Senior Director / Vice President of Process and Analytical Development
- 200 Cambridgepark Dr, Cambridge, MA 02140, USA
Together with our elite cancer immuno-therapy scientists, you will be a part of our Drug Discovery teams leading projects to apply our ACTR (Antibody Coupled T cell Receptor) technology against different cancer indications. Our teams work from early discovery through launching programs into clinical development, offering you a great experience across the stages of invention. Our nimble and interdisciplinary approach to research can help you learn how to use creativity, cooperation, and critical thinking to solve hard problems. You’ll get to know scientists following diverse career paths and see for yourself how the extraordinary successes of immune therapies are creating new chances to help cancer patients.
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
- 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
All your information will be kept confidential according to EEO guidelines.