Process Engineer / Senior Process Engineer, Cell and Gene Therapy

We are a new company, currently in stealth mode, founded around a proprietary technology to develop patient specific immunotherapy focused on solid tumors. The company will grow rapidly over the next year with the goal of being in the clinic within 2 years, backed by a strong foundation of VC team Our approach deploys key de-risked licensed technology to address and solve existing issues of cell therapy for solid tumor patients. We are building a manufacturing first culture; the process is truly the product for cell-based therapies, and thoughtful CMC development and a fit for purpose GMP network and supply chain will be a major focus as we launch and advance the company.

There are over 1 million patients with cancer types where cell therapies have been shown to be ineffective. With our process and product, we will be able to treat a much larger proportion of these patients, addressing a major unmet clinical need.

Process Engineer / Senior Process Engineer, Cell and Gene Therapy

We are actively seeking a motivated Process Engineer with a specialization in cell therapy to join our Process Development team. This hands-on laboratory position will be instrumental in advancing the clinical manufacturing process of engineered T cells, spanning from early-phase development to commercialization. Your duties will include evaluating technology and process improvements, executing comprehensive process scale-up, and playing a pivotal role in establishing a commercially viable process. Additionally, you will be essential in conducting process characterization and collaborating with MSAT for seamless technology transfer in a cGMP-compliant environment. The ideal candidate will have a strong foundation in cell expansion, isolation, cryopreservation and final formulation for clinical manufacturing for cell therapies, bioprocess development, and cGMP manufacturing. This role is based in Camarillo, CA, and reports to the Senior Director, Process Development.

Job Description and Specific Responsibilities

Design and develop GMP manufacturing processes for T cell immunotherapies using novel cell culture manufacturing technologies

Perform scale-up/scale-out of processes developed in R&D for progress into early and late phase clinical manufacturing

Develop and optimize unit operations for automated cell isolation, washing, cryopreservation

Perform product characterization to establish critical process parameters and monitor critical quality attributes

Support in-process and final product analytical testing using cell-based assays

Works cross-functionally to drive innovation for T-cell production in a GMP setting.

Process SME for tech transfers to external manufacturing sites

Works cross functionally and in close collaboration with R&D and MSAT teams for refining product characteristics and process operations in GMP and non-GMP settings

Supports the CMC sections of regulatory filings for the company’s filings.

Partners with analytical team to evaluate in process stability, drug product stability, and in-use product stability

Writes technical and product development reports to support process development and regulatory filings

Leads process monitoring during process development and continues to support MSAT during manufacturing

Assist with PD lab buildout including equipment evaluation, program optimization and purchase

Qualifications/Experience

BS/MS in a biological science, chemical engineering, or other relevant discipline with 3+ years of relevant experience in cell therapy development, preferably in engineered primary cells

A deep understanding of closed process technologies like G-Rex, and automated cell washers and concentrators like the Rotea, Sefia, Cue or equivalent

Experience or familiarity with working in a manufacturing environment under cGMP

Excellent interpersonal, verbal and written communication skills

Strong organizational and record keeping skills.

Experience with flow cytometry and cell counting strongly preferred

Proficiency in Excel, JMP and/or Prism preferred

The salary range for this position is 90,000 to $145,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

This is an on-site role based in Camarillo, CA (greater Los Angeles Area).

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.