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MST Process Engineer III (Drug Product) (Viral Vector Services)

Company: Thermo Fisher Scientific
Location: Lexington
Posted on: November 22, 2021

Job Description:

Thermo Fisher Scientific-Viral Vector Services (VVS) is a rapidly growing, multifaceted gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.How will you make an impact?The MST Drug Product Process Engineer will be responsible for technical support and execution for late stage clinical and commercial gene therapy manufacturing. From technology transfer through process performance qualification, process engineers are responsible for keeping technical deliverables on track and driving process improvements. The individual will provide technical expertise and leadership and requires participation with cross functional technology transfer teams for ENG /cGMP Drug product (or Fill finish) manufacturing of viral vectors. The individual will collaborate with another site or clients to ensure success of scale up/ process transfer.What will you do?

  • Lead technology transfer for the implementation and production of viral vectors.
    • Collaborate with other sites or clients to ensure success of process transfer and scale up.
    • Ensure effective information flow, risk assessment, timeline execution, issue resolution and documentation for multi-functional teams.
    • Includes authoring detailed process definition and facility fit assessment exercises.
    • MST process lead for Drug Product process, ensuring the required materials and documentation are in place.
    • Provide on-the-floor technical and scientific support for critical manufacturing operations.
    • Collaborate with PS/PD/QC/QA to develop testing strategy for raw materials and process intermediates. Maintains good laboratory practices.
    • Execute process establishment runs and small-scale experiments, ensuring the materials, strategies are properly designed and aligned to achieve the desired results.
    • Author and maintain process control strategy documents throughout the lifecycle of a program.
    • Provide leadership and execution of risk assessment activities and associated documentation.
    • Coordinate execution of PPQ and PPQ related activities.
    • Support engineering teams on equipment selection, qualification, and start up activities.
    • Develop sampling plans with clients and incorporate them into cGMP batch documentation.
    • Oversee the monitoring and trending of process performance, including input and output parameters.
    • Investigate root causes of major deviations for cGMP manufacturing, provide product quality impact assessments and implement CAPA for major deviations.
    • Finding opportunities to improve systems and practices.
    • Work with counterparts in Process Development, Process Sciences, Manufacturing, Quality, Project Management teams etc. to facilitate technology transfer and project success.Education
      • Bachelor's degree required in biochemical engineering, chemical engineering or related scientific field such as molecular biology, virology, biochemistry. Advanced degree preferred.
      • B.S. with 5+ years, Master's degree with 2+ years, or PhD with 1+ years experience.Experience
        • Technical expertise in drug product biopharmaceutical manufacturing, technical process support and/or process development.
        • Expertise in biologics manufacturing or virology including technical topics in aseptic manufacturing and sterile fill-finish.
        • Knowledge of aseptic filling, visual inspection, container closure integrity testing, extractable and leachable assessments, labeling and packaging.
        • Expertise in late stage/commercial technology transfer, process characterization and process validation of gene therapy/viral vector manufacturing processes preferred.
        • Solid understanding of GMP and regulatory requirements of biopharmaceutical manufacturing.
        • Experience in manufacturing operations, engineering, MST roles is highly valued.Knowledge, Skills, Abilities
          • Working knowledge of quality and compliance aspects of biopharmaceutical manufacturing.
          • Knowledge of cell and gene therapy vector production is highly desirable.
          • Ability to work both independently and as part of a team.
          • Ability to function in a fast-paced diverse team environment and balance prioritize different projects.
          • Project management skills desirable.
          • Laboratory skills and the ability to be hands-on.
          • Ability to speak effectively before groups of customers.
          • Excellent troubleshooting skills and ability to solve complex technical issues. Ability to compile, analyze and interpret data; Ability to write routine reports and correspondence.
          • Strong interpersonal and communication skills, verbal and written. Ability to speak effectively before groups of customers. Ability to communicate in a dynamic environment

Keywords: Thermo Fisher Scientific, Boston , MST Process Engineer III (Drug Product) (Viral Vector Services), Engineering , Lexington, Massachusetts

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