Associate Scientist, Cell Therapy

We are a clinical stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. iNKT cells are a distinct T cell population that combine durable memory responses with the rapid cytolytic features of natural killer (NK) cells. iNKT cells offer distinct therapeutic advantages as a platform for allogeneic therapy in that the cells naturally home to tissues, aid clearance of tumors and infected cells and suppress Graft versus Host Disease (GvHD). Our proprietary platform is designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. As such, we believe that our approach represents a highly versatile application for therapeutic development in cancer and immune diseases. We have leveraged our platform and manufacturing capabilities to develop a wholly owned pipeline for both native and engineered iNKT cells.

Role Description

If you are result-driven, passionate in cell therapy assay developments to characterize and release allogenic cell therapy products suitable for clinical and commercial use and a critical thinker, this will be your opportunity to join our journey. Our Lexington, MA CMC development team is seeking an associate scientist to develop and qualify various analytical assays to build our internal analytical capacity and platform to move our multiple proprietary projects into clinical stages as well as validating the assays to support our most advanced iNKT project commercialization. This is an exciting opportunity for a motivated associate scientist to grow into analytical subject matter expert to contribute and grow in a fast-paced and team-oriented environment.

Key responsibilities

• An innovative and enthusiastic associate scientist to contribute to analytical assay design and optimization to characterize end to end iNKT manufacturing process and release the clinical materials
• A dynamic and experienced assay development and execution junior scientist who can leverage available new technologies and experience to work with discovery, process development and manufacturing team to build internal analytical development capacity and platform to advance multiple projects into clinical manufacturing.
• A results-oriented scientist who enjoys coordination and collaboration with cross functional team in a fast-paced environment with a global cross-functional team.
• Collaborate with internal/external key stakeholders including CROs, CMOs and consultants to advance MiNK pipeline programs to market
• Able to contribute to identify and/or develop cutting edge analytical assays for implementation and optimization
• Act as a key analytical assay development contributor and/or owner to lead method transfer from discovery to analytical and then transfer the qualified assays to QC. Provide appropriate mentoring and training to QC members for execution and serve as a subject matter expert or contributor to resolve any technical issues
• Provide technical support for all Module 3 submission to regulatory agencies and serve as a key contributor and/or subject matter expert to provide technical support

Qualifications and Skills

• BS in cell biology, engineering, molecular biology, pharmaceutical chemistry or a related discipline with at least 5-8 industry experience or master’s degree with minimal 4 yrs of industry experience
• Industry experience and strong hands-on skills in assay execution, development and qualification including qPCR, cytotoxicity, flow cytometry, ELISA and cell-based potency etc.
• Demonstrated experience in leading transfer tech transfer and training QC analysts]
• Experience in characterizing and release testing methods for lentivirus vector is a plus
• Knowledge in allogenic cell product process development is a plus
• Strong organizational, multi-tasking and communication skills
• Good understanding and knowledge of regulatory requirements for cell therapy product analytical assay development and stability is desired
• Able to work in a fast and dynamic environment

Job Type: Full-time

Pay: From $94,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off

Schedule:

• Monday to Friday

Supplemental Pay:

• Bonus pay

Ability to commute/relocate:

• Lexington, MA 02421: Reliably commute or planning to relocate before starting work (Required)

Experience:

• industry: 3 years (Required)
• analytical assay: 3 years (Required)
• cell therapy: 2 years (Required)

Work Location: One location