Manufacturing Science Process Engineer

1 week ago

California, United States Turnstone Biologics Full time

Turnstone Biologics is in search of a motivated and skilled Process Engineer to enhance the Manufacturing Science & Technology Team (MSAT). This role is crucial for providing technical and scientific assistance to the Turnstone manufacturing network, specifically in relation to the TIDAL-01 operations process. Responsibilities include leading or aiding technology transfers, offering Person-In-Plant (PIP) support, conducting root cause analyses, performing impact assessments, and implementing process enhancements.

The ideal candidate will be detail-oriented and thrive in a dynamic, fast-paced environment, dedicated to delivering innovative therapies to patients. This position necessitates regular collaboration with both Internal and External Manufacturing Operations, MSAT, Process Development, Quality Assurance, Quality Control, and Supply Chain teams.

Key Responsibilities:

  • Engage with Manufacturing leadership to provide strategic and technical direction for ongoing clinical production.
  • Deliver on-site or remote Subject Matter Expert (SME) support for GMP operations at Contract Manufacturing Organizations (CMOs) as Person-In-Plant (PIP).
  • Assist in investigations of process deviations and conduct impact assessments, determining appropriate corrective and preventive actions for clinical manufacturing productions.
  • Collaborate with Process Development teams to implement process optimizations and integrate new technologies, critical reagents, and materials.
  • Manage change controls associated with processes and process materials.
  • Draft and review technical documentation, including batch records, Standard Operating Procedures (SOPs), protocols, and reports.
  • Conduct data analysis based on clinical manufacturing process and product data.
  • Support the collection and management of manufacturing process data.
  • Prepare impact assessments in response to deviations and change controls.
  • Provide technical support for process-related deviations and assist manufacturing teams.
  • Engage in process improvement initiatives involving cross-functional teams, including Manufacturing, Quality, and Process Development.
  • Conduct risk assessments and investigations, employing systematic approaches and industry best practices for root cause analysis.
  • Identify corrective and preventive actions for process-related deviations.
  • Facilitate technology transfers and oversee verification runs.
  • Contribute to process Failure Mode and Effects Analysis (FMEA).
  • Participate in cross-functional development teams to advance production activities.
  • Ensure successful manufacturing production runs by assessing risks, implementing preventative measures, and troubleshooting equipment and process issues.
  • Perform additional duties as assigned.

Professional Experience/Qualifications:

  • Bachelor's degree in life sciences, engineering, or a related field with a minimum of 4 years of industry experience; a Master's degree with 3+ years of experience; or a PhD with at least 1 year of experience.
  • A minimum of 3 years of experience in the manufacturing and operational complexities of cell therapy-based therapeutics, such as TIL, CAR-T, TCR, or stem cell products.
  • Able to thrive in a fast-paced environment, effectively managing competing priorities and adapting to changes.
  • Prior experience with GMP manufacturing to support person-in-plant and manufacturing workflows.
  • Experience managing relationships with external partners, such as CMO clients, demonstrating effective communication to foster strong partnerships.
  • Willingness to travel to fulfill responsibilities.
  • Experience in Process Development, Manufacturing, and/or Manufacturing Science and Technology (MSAT) for cell or gene therapies is preferred.
  • Excellent communication skills, both written and verbal.
  • Strong interpersonal skills with a communication style that aligns with the values of Turnstone: respectful, transparent, and consistent.
  • This role is based in Memphis, TN or San Diego, CA, with consideration for remote candidates in North America.

Compensation/Benefits:

At Turnstone, we prioritize the well-being and success of our team members. We offer a competitive compensation package, which includes a base salary and performance-based bonuses. Our comprehensive benefits package includes:

  • Healthcare Coverage: Medical, dental, and vision insurance for employees and their 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 is committed to fostering an inclusive environment and encourages applications from individuals with disabilities. Accommodations are available upon request for candidates participating in all aspects of the selection process. We appreciate all applicants for their interest; however, only those selected for an interview will be contacted.

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