Position Description

Tr1X is seeking a highly motivated and talented individual who has the desire to excel in a fast-paced biotech environment. As Senior Process Engineer, MSAT, you will report directly into Director of Process Development and Manufacturing in the Technical Operations department and function as the manufacturing process SME to support allogeneic Treg-based cell manufacturing processes. The incumbent will be responsible for all technical/manufacturing data functions to facilitate robust GMP manufacturing, while also contributing to the continuous improvement of manufacturing systems and processes. This individual will be responsible for early-stage product candidates transfer from PD (Process Development) team to the Manufacturing group at the external CDMO and ensure readiness for clinical stage production. This individual will also spearhead tech transfers to new manufacturing sites, both in the US and abroad. This role will collaborate closely with multiple cross-functional teams including Analytical Development, Process Development, Quality, Supply Chain and External Manufacturing to coordinate critical deliverables. The individual will also maintain a focus on innovation and manufacturing process improvements to develop next-generation allogeneic T cell manufacturing processes. The ideal candidate will possess a proven track record overseeing GMP operations and a strong understanding of GMP environment and requirements in the context of cell therapy/ biologics.

Key Duties and Responsibilities

May include but are not limited to:

• Provide strategic and technical manufacturing support, guidance, and direction aligned with CMC and Technical Operations' vision, mission, and goals.
• Coordinate tech transfer activities to external manufacturing sites at different stages of development, including establishment of business processes for technology/knowledge transfer (e.g., Technology Transfer Package, Process Description) from PD to external clinical facilities for early phase GMP clinical manufacturing and site-to-site transfers.
• Collaborate closely with the internal/external Process Development and External Manufacturing teams on transition activities after IND stage for the transfer of critical process knowledge, life cycle management of the programs, new technology evaluation, and process modifications required per CMO.
• Contribute to continuous process improvement pre and post IND (e.g., closed systems, automation, raw material qualification, biological understanding) through a cross-functional working group sponsored by PD.
• Facilitate cross-functional interaction with major stakeholders (Regulatory, Quality, Research, Clinical) to support manufacturing troubleshooting and process optimization, including leading risk management activities for identifying gaps and process risk assessments.
• Provide technical support for external cGMP manufacturing operations, including implementing process changes/improvements, training for tech transfers, troubleshooting, deviations, root cause investigations, CAPAs, and change controls.
• Implement new technologies and process improvements into the quality management system, author comparability assessment studies, and support Process Characterization (PC) activities to develop an understanding of Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs).
• Support regulatory filings from a technical perspective, health authority questions, agency interactions, and product-related inspections by authoring and reviewing regulatory sections and dossiers.
• Promote a positive culture among internal team members, stakeholders, and external CMO; present manufacturing performance summaries and run data to internal and external partners.
• Lead and participate in high-impact cross-functional initiatives as required.
• Other duties as assigned

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:

• PhD in a scientific discipline (e.g., Biochemical Engineering, Chemical Engineering, Biotechnology or Biological Sciences or other relevant degree with at least 4 years relevant industry experience (equivalent combination of education and/or experience will be considered)
• A minimum of 2+ years in T cell GMP manufacturing
• Highly desired is experience with (i) lentiviral vectors, (ii) range of cell-expansion devices (e.g. G-rex, Prodigy, single use bioreactors) and (iii) cell purification/isolation devices
• Demonstrable experience with methodologies related to cell therapy process design, scale-up and scale-out cell production processes
• Excellent knowledge of CMC requirements pre-and post-IND, technical writing skills and working knowledge of FDA and ICH regulatory guidance and regulations
• Demonstrated ability to work effectively in a dynamic, complex and fast-paced team environment

 Skills and Ability:

• Authentic, ability to actively serve, collaborate, and develop relationships in, and outside the organization.
• Results-oriented, resourceful individual with a highly entrepreneurial style and ability to achieve results in a fast-paced rapidly changing environment without the infrastructure found in large companies
• Outstanding written and oral communication skills are essential and critical for this role. For example, the leader should be proficient in order to present thoughts clearly and concisely to a wide variety of stakeholders including senior management and partners
• Strong core values such as teamwork, integrity, accountability is required
• Experience in statistical analysis and DOE using JMP is desired
• Experience using Tableau or an analogous dashboarding software is preferred
• Travel may be required.

Optimally you have

• Prior experience in allogeneic cell therapy process development and/or manufacturing
• Late stage and/or commercial T cell experience

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