Senior Scientist, Cell Therapy Process Development

Obsidian Therapeutics

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Post Date: 04/01/2021
  • Website: obsidiantx.com
  • Company Address: Obsidian Therapeutics, Inc. 1030 Massachusetts Avenue Suite 400, Cambridge, MA, 02138

About Obsidian Therapeutics

Obsidian Therapeutics is a biotechnology company using its proprietary cytoDRiVEâ„¢ technology to pioneer a new generation of controllable cell and gene therapies to treat diseases like cancer.

Job Description

About Us…

Obsidian Therapeutics is pioneering the development of controllable cell and gene therapies to deliver transformative outcomes for patients with intractable diseases. Obsidian’s programs apply our CytoDriveTM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety.

Our Opportunity…

We’re looking for a highly motivated scientist with a strong background in cell therapy and/or 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.

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.

Located in the heart of Cambridge, 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. We offer competitive salary and benefits, and potential for employee ownership through stock options. Apply to [email protected].

You Will…

  • Contribute your expertise to develop clinical/commercial manufacturing processes, 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 associate process controls for clinical supply of cell therapy product (and related materials) meeting yield and quality targets
  • Author and review technical and scientific documents including but not limited to study protocols and reports, validation documents, SOPs, and test methods
  • Help build the team, and train and mentor team members on experiment design, data analysis with appropriate scientific rigor and proper documentation in lab notebooks
  • Innovate solutions to address current technical challenges and evaluate/ incorporate next-generation process technologies
  • Supply development materials (viral vector, cell product) to support research/nonclinical studies, analytical development, and CDMO tech transfer activities
  • 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
  • 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

You Bring…

Core Qualifications

  • Ph.D. and 3+ years of industry experience in a relevant discipline (chemical engineering, biomolecular engineering, biotechnology or relevant field), or MS plus 10 years relevant experience.
  • Subject matter expertise in mammalian cell culture and related aspects such as cell metabolism/media optimization, engineering fundamentals on cell culture scaleup/down, cell biology/physiology
  • Hands-on experience with product characterization methods relevant to cell therapy (e.g. flow cytometry)
  • Highly collaborative working style, and ability to adapt in a fast-paced, rapidly developing environment
  • Ability to work with minimal direction to meet objectives and timelines, adapting to changes and priorities in order to fulfill our mission

Bonus Qualifications

  • Prior experience with T-cells, NK cells, induced pluripotent stem cells (iPSC), or other primary cells is a plus.
  • Demonstrated track record with process development supporting early and/or late-stage development of biologics (cell therapy, gene therapy, vaccines, antibodies…)
  • Experience with and technology transfer to CDMOs and external manufacturing oversight
  • Familiar with FDA and EMA guidance documents relevant to gene and cell therapy
  • Experience authoring CMC sections of regulatory documents (IND/BLA) and engaging regulatory authorities
  • Experience with Design of Experiment (DOE) approaches and application to process development
  • Strong working knowledge of cGMP and quality systems requirements
  • Prior experience in managing people and matrixed teams

Related Jobs

Senior Associate Scientist, Vector Process Development

Obsidian Therapeutics - Cambridge, MA, US

Senior Scientist, Cell Therapy Process Development

Obsidian Therapeutics - Cambridge, MA, US

Senior Associate Scientist, Analytical Development

Obsidian Therapeutics - Cambridge, MA, US

Senior Research Associate, In Vivo Pharmacology

Obsidian Therapeutics - Cambridge, MA, US

Scientist, Cell Engineering, Discovery

Obsidian Therapeutics - Cambridge, MA, US
Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.