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Manufacturing Science

2 months ago

California, United States Turnstone Biologics Full time

Turnstone Biologics is on the lookout for a motivated and skilled Process Engineer to join our Manufacturing Science & Technology (MSAT) team. This pivotal role involves providing technical and scientific expertise to enhance our manufacturing network, specifically focusing on the TIDAL-01 operations process. Responsibilities include:

  • Leading or assisting in technology transfers and offering Person-In-Plant (PIP) support.
  • Conducting root cause analyses and impact assessments to drive process improvements.
  • Monitoring processes to ensure optimal performance and compliance.

The ideal candidate will thrive in a fast-paced environment, demonstrating attention to detail while contributing to the delivery of innovative therapies to patients.

Key Responsibilities:

  • Engage with manufacturing leadership to provide strategic and technical guidance for clinical production.
  • Serve as a Subject Matter Expert (SME) for GMP operations at Contract Manufacturing Organizations (CMOs).
  • Support investigations of process deviations and implement corrective actions.
  • Collaborate with Process Development teams to optimize processes and integrate new technologies.
  • Manage change controls related to processes and materials.
  • Draft and review essential technical documentation, including batch records and SOPs.
  • Analyze data from clinical manufacturing processes to inform decision-making.
  • Facilitate data collection and management for manufacturing processes.
  • Prepare impact assessments for deviations and change controls.
  • Provide technical support for process-related deviations.
  • Lead process improvement initiatives with cross-functional teams.
  • Conduct risk assessments and root cause analyses using industry best practices.
  • Determine corrective and preventative actions for process deviations.
  • Assist in technology transfers and verification runs.
  • Participate in process Failure Mode and Effects Analysis (FMEA).
  • Contribute to cross-functional development teams to enhance production activities.
  • Ensure successful manufacturing runs by assessing risks and troubleshooting issues.
  • Perform additional duties as assigned.

Qualifications:

  • Bachelor's degree in life sciences, engineering, or a related field with a minimum of 4 years of industry experience; or a Master's degree with 3+ years; or a PhD with 1+ year of experience.
  • At least 3 years of experience in the manufacturing and operational complexities of cell therapy-based therapeutics.
  • Adept at managing competing priorities in a dynamic environment.
  • Experience with GMP manufacturing processes.
  • Proven ability to manage relationships with external partners effectively.
  • 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 respectful and transparent communication style.

Compensation and Benefits:

At Turnstone, we value the well-being and success of our employees. We offer a competitive compensation package that includes:

  • Healthcare Coverage: Comprehensive medical, dental, and vision insurance.
  • Retirement Planning: 401(k) plan with employer contributions.
  • Generous Paid Time Off: Including vacation, sick leave, and holidays.
  • Workplace Flexibility: Options for flexible schedules and remote work.

Turnstone Biologics is committed to fostering an inclusive environment and encourages applications from individuals with disabilities. Accommodations are available upon request during the selection process.