Manufacturing Associate (1st Shift)
Posted on: September 22, 2022
POSITION DESCRIPTION / DEPARTMENT OVERVIEW
As part of the Sanofi Genomic Medicine Unit organization in
Framingham, the Cell Therapy Manufacturing Suite (CTMS) is
responsible to support manufacturing of cutting-edge biologic drug
substance material to support clinical candidate programs. The CTMS
group operates in clean-room production suites under cGMP
conditions to produce cell therapy products suitable for use in
First in Human stage clinical trials. CTMS also interacts closely
with the Quality Assurance (QA), Bioprocess Engineering,
Validation, and other groups to ensure cGMPs and manufacturing
schedules are maintained. Operations' main functions are the
execution of manufacturing campaigns, leading deviation
investigations and managing CAPA implementation, partnering with
direct manufacturing staff for enhancing and improving the
manufacturing instruction set, overseeing and supporting
manufacturing's training program, and identifying and managing
continuous improvement initiatives.
This role is first shift: Sunday to Wednesday 7am-5:30pm OR
Wednesday to Saturday 7am-5:30pm.
* Practices safe work habits and adheres to Sanofi's safety
procedures and guidelines.
* Participates in On-the floor participation of upstream and/or
downstream activities for executing manufacturing campaigns in a
multi-product GMP facility Follows standard operating procedures
and/or batch documents to execute activities.
* Assists with adapting new and existing equipment to new processes
developed for each drug candidate
* Participates on cross functional teams and drives investigation
close outs, determines root-cause and implements appropriate
Corrective and Preventative Action.
* Utilizes manufacturing process knowledge and investigation skill
sets to identify and resolve manufacturing issues, improve process
operations and affect positive change.
* Assists with document revisions and/or document management
including batch production records, and manufacturing
* Authors or revises standard operating procedures to improve
compliance and efficiencies.
* Assists manufacturing managers and supervisors to develop and
maintain training materials on process operations, theory, and
* Performs training with staff on the floor, as needed.
* Participates on cross-functional continuous improvement teams
with Engineering, Validation, Quality Assurance, Quality Control,
Facilities, Metrology, and Manufacturing Technical Services.
* Works under general supervision and direction.
* Participates in determining objectives of assignment.
* Performs work that may require independent decision making and
the exercise of independent Judgement and discretion.
* High school diploma/GED or Biotech Certification with 3-5 years
of experience in cGXP manufacturing environment, or Bachelor's
Degree with 1-3 years of experience.
* Knowledge of Cell Therapy manufacturing.
* Understanding of GXP and how it applies to specific
* Excellent written and oral English language skills.
* Bachelor's degree in Biology, Chemistry, Biochemistry, or
* Experience authoring and reviewing standard operating procedures,
on-the-job trainings, and other controlled documents.
* Familiarity with Controlled document systems.
* Experience operating in gowning and clean room environments
* Experience in troubles shooting investigation, and root cause
analysis in a GXP environment.
* Experience with deviation or investigation management
SPECIAL WORKING CONDITIONS
* Ability to gown and gain entry to manufacturing areas.
* Ability to lift 30 lbs.
At Sanofi R&D North America, we deliver meaningful solutions
for patients. We transform science into breakthrough, best-in-class
and first-in-class medicines and vaccines. We believe in creating a
diverse and inclusive workforce - and workplace - which brings
together the collective brainpower of over 2,000 colleagues and
provides you with an exciting place to grow and develop. We set the
bar high, and we deliver. Join us and together we will build on our
trusted legacy of breakthroughs for society.
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.
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 responsibilities.
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 START DATE.
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, Framingham , Manufacturing Associate (1st Shift), Other , Framingham, Massachusetts
Didn't find what you're looking for? Search again!