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Principal Scientist, Viral Vector Process Development

Bedford, MA

Our Opportunity… 

We’re looking for a highly motivated, collaborative, and experienced scientist with a strong background in viral vector process development and a flexible and creative mindset to help drive the development of our cell therapy products targeting cancer. The successful candidate will lead efforts in late-stage process development including process characterization. As part of our Technical Operations team, you will be a vital part of a highly collaborative team working to achieve Obsidian’s vision by translating innovative science into medical breakthroughs for patients, starting with our lead program OBX-115.

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 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… 

• Drive the design and execution of experiments for the late-stage development of the cGMP manufacturing process and associated process controls for clinical/commercial supply of viral vectors and associated cell lines/banks.
• Plan, design, execute, and analyze process characterization studies to define critical process parameters and critical quality attributes utilizing statistical design of experiments (DOE) to evaluate process robustness and establish control strategies.
• Compile, organize, and analyze data across multiple experiments to enable process understanding and logical, data-driven decisions.
• Manage and mentor a team of scientists and engineers fostering professional development and technical growth.
• Innovate solutions to address current technical challenges and evaluate/ incorporate next-generation process technologies.
• Lead and support 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. Occasional travel will be required.
• Supply development viral vector materials to support research/non-clinical studies, analytical development, and CDMO technology transfer activities.
• Represent process development in CMC sub-teams for assigned projects.
• Author relevant CMC sections in regulatory documents and support responses for regulatory agencies.
• Collaborate closely with internal stakeholders (Analytical Development, Quality Control, Research, Quality Assurance, Regulatory, Project Management) in a fast-paced, rapidly developing environment.

You Bring… 

Core Qualifications 

• PhD. in a relevant discipline (chemical or biochemical engineering or related field) and 7+ years relevant industry experience, or MS and 12+ years of relevant industry experience (including at least 2 year in cell or gene therapy) with a progressive track record of leadership and impact.
• Subject matter expertise in mammalian cell culture, particularly adherent cell culture and related aspects such as cell metabolism/media optimization, engineering fundamentals on cell culture scale-up/down, and cell biology/physiology.
• Subject matter expertise in downstream lentiviral and/or retroviral vector processing (e.g. TFF, UF/DF, filtration).
• Process Development experience supporting late-stage development of viral vectors inclusive of process characterization.
• Familiarity with QbD Design, design of experiment (DOE), FMEA, process justification, residual testing studies and justification.
• Strong skills in statistical data analysis, including data graphing and trending, correlation search, comparability analyses, statistical design of experiments, and familiarity with software such as JMP and Prism.
• Demonstrated success in technology transfer to CDMOs and technical oversight of external manufacturing during tech transfer.
• Strong organization and record-keeping skills, including an ability to manage multiple responsibilities in parallel.
• A highly collaborative working style – you build trusting relationships, invite and share ideas and feedback, productively challenge your own and others’ assumptions to generate new ideas and facilitate better outcomes.
• Willingness and ability to adapt to changes in priorities in a fast-paced, rapidly developing environment to advance our mission.
• Scientific curiosity, and a track record of self-directed learning.
• Self-motivation and a proven ability to work with general direction, exercise good judgement, and seek the information and support you need to meet objectives and timelines.
• Proven ability to manage matrixed projects and tasks to completion, anticipating and elevating risks and obstacles, and adjusting to effective contingency plans.
• A track record of successful performance in a matrixed team environment.

Bonus Qualifications 

• Hands-on experience with product characterization methods relevant to viral vector and ancillary materials (e.g. HPLC, SEC, ELISA, Flow cytometry, etc.).
• Knowledge of FDA and EMA guidance relevant to gene and cell therapy.
• Experience authoring CMC sections of regulatory documents (IND/BLA) and engaging regulatory authorities.
• Strong working knowledge of cGMP and Quality systems requirements.

Please no agency solicitation.

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