Manager Senior Scientist

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Manager Senior Scientist','POS_75033954-1','!*! Manager, Sr. Scientist (Biologics or Engineering)

The Industrial Operations
(IO) site at Swiftwater, Pennsylvania, one of the largest vaccine manufacturing
sites in the USA, continues to develop its manufacturing assets for existing
and new vaccines and biopharmaceuticals. IO provides a variety of development
opportunities to our associates on the job through diverse roles across many
functions, on-site resources for continuous learning and off-site access to
further education.

The Position

This position of
Industrial Operations Manager, Senior Scientist, in the Manufacturing
Technology (Mtech) function of Industrial Operations, participates in the
execution of technical studies to industrialize viral processes for Phase 3 and
licensed production. The mission of MTech is to deliver robust and efficient
process & testing with associated know-how transfer to Manufacturing &
Quality Control (QC). Mtech’s function also provides daily support, for
manufacturing and QC, toward industrial performance excellence.

Swiftwater IO conducts and
optimizes activities in area of specialization with high technical and
scientific complexity. The Industrial Operations Downstream Protein
Purification Scientist is responsible for development, scale-up and validation
of downstream processes for biomolecules as well as definition of critical
process parameters. The individual in this position will contribute to
cross-functional teams from various functions in IO to meet project objectives
and deliver the following:

Accountabilities:

* Provide validated,
efficient, safe and regulatory compliant downstream processes for proteins to
manufacturing / production groups.

* Lead and supervise the
design, documentation and execution of investigation, definition, engineering,
and process validation studies at bench and manufacturing scales.

* Interpret and
communicate study results within the platform or project.

* Provide technical
expertise and act as a subject matter expert for downstream protein
purification which includes development, scale-up and validation.

* Author, train
technicians, and execute risk analyses, protocols, BPR’s and reports.

The Job Responsibilities
Include:

* Apply risk based and Qbd
approaches for downstream process development & validation and process
control strategy definition.

* Cooperate transversally
and lead cross functional teams to complete validation of efficient and robust
downstream processes to the manufacturing groups.

* Design, lead and execute
bench scale studies to help define process control and validation parameter
ranges.

* Work closely with and
lead technicians and teams in support of validation and processing issues.

* Critically design
studies and analyze data from complex systems to recommend and present
effective problem resolution.

* Implement a hands on
approach in leading design and execution of investigational, definition,
engineering and validation studies.

* Maintain up to date
knowledge in downstream process validation advancements and regulatory trends
in order to implement innovative solutions to validation issues.

* Comply with cGMP and
other internal and external quality and regulatory guidance.

* Support health authority
inspections and follow up actions.

* Comply with health and
safety guidelines.



','!*!Manager, Sr. Scientist (Biologics or Engineering) The Industrial Operations
(IO) site at Swiftwater, Pennsylvania, one of the largest vaccine manufacturing
sites in the USA, continues to develop its manufacturing assets for existing
and new vaccines and biopharmaceuticals. IO provides a variety of development
opportunities to our associates on the job through diverse roles across many
functions, on-site resources for continuous learning and off-site access to
further education. The PositionThis position of
Industrial Operations Manager, Senior Scientist, in the Manufacturing
Technology (Mtech) function of Industrial Operations, participates in the
execution of technical studies to industrialize viral processes for Phase 3 and
licensed production. The mission of MTech is to deliver robust and efficient
process & testing with associated know-how transfer to Manufacturing &
Quality Control (QC). Mtech’s function also provides daily support, for
manufacturing and QC, toward industrial performance excellence.Swiftwater IO conducts and
optimizes activities in area of specialization with high technical and
scientific complexity. The Industrial Operations Downstream Protein
Purification Scientist is responsible for development, scale-up and validation
of downstream processes for biomolecules as well as definition of critical
process parameters. The individual in this position will contribute to
cross-functional teams from various functions in IO to meet project objectives
and deliver the following:Accountabilities:* Provide validated,
efficient, safe and regulatory compliant downstream processes for proteins to
manufacturing / production groups.* Lead and supervise the
design, documentation and execution of investigation, definition, engineering,
and process validation studies at bench and manufacturing scales.* Interpret and
communicate study results within the platform or project.* Provide technical
expertise and act as a subject matter expert for downstream protein
purification which includes development, scale-up and validation.* Author, train
technicians, and execute risk analyses, protocols, BPR’s and reports. The Job Responsibilities
Include:* Apply risk based and Qbd
approaches for downstream process development & validation and process
control strategy definition.* Cooperate transversally
and lead cross functional teams to complete validation of efficient and robust
downstream processes to the manufacturing groups.* Design, lead and execute
bench scale studies to help define process control and validation parameter
ranges.* Work closely with and
lead technicians and teams in support of validation and processing issues.* Critically design
studies and analyze data from complex systems to recommend and present
effective problem resolution.* Implement a hands on
approach in leading design and execution of investigational, definition,
engineering and validation studies.* Maintain up to date
knowledge in downstream process validation advancements and regulatory trends
in order to implement innovative solutions to validation issues.* Comply with cGMP and
other internal and external quality and regulatory guidance.* Support health authority
inspections and follow up actions.* Comply with health and
safety guidelines. Who You AreYou are inspired by Sanofi
Pasteur’s IO mission to improve worldwide human health, as a reliable
manufacturer, by delivering high quality, innovative, and affordable products
to our customers. You would fit in well with our Sanofi values of innovation, solidarity,
confidence, respect, and integrity and our ways of working (Focus, Agility,
Accountability and Simplicity). Education and experience Basic Qualifications:* BS or MS in Biological
sciences or engineering with a minimum of 5-6 years of industry experience. PhD
with a minimum of 1 year of industry experience. Preferred Skills:* Demonstrated expertise
in development & validation of downstream processes for transmembrane
proteins.* Demonstrated expertise
in study design and execution for proteins* Demonstrated expertise
in applying risk based and Qbd approaches to establish process validation and
process control strategies* Demonstrated experience
in scale-down model design, execution and qualification* Hands on experience in
downstream processing of proteins and at bench and manufacturing scales* GMP processing
experience* Demonstrated skill in
leading teams and making decisions that impact department and project
objectives under time constraints* Demonstrated strong
communication (oral and written), interpersonal, and interdisciplinary skills,
and ability to effectively communicate goals and objectives to all relevant
stakeholders. #LI-SP

','Laboratory/Process/Device Development','United States-Pennsylvania-Swiftwater','','Oct 13, 2025','Regular','Regular','Manager Senior Scientist']);
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