Join Our Team

Director, Process Development

Bedford, MA

Our Opportunity…

We’re looking for a highly motivated leader with a strong background in 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 and Manufacturing (TD&M) department you will direct a highly collaborative process development team working to achieve Obsidian’s vision by translating innovative science into medical breakthroughs for patients, starting with our lead program cytoTIL15 engineered to make TILs more effective for more patients.

This is a unique opportunity in a well-funded early-stage company with blue chip investors, field-leading advisors, and a highly experienced team. You will 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 TD&M in establishing and implementing the department’s goals, determining timelines, and managing priorities and resources
• Contribute your expertise and strategic thinking to drive the development of clinical/commercial manufacturing processes for viral vectors and associated cell lines/banks, and/or engineered cell therapy products, tech transfer to CDMOs, oversight of external manufacturing, and regulatory filings
• 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/or engineered cell therapy products 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/or engineered cell therapy products.
• Author and review technical and scientific documents including but not limited to study protocols and reports, validation documents, SOPs, and test methods
• Build and maintain your team, and train 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 (research, quality, regulatory, project management)
• Lead CMC sub-teams or represent process development in for assigned projects and support project activities including authoring of relevant CMC sections in regulatory documents

You Bring…

Qualifications

• PhD and >12 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) with solid foundation in vectorology, and scale-up
• Hands-on experience with product characterization methods relevant to viral vectors and cell therapy products (release and characterization assays, titration methods, infectivity assays, transduction assays) and other cell lines (release and characterization assays)
• Expertise in technology transfer to CDMOs and external manufacturing
• Experience with process development supporting early and/or late-stage development of biologics (cell therapies, gene therapies, vaccines, antibodies…)
• Expert knowledge of cGMP and quality systems requirements
• Deep familiarity with FDA and EMA guidance documents relevant to viral vectors and cell lines
• Authorship of CMC sections of regulatory documents (IND/BLA), and experience in engaging 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 influences 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 in order to fulfill our mission
• Successful experience leading and managing high performing matrixed teams
• Prior experience with TILs, T-cells, NK cells, induced pluripotent stem cells (iPSC), or other primary cells is a plus.
• Excellent oral and written communication skills.

Apply for this Job