Senior Director / Vice President of Process and Analytical Development

  • 200 Cambridgepark Dr, Cambridge, MA 02140, USA
  • Full-time

Company Description

Unum Therapeutics is a clinical-stage biopharmaceutical company focused on developing curative cell therapies to treat a broad range of cancer patients. Unum’s novel proprietary technologies include Antibody-Coupled T cell Receptor (ACTR), an autologous engineered T-cell therapy that combines the cell-killing ability of T cells and the tumor-targeting ability of co-administered antibodies to exert potent antitumor immune responses, and Bolt-On Chimeric Receptor (BOXR), designed to improve the functionality of engineered T cells by incorporating a “bolt-on” transgene to overcome resistance of the solid tumor microenvironment to T cell attack. Unum has multiple programs in Phase 1 clinical testing and preclinical testing, including; ACTR707 used in combination with trastuzumab in adult patients with HER2+ advanced cancer and used in combination with rituximab in adult patients with r/r NHL; and BOXR1030 expressing the GOT2 transgene and targeting GPC3+ solid tumor cancers.

Unum’s BOXR1030, the first preclinical product candidate to emerge from the BOXR platform, is composed of a GPC3 targeted CAR and a “bolt-on” enzyme called glutamic-oxaloacetic transaminase 2 (GOT2) that aims to improve T cell function in the solid tumor microenvironment through enhanced metabolism. GOT2 plays a central metabolic role by linking multiple pathways involved in biosynthesis and cellular energy production.

Unum Therapeutics is headquartered in Cambridge, MA.

Job Description

Unum Therapeutics seeks an experienced professional to lead the Process and Analytical Development organization and drive the strategy for our early- and late-stage clinical development programs. In this role you will direct a highly-functioning technical department tasked with developing processes and methods for our platform that includes retroviral / lentiviral vectors and engineered T-cell products—Antibody Coupled T cell Receptor (ACTR) and Bolt-On Chimeric Receptor (BOXR). There is great opportunity to lead and evolve this function to support a broad portfolio of therapies. We are interested in candidates with a proven track-record of technical excellence and product development and are looking for an authentic leader with a dedicated focus on developing organizations and growing future leaders. The successful candidate will integrate activities and perspectives across functions to deliver therapies that transform the lives of patients.

  • Develop and mentor a high-performing team of scientists
  • Evolve the functional strategy for early stage products, rapid transition of early-stage candidates into the clinic, and evolution of next generation and novel platform elements into the regulated environment
  • Develop and execute strategy for analytical development and product characterization to support registrational trials
  • Identify risks and drive continuous improvement in the manufacturing processes through technological innovation, operational improvement, and alignment with regulatory and commercial manufacturing requirements
  • Manage the functional component of business planning and budget accountability for the function
  • Work with CMC, Quality, Regulatory, Clinical, and Program Management functions and to align process and analytical development strategy with program, portfolio, and corporate goals
  • Build processes and relationships with external development, testing, and manufacturing organizations environment
  • Author, review, and approve CMC documentation for regulatory filings as well as attending pertinent regulatory meetings as the functional owner

Qualifications

  • 10+ years relevant industry experience
  • A Ph.D. in engineering or life sciences preferred
  • Experience with tech transfer and technical support of external manufacturing providers, partners, and/or academic collaborationsPrior experience in vector or cell processing functions in the cell and gene therapy field is desired
  • Demonstrated ability to successfully manage biologics programs through late stage clinical development is required
  • Proven track-record of technical excellence and product development
  • Strong interpersonal skills with the ability to motivate others, influence, and negotiate conflict situations
  • A keen ability and desire to grow an organization, mentor our next level leaders, and help manage the dynamics of change
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
  • Ability to navigate and be successful in a fast-paced, highly-matrixed work environment

Additional Information

All your information will be kept confidential according to EEO guidelines.