MST Process Engineer III (Upstream)

Thermo Fisher Scientific-Viral Vector Services (VVS) is a rapidly growing, dynamic 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 groundbreaking 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 proficiencies and strong character to join our team and help lead our organization into the future.

How will you make an impact?

The MST Upstream Process Engineer will be responsible for implementation of robust, scalable and efficient manufacturing processes through leading technology transfer, Process Validation, late stage clinical and commercial manufacturing technical support activities. The individual will provide technical expertise and leadership and requires close collaboration with throughout the organization.

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 Upstream process, ensuring the required materials and documentation are in place.
  • 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’ experience, or PhD with 1+ years’ experience.

Experience

  • Technical expertise in upstream biopharmaceutical manufacturing, technical process support and/or process development.
  • Experience with adherent mammalian cells (preferably HEK).
  • Knowledge of Stirred Tank Bioreactors, flat stock technology including Cellstacks, Hyperstacks and iCellis systems.
  • 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.

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.
  • Off hours and weekend technical support may be required for studies and manufacturing operations.
Posted
10/04/2021
Salary Range
$71,000.00 - 96,000.00
per Year
Salary range estimated by
Location
Lexington, MA 02173, US
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