Manufacturing Science Process Engineer

2 weeks ago

California, United States Turnstone Biologics Full time

Position Overview

Turnstone Biologics is on the lookout for a dedicated and skilled Process Engineer to enhance the Manufacturing Science & Technology (MSAT) Team. This role is pivotal in providing technical and scientific assistance to the Turnstone manufacturing network, specifically focusing on the TIDAL-01 operations process. Responsibilities include leading or assisting in technology transfers, providing Person-In-Plant (PIP) support, conducting root cause analyses, performing impact assessments, implementing process enhancements, and monitoring processes.

Key Responsibilities

  • Engage with Manufacturing leadership to offer 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 of process deviations and impact assessments, determining 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 related to processes and 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 advance production activities.
  • Ensure successful manufacturing production runs by assessing risks, implementing preventative measures, and troubleshooting equipment and process issues.
  • Additional responsibilities as assigned.

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.
  • 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 external relationships with CMO partners or clients, demonstrating mature and thoughtful communication to foster strong partnerships.
  • Willingness to travel to fulfill job 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 Turnstone's values: respectful, transparent, and consistent.

Compensation and 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 encompass:

  • 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 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, but only those selected will be contacted for an interview.

  • Manufacturing Science Process Engineer

    1 week ago

    California, United States Turnstone Biologics Full time

    Position OverviewTurnstone Biologics is in search of a motivated and skilled Process Engineer to enhance the Manufacturing Science & Technology Team (MSAT). The ideal candidate will provide essential technical and scientific support for the TIDAL-01 operations process, which includes leading or assisting in technology transfers, Person-In-Plant (PIP)...

  • 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...

  • Manufacturing Science Process Engineer

    2 weeks 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...

  • Manufacturing Science

    1 week 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...

  • Manufacturing Science

    2 weeks 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...

  • Manufacturing Process Engineer

    2 weeks ago

    California, United States Glacier Full time

    Company Overview:At Glacier, we are tackling one of the most significant challenges of our time: waste management. In the United States, over half of recyclable materials end up in landfills. Our mission is to change that. By doing so, we aim to reduce carbon emissions, conserve energy, and protect our natural resources.Glacier develops innovative sorting...

  • Manufacturing Process Engineer

    1 week ago

    California, United States Glacier Full time

    About Glacier:At Glacier, we are tackling one of the most significant challenges of our time: waste management. In the United States, over half of our recyclable materials end up in landfills. Our mission is to change that. By doing so, we aim to lower carbon emissions, reduce energy consumption, and conserve natural resources.Glacier specializes in creating...

  • Manufacturing Process Engineer

    2 weeks ago

    California, United States Glacier Full time

    Company Overview:At Glacier, we are addressing one of the most critical challenges of our time: waste management. In the United States, a significant portion of recyclable materials ends up in landfills. Our mission is to change this narrative. By doing so, we aim to lower carbon emissions, conserve energy, and protect our natural resources.Glacier...

  • Manufacturing Process Engineer

    1 week ago

    California, United States Glacier Full time

    Company Overview:At Glacier, we are addressing one of the most critical challenges of our time: waste management. In the United States, over half of our recyclable materials end up in landfills. Our mission is to change that narrative. By doing so, we aim to lower carbon emissions, conserve energy, and protect our natural resources.Glacier develops...

  • Manufacturing Process Engineer

    2 weeks ago

    California, United States Glacier Full time

    Company Overview:At Glacier, we are tackling one of the most critical challenges of our time: waste management. In the United States, over half of recyclable materials end up in landfills. Our mission is to change that, significantly reducing carbon emissions, conserving energy, and preserving natural resources.Glacier develops innovative sorting robots that...

  • Manufacturing Process Engineer

    2 weeks ago

    California, United States Glacier Full time

    Company Overview:At Glacier, we are tackling one of the most significant challenges of our time: waste management. In the United States, over half of recyclable materials end up in landfills. Our mission is to change that narrative. By doing so, we aim to lower carbon emissions, conserve energy, and protect our natural resources.Glacier develops bespoke...

  • Manufacturing Process Engineer

    2 days ago

    California, United States Softworld, a Kelly Company Full time

    Job Title: Manufacturing Process EngineerJob Summary:We are seeking a highly skilled Manufacturing Process Engineer to join our team at Softworld, a Kelly Company.The ideal candidate will have a strong background in manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, fabrication, and material...

  • Manufacturing Process Engineer

    6 days ago

    California, United States saint_gobain_group Full time

    About the RoleThis position is responsible for developing and optimizing continuous production and manufacturing processes to achieve the output, quality, and cost goals of the organization.Key ResponsibilitiesCollect production data and apply standard scientific and statistical methods to analyze, document, and diagram production processes.Establish...

  • Manufacturing Process Engineer

    1 week ago

    Carlsbad, California, United States FRONTGRADE TECHNOLOGIES Full time

    About UsFrontgrade Technologies is the leading provider of analog and radiation hardened technology for the United States aerospace and defense industry.We develop high-performing electronic solutions that meet the most stringent requirements, ensuring our customers' success in human spaceflight, space exploration, missile defense, electronic warfare, and...

  • Manufacturing Process Engineer

    2 weeks ago

    Carlsbad, California, United States FRONTGRADE TECHNOLOGIES Full time

    About UsFrontgrade Technologies is the leading provider of analog and radiation hardened technology for the United States aerospace and defense industry.We develop high-performance electronic solutions that meet the most stringent requirements, ensuring reliability and efficiency in critical applications.Job SummaryWe are seeking a skilled Manufacturing...

  • Manufacturing Process Specialist

    2 weeks ago

    California, Maryland, United States Pharmavite LLC Full time

    JOIN US IN ENHANCING HEALTH AND WELLNESS. At Pharmavite, we offer a unique experience that prioritizes complete nutrition for everyone. Each project is critical, and every day matters. You will have the chance to contribute to the leading national vitamin and supplement brand, Nature Made, along with a diverse range of products that are revolutionizing the...

  • Associate Director, Manufacturing Science

    4 weeks ago

    California, United States Insmed Incorporated Full time

    Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are...

  • Associate Director, Manufacturing Science

    1 month ago

    California, United States Insmed Incorporated Full time

    Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are...

  • Senior Process Engineer

    2 weeks ago

    California, Missouri, United States Primary Talent Partners, Inc. Full time

    Position Overview:Primary Talent Partners is seeking a Senior Process Engineer for a contract opportunity with a leading global medical device organization. This role will be based onsite and is focused on enhancing manufacturing operations.Compensation: Competitive hourly rate ranging from $60.00 to $70.00, commensurate with experience.Contract duration is...

  • Process Engineer

    4 weeks ago

    California, United States Pharmavite Full time

    HELP US BRING THE GIFT OF HEALTH TO LIFE.Working at Pharmavite is an experience like no other. With a focus on complete nutrition for all, each endeavor is urgent and every day counts. You'll have the opportunity to work on the #1 selling national vitamin and supplement brand, Nature Made, as well as an exciting portfolio of other products that are shaping...