Senior Process Engineer - Purification Tech Transfer and Pro
Company: Sanofi
Location: Framingham
Posted on: February 25, 2021
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Job Description:
The health and safety of our employees and candidates is very
important to us. Due to the current situation related to
the--Coronavirus (COVID-19), we're leveraging our digital
capabilities to ensure we can continue to recruit top talent. As
your application progresses, you may be asked to use one of our
digital tools to help you through your recruitment journey. If so,
one of our--colleagues will explain how these tools will be used
throughout the recruitment process and will be on hand to answer
any questions you might have. Senior Process Engineer -
Purification Tech Transfer and Production Support From Research and
Development to Sales and Marketing, Sanofi offers a wide range of
possibilities. Discover our open positions and become a health
journey partner. Do you have what it takes for a successful career
with Sanofi? This role is accountable for rigorous and efficient
transfer and implementation of purification processes across the
Sanofi GMP manufacturing network according to the--program
timelines. The role of the BioProcess Engineering (BPE) group is to
serve as a general lead for clinical transfers and sending lead for
commercial transfers. Responsibilities: Responsibilities include
but are not limited to partner with all relevant functions from
R&D and IA to perform facility fit assessment, GMP operational
readiness assessment, and authorize transfer documents,
specifically: Lead technical transfer activities including
facility-fit assessment and operational readiness assessment and
provide technical support as SME for purification processes.
Support GMP manufacturing operations: Serve as People-In Plant
(PIP) for critical steps during manufacturing campaigns Organize
regular review meetings during GMP campaigns with updates on
process performance and deviations Act as technical leader for
deviations and CAPA definition to resolve complex process
anomalies-- Lead authorization of technology transfer plans and
technology transfer reports Partner of risk assessment and control
strategy definition by providing information and data on facility
and equipment capability and constraints Act as a data steward by
gathering and compiling process data for projects with the support
of all involved functions (Development, GMP manufacturing, and
Analytics) for development runs, scale-up batches at technical
pilot plant, and GMP batches at GMP manufacturing including process
performance attributes and analytical results. Visualization for
reviews, assessments, and process anomaly root cause analysis Lead
evaluation and implementation of new process platforms and
manufacturing technologies As a senior member of the BPE group,
work collaboratively with members of other functions to streamline
the interfaces with various partners and represent the function in
stakeholder meetings as needed. Along with BPE members at other
sites, maintain and update the knowledge base of equipment and
operation specifications across the entire Sanofi manufacturing
network. Share best practices in tech transfer and implementation
and drive continuously improvement. Basic Qualifications: PhD in
Chemical Engineering, Biochemistry, Biotechnology, or related
discipline with minimum of 4 years or Master's degree with 8 years
or Bachelor's with 10 years of industrial experience in
manufacturing and/or process development of biologics Experience in
leading matrix teams. Excellent oral and written communication
skills to build relationships both inside and outside the company.
Experience working on multiple complex projects to aggressive
timelines with the ability to adapt to rapid changes in project
priorities. Preferred Qualifications: Experience in manufacturing
or process development of biologics, preferred produced in
recombinant protein purification systems, with knowledge on
scale-up, process transfer, and cGMP manufacturing operation.
Experience in writing and revising protocols, procedures, reports
and other process related documentation as necessary to support
process scale-up, transfer, and implementation to cGMP
manufacturing operations Working knowledge in recombinant protein
GMP manufacturing, quality standards, and regulatory requirements
Experience in defining process control strategy and process
validation and performing risk assessment following the QbD
principle Special Working Conditions: Ability to gown and work in
manufacturing areas Ability to work flexible hours Sanofi Inc. and
its U.S. affiliates are Equal Opportunity and Affirmative Action
employers committed to a culturally diverse workforce. All
qualified applicants will receive consideration for employment
without regard to race; color; creed; religion; national origin;
age; ancestry; nationality; marital, domestic partnership or civil
union status; sex, gender, gender identity or expression;
affectional or sexual orientation; disability; veteran or military
status or liability for military status; domestic violence victim
status; atypical cellular or blood trait; genetic information
(including the refusal to submit to genetic testing) or any other
characteristic protected by law. #GD-SA #LI-SA At Sanofi diversity
and inclusion is foundational to how we operate and embedded in our
Core Values. We recognize to truly tap into the richness diversity
brings we must lead with inclusion and have a workplace where those
differences can thrive and be leveraged to empower the lives of our
colleagues, patients and customers. We respect and celebrate the
diversity of our people, their backgrounds and experiences and
provide equal opportunity for all. Join our Talent Network and get
Sanofi communications delivered to your inbox. By submitting your
information, you acknowledge that you have read our privacy policy
and consent to receive email communication from Sanofi.
Keywords: Sanofi, Framingham , Senior Process Engineer - Purification Tech Transfer and Pro, Engineering , Framingham, Massachusetts
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