Position Description

Tr1x, Inc. is seeking a Sr. Scientist of Bioanalytical Sciences to help build the analytical development activities in support of Tr1x's cell therapy portfolio. The successful candidate will develop and optimize the key analytical methods, including analytical assays, characterization assays, etc., that meet regulatory requirements for cell therapy applications. This position will focus on in-process and final release testing of regulatory T cells and will be responsible for assisting with the authorship of regulatory documents modules.

Please note that this position will be based in San Diego, CA and will require that the successful candidate is on-site to support key activities.

Key Duties and Responsibilities

• Oversee - design, develop, optimize and execute bioanalytical and/or molecular assays, as well as analyze and interpret results to support the process development and drug product characterization.

• Lead - tech transfer of analytical methods from/to internal and external stakeholders and provide trainings.

• Review - author and review key documentation (Standard Operating Procedures, Process Flow Diagrams, Sample Maps, Test Methods, etc.) in support of internal and external projects.

• Document - laboratory procedures and experiments with great attention to details, including to maintain meticulous up-to-date laboratory notebooks (ELN).

• Support - provide assistance and mentorship to junior team members and may provide guidance and supervision to other junior team members as needed.

• Keep - abreast of new technologies to optimize or improve current testing methods and expand the product and process understanding and serve as a subject matter expert in regulatory interactions

The Team - Yes You Belong!
We are building a diverse, bold, agile, and collaborative organization where each team member works closely and communicates respectfully with each other. Tr1X leadership has high expectations for themselves and for you (and so should you!): we expect the company and all its employees to be deeply focused on bringing Tr1X's therapies to patients at an accelerated pace.

Key attributes to this role include a "can do" attitude, enthusiasm for science, integrity, attention to details, problem solving, collaborative spirit.

You have:

• Ph. D. in life sciences with at least 6+ years of relevant industry experience.
• Strong preference for candidates with experience in immunology and/or autoimmune disease with a focus on engineered T cells and/or other immune cell types
• Must have in-depth knowledge and hands-on experience in analytical method development and good understanding of method lifecycle management from development to qualification and validation and beyond.
• Knowledge and experience developing multi-parametric flow cytometry, ELISA, qPCR, ddPCR or dPCR, cell count, and cellular bioassays are required.
• Demonstrated knowledge and experience developing and troubleshooting analytical methods and interpreting data are required.
• Knowledge and working experience in global regulatory CMC documents and familiarity with GMPs and qualification/ validation practices.
• Excellent communication (both written and verbal), project management, and organizational skills are required.
• Self-starter with demonstrated ability to deliver high-quality results in a fast-paced development environment.
• Strong computer skills and working experience with Microsoft Office Software (Word, Excel, Visio, etc.), Flowjo, Prism and JMP are required.
• Ability to build and maintain positive and collaborative relationships with management and peers and must be willing to work as part of a team.
• Must be able to don and wear appropriate clean room attire and have the ability to wear all required Personal Protective Equipment (PPE).

Optimally you also have

• Knowledge and working experience of current Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents (US and EU) as they relate to quality release and stability testing of cell therapy products Experience in cell therapy applications with regulatory T cells and lentiviral vectors (LVV) is a plus.
• Experience in authoring relevant CMC sections of regulatory submissions.
• Experience working with external CDMO and analytical sites.

You are

• Legally entitled to work for any employer in the US.

We offer

In addition to a competitive compensation package with stock options, Tr1X offers comprehensive benefits for our employees and their families. This includes:

• Medical, dental and vision insurance
• 401k with employer match
• PTO
• Long Term Disability (LTD)
• Company paid holidays