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Manufacturing Science

2 months ago

California, United States Turnstone Biologics Full time

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

The ideal candidate should possess a keen attention to detail 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, including MSAT, Process Development, Quality Assurance, Quality Control, and Supply Chain.

Key Responsibilities:

  • Engage with manufacturing leadership to provide strategic and technical insights on 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 related to process deviations and impact assessments, identifying suitable 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 relation to deviations and change controls.
  • Provide technical support for process-related deviations to manufacturing.
  • Facilitate process improvement initiatives involving cross-functional teams, including Manufacturing, Quality, and Process Development.
  • Perform risk assessments and investigations, including root cause analysis, utilizing systematic approaches and industry best practices.
  • Determine corrective and preventive actions for process-related deviations.
  • Assist in technology transfers and the execution of verification runs.
  • Support process Failure Mode and Effects Analysis (FMEA).
  • Participate in and report to a cross-functional development team to enhance production activities.
  • Ensure successful manufacturing production runs by assessing risks, implementing preventative measures, and troubleshooting equipment and process issues.
  • Additional responsibilities as assigned.

Professional Experience/Qualifications:

  • Bachelor's degree in life sciences, engineering, or a related field with 4+ years of industry experience; a Master's degree with 3+ years of experience; or a PhD with 1+ year of experience.
  • A minimum of 3 years of experience with the complexities of manufacturing cell therapy-based therapeutics, such as TIL, CAR-T, TCR, or stem cell products.
  • Adept at managing competing priorities effectively in a fast-paced environment.
  • Prior experience with GMP manufacturing to support person-in-plant and manufacturing workflows.
  • Experience in managing external relationships with CMO partners or clients, employing a mature and thoughtful communication approach.
  • 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.
  • Strong written and verbal communication skills.
  • Excellent interpersonal skills with a communication style that aligns with the values of Turnstone.
  • This role may be based remotely within North America.

Compensation/Benefits:

At Turnstone, we prioritize the well-being and success of our team members. We offer a competitive compensation package that 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 inclusivity 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.