Senior/Principal Scientist, Cell Therapy Process Development

Location
Bedford, MA
Posted
May 09, 2022
Ref
4291057004
Hotbed
Genetown
Required Education
Masters Degree/MBA
Position Type
Full time

Senior/Principal Scientist, Cell Therapy Process Development

Bedford, MA

About Us…

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our CytoDriveTM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in preclinical development for the treatment of patients with metastatic melanoma and other solid tumors.

We’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our research team is based in the heart of Cambridge, MA, and our Technical Development, Manufacturing & Quality team is based in our brand new facility in Bedford, MA to support our growth.  Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.

Our Opportunity…

We’re looking for a highly motivated scientist with a strong background in cell therapy process development to help drive the development of multiple cell therapy products in our pipeline targeting cancer. As part of our Technical Development and Manufacturing department 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 cytoTIL15, engineered to make TIL (tumor infiltrating lymphocyte) treatment more effective for more patients.

This is a unique opportunity to be a contributor in a well-funded pre-clinical company with blue chip investors, field-leading advisors, best-in-class partners (BMS and Vertex), 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…

  • Contribute your expertise to the development of clinical/commercial manufacturing processes, tech transfer to CDMOs, oversight of external manufacturing, and regulatory filings.
  • Drive the design, execution, and interpretation of experiments for development of the cGMP manufacturing process and associated process controls for clinical supply of cell therapy product (and related materials) meeting yield and quality targets.
  • Compile, organize, and analyze data across multiple experiments to enable process understanding and logical, data-driven decisions.
  • Work closely with junior scientists to support their career growth and success in the lab, including mentoring on experiment design, data analysis with appropriate scientific rigor, and proper documentation in lab notebooks.
  • Author and review technical and scientific documents including but not limited to study protocols and reports, validation documents, SOPs, and test methods.
  • Lead and support key technology transfer document preparation, technology transfer and implementation of the process, and serve as the technical point of contact for the process development function for assigned projects.
  • Innovate solutions to address current technical challenges and evaluate/incorporate next generation process technologies.
  • Establish strong relationships and collaborate closely with internal stakeholders (research, quality, regulatory, project management).
  • Represent process development in CMC sub-teams for assigned projects and support project activities including authoring of relevant CMC sections in regulatory documents.
  • Supply development materials (viral vector, cell product) to support research/non-clinical studies, analytical development, and CDMO tech transfer activities.

You Bring…

Core Qualifications

  • PhD in a relevant discipline (chemical or biochemical engineering or related field) and 3+ years relevant industry experience, or MS and 10+ years of relevant industry experience (including at least 2 years in cell therapy, preferably with T-cells) with a progressive track record of leadership and impact.
  • 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.
  • Deep subject matter expertise in development of clinical and/or commercial cell therapy processes.
  • Hands-on experience with standard cell processing and analytical equipment for cell therapies, such as cell separators, cell wash/harvest (i.e. Lovo), cell counters (i.e. NC200), flow cytometers.
  • Expertise in mammalian cell culture and related aspects such as cell metabolism/media optimization, engineering fundamentals on cell culture scale-up/down, cell biology/physiology.
  • A highly collaborative working style – you build trusting relationships, invite and share ideas and feedback, productively challenge own and others’ assumptions to generate new ideas and facilitate the better outcomes.
  • Self-motivation and a proven ability to work autonomously with general direction to meet objectives and timelines.
  • Flexibility, a willingness to adapt to changes in priorities in order to fulfill our mission.
  • Excellent communication skills.
  • Scientific curiosity, and a track record of self-directed learning.

Bonus Qualifications

  • Experience with technology transfer and PiP, particularly to an external manufacturing partner.
  • Experience with or expertise in formulation and cryopreservation of cell therapy products.
  • Direct experience with TIL.
  • Understanding of regulatory guidance and requirements for cell therapy products.
  • Experience with viral vector or viral transduction is a plus.

Job level will be based on overall experience and capabilities.

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Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.