Senior Director, Process Development

Company: The American College of Radiation Oncology
Location: Cambridge
Posted on: September 14, 2020

Job Description:

Senior Director, Process Development

TCR2 Therapeutics

Cambridge, Massachusetts, United States

8 hours ago

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Description

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage immunotherapy company pioneering the development of novel T cell therapies. Our two lead cell product candidates are being studied in Phase 1/2 trials: TC-210, for solid tumors and TC-110 for hematological malignancies. Our research efforts focus on broadening our pipeline with a series of next-generation enhancements that may further improve clinical outcomes. We are headquartered in Cambridge, Massachusetts and have a clinical manufacturing facility in Stevenage, UK.

The position represents a key leadership position within the company and an excellent opportunity for career development in a fast-paced and highly collaborative environment. The individual will work closely with the manufacturing, clinical and discovery teams through all stages of clinical development.

The successful candidate will be expected to play an integral role in the development and translation of the TRuC^TM T cell platform. Specifically, the successful candidate will drive internal innovation and development of lentiviral and T cell manufacturing platforms and manage the technology transfer to GMP facilities as the programs develop. The candidate will be expected to grow and manage a cutting-edge team that will catalyze the growth of the TCR^2 platform.

Responsibilities:

* Manage lentiviral process development for pre-clinical and clinical candidates and optimize manufacturing processes for both in-house and tech transfer needs.

* Lead process development strategy and execution for gene-edited ex-vivo cell therapy products based on TRuC T cells for rapid transition of early-stage candidates into the clinic.

* Partner closely with the research team to guide process development program to ensure a streamlined and feasible product development transition.

* Manage technology transfer strategy, protocol development and establish acceptance specifications for transition to GMP facilities for all CMC activities with ability to travel for in-person and in-plant interactions.

* Provide oversight and technical support to the clinical manufacturing programs.

* Define and build an effective team to oversee process development/transfer and in-house manufacturing oversight through personal leadership, and direct reports.

* Author and review CMC content for IND submissions for clinical trials.

* Collaborate with other departments to identify efficiencies needed to meet critical corporate objectives, encompassing the area of viral vector and engineered T cell manufacturing.

* Define departmental goals and manage experimental programs to align with corporate goals.

* Determine and manage departmental yearly budget.

* Influence through effective communication, respectful challenge, and persuasion across the research organization.

Requirements

Requirements:

* Ph.D. in Cell Biology, Immunology or Virology is preferred.

* A minimum of 10-12 years post-graduate experience in an industrial setting.

* Demonstrated skills in building teams and executing on projects in a timely manner.

* Proven track record in leading pre-clinical stage programs and cross-functional teams through to successful INDs.

* Biotech experience is strongly preferred with a focus on cell and gene therapy, virology or biologics.

* Previous experience with development and manufacture of viral vectors and engineered T cells is strongly preferred.

* Ability to adapt and thrive in a dynamic and entrepreneurial early-stage environment.

* Superior personnel management and organizational skills.

* A scientifically motivated self-starter, capable of independently conceiving, conducting, and critically analyzing his/her own work with minimal supervision.

* A strong presenter and communicator, with the ability to work in a fast-paced and team-oriented environment.

Job Information

* Job ID: 54650032

* Location:

Cambridge, Massachusetts, United States

* Position Title: Senior Director, Process Development

* Company Name: TCR2 Therapeutics

* Job Function: Oncology,

Process Development

* Job Type: Full-Time * Ph.D. in Cell Biology, Immunology or Virology is preferred.

* A minimum of 10-12 years post-graduate experience in an industrial setting.

* Demonstrated skills in building teams and executing on projects in a timely manner.

* Proven track record in leading pre-clinical stage programs and cross-functional teams through to successful INDs.

* Biotech experience is strongly preferred with a focus on cell and gene therapy, virology or biologics.

* Previous experience with development and manufacture of viral vectors and engineered T cells is strongly preferred.

* Ability to adapt and thrive in a dynamic and entrepreneurial early-stage environment.

* Superior personnel management and organizational skills.

* A scientifically motivated self-starter, capable of independently conceiving, conducting, and critically analyzing his/her own work with minimal supervision.

* A strong presenter and communicator, with the ability to work in a fast-paced and team-oriented environment.

Keywords: The American College of Radiation Oncology, Cambridge , Senior Director, Process Development, Other , Cambridge, Massachusetts