulations, standards, or guidance and provide interpretive assistance to cross-functional teams.

Requirements

  • Minimum of bachelor’s degree in Science (e.g. Biology, Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent. Advanced Degree in Science desired.
    5-7 years of CMC experience for biologics (in manufacturing or quality discipline). A minimum of 3 years in Regulatory Affairs is required. Experience in cell/ gene therapy is preferred.
  • Proven ability to manage projects towards IND or BLA. Capable of performing independently and thinking analytically and creatively to solve problems.
  • Recent experience in preparing CMC sections of INDs/BLAs for cell and gene therapy products is required. International regulatory experience is a plus.
  • Be a team player can work across functions for achievement of shared goals in a small company setting.
  • Excellent communication and interpersonal skills required to enable optimal interactions both internally and externally.
  • Successful track record in delivering regulatory projects.
  • Solid wording knowledge of CMC requirements for biologics in development towards marketing registration in the United States.
  • Understand drug product development progress.
  • Understanding of scientific principles and capable of interpreting regulatory requirements.
  • Demonstrated project management experience and can work in a cross-functional team environment to develop, implement and deliver on project goals.
  • Strong knowledge with MS Office applications, MS Project, SharePoint and Document Management System.