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Manufacturing Science Process Engineer

2 months ago

California, United States Turnstone Biologics Full time

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

The ideal candidate will thrive in a fast-paced environment, demonstrating attention to detail while working collaboratively with various teams. This position requires regular interaction with both internal and external manufacturing operations, including Process Development, Quality Assurance, Quality Control, and Supply Chain.

Key Responsibilities:

  • Engage with manufacturing leadership to provide strategic and technical guidance for ongoing clinical production.
  • Deliver on-site and remote Subject Matter Expert (SME) support for GMP operations at Contract Manufacturing Organizations (CMOs).
  • Assist in investigations related to process deviations and conduct impact assessments, determining appropriate corrective actions.
  • Collaborate with Process Development teams to implement process optimizations and integrate new technologies and materials.
  • Manage change controls associated with processes and materials.
  • Draft and review essential technical documentation, including batch records, SOPs, protocols, and reports.
  • Analyze data derived from clinical manufacturing processes and products.
  • Support the collection and management of manufacturing process data.
  • Author impact assessments to support deviations and change controls.
  • Provide technical assistance for process-related deviations and collaborate with manufacturing teams.
  • Engage in process improvement initiatives involving cross-functional teams.
  • Conduct risk assessments and investigations, employing systematic approaches and industry best practices.
  • Identify corrective and preventative actions for process-related issues.
  • Facilitate technology transfers and oversee verification runs.
  • Participate in process Failure Mode and Effects Analysis (FMEA).
  • Contribute to cross-functional development teams to advance production activities.
  • Ensure successful manufacturing runs by assessing risks and troubleshooting equipment and process challenges.
  • Perform additional duties as required.

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 complexities of cell therapy-based therapeutics.
  • Able to manage competing priorities effectively in a dynamic environment.
  • Prior experience in GMP manufacturing to support person-in-plant operations.
  • Experience in managing relationships with external partners, demonstrating strong communication skills.
  • Willingness to travel as necessary to fulfill job responsibilities.
  • Experience in Process Development, Manufacturing, or MSAT for cell or gene therapies is preferred.
  • Excellent written and verbal communication skills.
  • Strong interpersonal skills with a communication style that reflects respect and transparency.
  • This position is open to remote candidates within North America.

Compensation/Benefits:

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

  • 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: Options for flexible schedules and remote work.

Turnstone Biologics is committed to inclusivity and encourages applications from individuals with disabilities. Accommodations are available upon request for candidates participating in the selection process. We appreciate all applicants for their interest.