MST Process Engineer III (Drug Product) (Viral Vector Services)
Company: Thermo Fisher Scientific
Posted on: November 22, 2021
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
- Includes authoring detailed process definition and facility fit
- 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
- 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
- Expertise in biologics manufacturing or virology including
technical topics in aseptic manufacturing and sterile
- 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
- Experience in manufacturing operations, engineering, MST roles
is highly valued.Knowledge, Skills, Abilities
- Working knowledge of quality and compliance aspects of
- Knowledge of cell and gene therapy vector production is highly
- 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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