Senior Process Engineer, MSAT

Turnstone Biologics is seeking a driven and experienced Senior Process Engineer to support the Manufacturing Science & Technology Team (MSAT). This successful candidate will support the Turnstone manufacturing network by providing technical and scientific support of the TIDAL-01 operations process, such as: leading or supporting technology transfers, Person-In-Plant (PIP) support, root cause investigations, impact assessments, process improvements, and process monitoring. The successful candidate should be detail-oriented and enjoy working in a dynamic, high-paced environment to deliver innovative therapies to patients in need.

This is a key position requiring routine interactions, Internal and External Manufacturing Operations, MSAT, Process Development, Quality Assurance, Quality Control, and Supply Chain. The role will support the Turnstone Manufacturing team, based in both Ottawa, CAN and San Diego, California, and external manufacturing partners. As such, flexibility to provide remote support for manufacturing operations is required. In addition, this candidate will support the evaluation of new or future external and internal manufacturing capabilities.

KEY RESPONSIBILITIES

• Interact with Manufacturing leadership to influence strategic and technical guidance on ongoing clinical production
• Provide on-site/remote Subject Matter Expert (SME) support for GMP operations at CMOs as Person-In-Plant (PIP)
• Provide technical process and operational trainings to support clinical manufacturing execution, process changes, and process knowledge
• Lead technology transfers and support execution of verification runs
• Lead investigations from process deviations and impact assessments, identifying appropriate subsequent CAPAs for clinical MFG productions
• Collaborate with Process Development teams on implementation of process optimizations, and new technology, critical reagents, and materials
• Write and review technical documentation (batch records, SOPs, protocols & reports)
• Author impact assessments in support of deviations and change controls
• Lead/Support process improvement activities involving cross-functional teams including Manufacturing, Quality, and Process Development
• Perform risk assessments and investigations including root cause analysis utilizing a systematic approach and industry best practices
• Lead/Support process FMEA
• Participate and report to a cross-functional development team to advance production activities
• Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues
• Additional duties as assigned.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

• Bachelor’s degree, in life sciences, engineering or related field and 6+ years of industry experience; Masters degree with 5+ years of experience; PhD and 3+ years of experience
• 3+ years experience with the manufacturing and operational complexity of cell therapy-based therapeutics such as TIL, CAR-T, TCR, or stem cell products is required.
• Enjoy working in a fast-paced environment, able to manage competing priorities effectively and adapt to changing priorities
• Prior experience with GMP manufacturing to enable support of person-in-plant and manufacturing workflows
• Experience managing external relationships such as CMO partners or clients as a CMO provider, with a mature and thoughtful communication approach to support strong partnerships
• Be able to travel to perform and complete listed responsibilities.
• Experience in Process Development, Manufacturing, and/or Manufacturing Science and Technology (MSAT) for cell or gene therapies preferred
• Strong communication skills, both written and oral
• Strong interpersonal skills and a communication style that matches the Turnstone style: respectful, transparent, and constant
• This role will be formally positioned out of Memphis, TN or San Diego, CA although consideration will be made for remote candidates in the US.

COMPENSATION/BENEFITS

At Turnstone, we prioritize the well-being and success of our team. Join us and enjoy a competitive compensation package, including a base salary and performance-based bonuses. Our comprehensive benefits include:

• Healthcare Coverage: Medical, dental, and vision insurance for you and your dependents.
• Retirement Planning: 401(k) plan with employer contributions.
• Time Off: Generous paid time off, including vacation, sick leave, and holidays.
• Workplace Flexibility: Flexible schedules and remote work options.

Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.