Upstream Manufacturing Associate
Company: Sanofi Group
Posted on: September 20, 2022
****12-hour day shift positions- including rotating holidays,
weekends, and overtime as per business needs****
****Cell Culture experience****
Sanofi has pioneered the development and delivery of transformative
therapies for patients affected by rare and debilitating diseases
for over 30 years. We accomplish our goals through world-class
research, collaboration with the global patient community, and with
the compassion and commitment of our employees. With a focus on
rare diseases and multiple sclerosis, we are dedicated to making a
positive impact on the lives of the patients and families we serve.
Sanofi's portfolio of transformative therapies, which are marketed
in countries around the world, represent groundbreaking and
life-saving advances in medicine. Sanofi benefits from the reach
and resources of one of the world's largest pharmaceutical
companies, with a shared commitment to improving the lives of
Sanofi, an integrated global healthcare leader, discovers,
develops, and distributes therapeutic solutions focused on
patients' needs. Sanofi has core strengths in the field of
healthcare with seven growth platforms: diabetes solutions, human
vaccines, innovative drugs, consumer healthcare, emerging markets,
and animal health.
The Upstream Manufacturing Department performs small and
large-scale cell culture operations, harvest filtration, and
initial capture chromatography steps in a new manufacturing
facility. The 24/7 large-scale therapeutic protein manufacturing
facility uses single-use technology. The Upstream Department is
responsible for all setup, operation, and breakdown of equipment
associated with cell culture and capture column operations.
This position is responsible for performing a variety of complex
tasks under the general guidance and in accordance with the
manufacturing instruction set and current GMPs.
+ Practices and promotes safe work habits and adheres to Sanofi's
safety procedures and guidelines.
+ Effectively demonstrates an understanding of GMPs and how they
apply to specific responsibilities.
+ Follows verbal and written procedures in operating production
equipment and performing processing steps; accurately completes
appropriate production documentation.
+ Identifies escalates, and documents events and subtle variances
that deviate from normal operation; participate as needed in
+ Maintains cleanliness and orderliness of process area.
+ Ensures production area is stocked with supplies.
+ Prepare and operate seed train, bioreactor, and chromatography
+ Performs clean in place and steam in place operations to prepare
equipment for manufacturing operations.
+ Performs batch record review, procedure revisions, and work order
+ Fulfills role of the lead trainer on numerous operations and is
an area SME.
+ Utilizes manufacturing knowledge to improve process operations
and affect positive change.
+ Demonstrates ability to troubleshoot basic mechanical
+ Effectively utilizes Microsoft office applications.
+ Mentors less experienced operators and performs support functions
+ Leads teams to the execution of the daily work plan.
+ May attend scheduling and MDI meetings in absence of
+ May lead shift handover or act as a shift lead in the absence of
An ongoing commitment to conducting our global business according
to the highest legal and ethical standards, and to continually
pursue excellence in the development and delivery of all of our
products and services. This includes:
+ Adhering to all applicable laws and regulations of the places in
which we conduct business, as well as our own Company policies and
+ Being honest and treating people with respect and courtesy.
+ Constantly striving to make Sanofi a great place to work, and a
company respected for the quality of its people and products.
+ Acting as role models for our fellow employees by acting
responsibly, fairly, and honestly in our dealings and exercising
sound judgment in performing our jobs.
+ High school diploma/GED with 3-5 years of experience in cGXP
manufacturing environment, or Bachelor's degree with 1-3 years of
+ Bachelor's degree with 2-4 years of experience in bulk biologics
+ Familiarity with Manufacturing Control Systems (i.e. DeltaV).
+ Extended experience with cell culture operations.
+ Experience in a GXP environment.
+ Experience facilitating and delivering training.
+ Experience in creating controlled documents.
**SPECIAL WORKING CONDITIONS:**
+ Ability to lift up to 50 lbs.
+ Ability to stand on average 10 hours per shift.
+ Ability to gown and gain entry to manufacturing areas (8 NYA site
requires changing into scrubs).
+ Ability to work a twelve-hour rotating shift every other weekend,
including scheduled holidays.
+ Ability to work in a cold room environment (2-10 degrees C)
**_As a healthcare company and a vaccine manufacturer, Sanofi has
an important responsibility to protect individual and public
health. All US based roles require individuals to be fully
vaccinated against COVID-19 as part of your job
**_Fully vaccinated, according to the CDC, an individual is
considered to be "fully vaccinated" fourteen (14) days after
receiving (a) the second dose of the Moderna or Pfizer vaccine, or
(b) the single dose of the J&J vaccine. Fully vaccinated, for
new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO
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.
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
Keywords: Sanofi Group, Framingham , Upstream Manufacturing Associate, Other , Framingham, Massachusetts
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