Principal Engineer II (Tech Transfer Lead), MSAT

We are looking for a hands-on leader to own the transfer of our cell therapy processes and analytical methods to a CDMO partner. This role is about learning the science in our process development lab, translating it into phase-appropriate, scalable operations, and ensuring the CDMO can run successfully. You’ll be the point person for tech transfer, driving alignment across process and analytical development, MSAT, Quality, and CDMO teams to move our programs into clinic. This role will transition into a clinical facing technical support role along with clinical start up after the transfer is complete.

Responsibilities

• Hands-on learning: Build practical knowledge of our platform by working directly in the development lab with development counterparts. Develop expertise in processing equipment, workflows, and assays in order to deliver successful technology transfer.
• Tech Transfer Documentation Ownership: Prepare and review tech transfer documents including process descriptions, sampling plans, stability protocols, operator training materials, risk assessments, study protocols, and data packages.
• Cross-functional leadership: Work closely with project management support to lead the tech transfer team with clear timelines, deliverables, risk registers, and escalation pathways; coordinate inputs across Development, MSAT, and Quality.
• Analytical Method Transfer: Own process and analytical method transfer from internal PD lab to CDMO, ensuring readiness for engineering and GMP runs.
• End-to-end Transfer Ownership: Ownership of tech transfer project from initial project kick-off through clinical start-up at the CDMO.
• On-the-floor oversight: Provide technical coverage during CDMO engineering and GMP runs; act as Person in Plant (PiP) to troubleshoot, align stakeholders, and drive on-time execution.
• Issue resolution: Lead transfer related investigations using root cause analysis tools and draft CAPAs to correct.
• CDMO partnership: Develop strong working relationships with CDMO technical leads; create joint ownership of deliverables and ensure transparent, timely communication.
• Be Awesome: Exhibit a positive attitude and a proactive approach to problem-solving, embracing challenges with enthusiasm and a solutions-oriented mindset.

Minimum Experience, Education, and Specialized Knowledge and Skills:

Must thrive in a fast-paced, growing, and innovative environment where flexibility, resourcefulness, resiliency, and communication skills are key. Excellent interpersonal and communication skills, ability to develop important relationships with colleagues, and being an all around good company citizen are essential.

• Bachelor’s, Master’s, or Ph D degree in Engineering, Life Sciences, or a related field.
• 8+ Experience or equivalent in a cGMP manufacturing environment, with a focus on technology transfer and process support.
• Strong knowledge of manufacturing processes, root cause analysis, and corrective action planning.
• Proficiency in project management tools and techniques.
• Excellent communication and leadership skills, with the ability to coordinate cross-functional teams and manage relationships with CDMO partners.
• Experience with statistical analysis and process trending programs.
• Ability to work independently and collaboratively in a dynamic environment.
• Demonstrated positive attitude and enthusiasm for problem-solving and overcoming challenges.
• This position will require up to 50% domestic travel during tech transfer activities to ensure proper oversight at the CDMO. After tech transfer is complete, travel requirements will reduce to < 20%.

Preferred Skills

• Preferred experience in the development and transfer of early phase cell therapy processes.
• Familiarity with regulatory expectations for early-phase submissions and inspections.
• Ability to analyze process and QC data using statistical tools to inform decisions.
• Track record of successfully enabling IND or first-in-human manufacturing campaigns.