Manufacturing Manager Clinical Cell Therapy
Company: Sanofi
Location: Framingham
Posted on: June 25, 2022
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Job Description:
PositionOverview:Sanofi's Genomic Medicine Unit (GMU) CMC group
is dedicated to the establishment of best in class manufacturing
platforms to support development of life-changing advanced cell and
gene therapy products, including recombinant AAV vectors,
lentiviral vectors, and cell therapy products. Sanofi is looking
for a cell therapy leader with GMP manufacturing expertise to serve
as Manager of Clinical Cell Therapy Manufacturing. This is an
exciting opportunity to join Sanofi's GMU and be part of building
the company's cell therapy manufacturing strategy. The ideal
candidate will have expertise in cell therapy manufacturing with a
demonstrated track record of successful development-to-clinical
product transitions. Creativity, scientific thoroughness,
entrepreneurial mindset, and ability to function in a complex
environment are essential.Key Responsibilities:The primary
accountability of this role is to enable the manufacturing of cell
therapy products for clinical supply, as a cell therapy technical
expert for cGMP manufacturing, through providing hands-on technical
leadership and operational oversight for a cell therapy
manufacturing suite in Framingham, MA. We are looking for a
candidate with excellent GMP, scientific, technical, communication,
and leadership skills.Specifically:Provide leadership to oversee
the operation of a GMP cell therapy manufacturing operations
team.Manage operational staff, including developing staff
capabilities through initial and ongoing training and maintaining
team compliance.Provide management oversight of tech transfer
activities.Provide management oversight of drug products
production.Manage the production schedule and the daily tasks of
the Manufacturing Operators.Provide oversight and guidance related
to training materials, SOPs, batch records, reports, risk
assessments, materials management, etc.Work cross-functionally with
process development, quality, and other counterparts for the
development of next-generation cGMP cell therapy manufacturing
processes.Works closely with senior management to initiate new
projects and assist in developing processes/techniques to meet
business objectives.Basic Qualifications:Bachelor's degree in
sciences, engineering or related discipline with a minimum of 8
years of industry experience or a Master's degree with a minimum of
6 years of industry experience.A minimum of 2 years managing direct
reports or project teams.Experience in GMP documentation and
compliance.Ability to operate and thrive in a fast-paced,
high-growth environment.Strong skills in change
management.Excellent communication skills.Preferred
Qualifications:Cell Therapy experiencePhD in a sciences or
engineering discipline.Direct experience in cell GMP manufacturing
facilities with expertise in CAR-T, NK cell therapy.Involvement in
delivering a cell therapy-based product into clinical
development.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. GD-SALI-SAPDNAt 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.PDN-968f567d-06ba-4154-b760-bab667513921
Keywords: Sanofi, Framingham , Manufacturing Manager Clinical Cell Therapy, Healthcare , Framingham, Massachusetts
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