Join Our Team

Director/Senior Director, Process Development (Viral Vector)

Bedford, MA

Our Opportunity…

We’re looking for a highly motivated leader with a strong background in late-stage viral vector/cell therapy process development to help drive the development of novel engineered tumor infiltrating lymphocyte (TIL) products in our pipeline targeting cancer.

As part of our Technical Development, Manufacturing, and Quality (TDMQ) department you will help strategize and direct the work of a highly collaborative process development team that will encompass late-stage development activities appropriate for pivotal and post-pivotal stages to enable commercialization of our lead program cytoTIL15. This position is based in our Bedford, MA office.

This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.

You Will…

• Be a key group leader within TDMQ in establishing and implementing the department’s goals, determining timelines, and managing priorities and resources.
• Contribute your expertise and strategic thinking to drive the late-stage development of clinical/commercial manufacturing processes for viral vectors and associated cell lines/banks and other critical materials, including process characterization and comparability activities.
• Lead viral vector and critical materials related tech transfer to CDMOs.
• Author and review CMC module 3 sections in regulatory filings inclusive of IND(s), IND amendments, and commercial applications (BLA, MAA etc.)
• Drive the design and execution of experiments for development of the cGMP manufacturing process and associated process controls for clinical supply of viral vectors and associated cell lines/banks and critical materials meeting yield and quality targets.
• Direct the evaluation of novel biological platforms and manufacturing technologies to address current technical challenges and identify innovative approaches for the generation of viral vectors and associated cell lines/banks, and critical materials.
• Author and review technical and scientific documents including but not limited to study protocols and reports, validation documents, SOPs etc.
• Cultivate a strong and engaged team and mentor team members on experiment design, data analysis with appropriate scientific rigor, and proper documentation in lab notebooks and other adopted document systems.
• Enable your team to supply development materials (viral vector, cell lines) to support research/non-clinical studies, analytical development, and CDMO tech transfer activities.
• Lead key technology transfer document preparation, technology transfer & implementation of the process, and serve as the technical point of contact for the process development function in assigned projects.
• Establish strong relationships and collaborate closely with internal stakeholders (MSAT, quality, regulatory, project management, and research).

You Bring…

Qualifications

• MS with >10 years or PhD with >8 years industry experience in a relevant discipline (chemical engineering, biomolecular engineering, biotechnology, or relevant field.
• Deep subject matter expertise in mammalian cell culture and viral vectors with experience in driving cell line development, banking, and manufacturing of viral vectors (retroviral/ lentiviral vectors, AAV vectors).
• Proven experience with late-stage development activities such as process characterization, comparability activities, and product characterization relevant to viral vectors and cell therapy products.
• Proven experience in technology transfer to CDMOs and external manufacturing.
• Expert knowledge of cGMP and quality systems requirements.
• Deep familiarity with FDA and EMA guidance documents relevant to viral vectors and cell lines.
• Prior authorship of CMC sections of regulatory documents (IND/BLA) and experience in engaging with regulatory authorities.
• A leadership style orientated to high standards and support to succeed and grow. You engage input of team members in problem solving and decision making and encourage open honest dialogue.
• A desire and ability to work in an entrepreneurial, collaborative environment. You build healthy, productive, and high trust relationships within your function and with direct stakeholders, and effectively influence actions and decisions.
• A flexible and creative mindset; able to productively challenge and be challenged to generate the best ideas to advance project and company goals.
• An ability to operate and adapt in a fast paced, rapidly developing environment.
• Experience translating high level goals into plans and independently leading teams to meet objectives and timelines, adapting to changes and priorities to fulfill our mission.
• Successful experience leading and managing high performing matrixed teams.
• Excellent oral and written communication skills.

Job level will be based on overall experience and capabilities

Apply for this Job