Senior Scientist
Company: Sanofi
Location: Framingham
Posted on: January 27, 2023
|
|
Job Description:
Senior Scientist, Upstream MSAT
DEPARTMENT DESCRIPTION:
The Senior Scientist position is part of the Upstream team in the
drug substance function within global Manufacturing Science &
Technology (MSAT) and is based at the biologics hub in Framingham,
MA. The MSAT mission is to enable the reliable supply of SC
(Specialty Care) medicines by providing expert technical and
scientific support to their licensure, ongoing commercial
manufacturing, and life-cycle management activities.
The drug substance (DS) function within global MSAT is the owner of
Life Cycle Management (LCM) of DS processes within the Sanofi
biologics manufacturing network. We deliver innovative, robust, and
cost-effective next generation processes and provide commercial
manufacturing support. The function is responsible for tech
transfer activities including process-fit gap assessment, process
validation, dossier preparation, & PAI support to enable launch of
new and LCM products. Our expansive portfolio covers 17 products, 5
modalities, 3 expression systems within 12 internal and external
global sites in the US and EU. We will be supporting launch of 20
new products in the next 5 years including monoclonal and
multi-specific antibodies, fusion proteins, antibody-drug
conjugates, synthorins, and nanobodies. In recent years we have
successfully established second-generation manufacturing processes
with a continuous process platform. We are pursuing future
innovations such as digital labs, factory of the future, and
advanced-analytics-based process understanding and control.
POSITION OVERVIEW /KEY RESPONSIBILITIES:
The successful candidate will work with a group of scientists and
engineers responsible for development & characterization of next
generation cell culture processes, technology transfer to a diverse
network of manufacturing facilities, and support of advanced
manufacturing investigations and process improvements for
commercial products. We are looking for a candidate with excellent
scientific, communication, and project management skills. This
individual will work in a fast-paced, team environment,
collaborating with colleagues across functions in the organization
to solve a wide range of complex problems in creative and practical
ways.
Specific Responsibilities include:
* Lead Upstream project teams encompassing study design, execution,
and data analysis, with the aim of improving process robustness and
developing next-generation processes for monoclonal antibodies and
recombinant proteins
* Prepare presentations and data sets to effectively communicate
results, progress, and plans within the department and as the
Upstream representative on LCM product teams and technology
transfer teams
* Contribute to or lead technical investigations of complex
deviations in manufacturing
* Work collaboratively with technical leads and SMEs in the
downstream, analytical, and pilot lab areas
* Serve as a technical leader in introducing and developing new
technologies, platforms, and capabilities in the Upstream
laboratory
* Lead or participate in the set-up and maintenance of Upstream
laboratory systems, practices, and training
* Responsible for internal documentation and preparation of reports
required for regulatory filings. May support authoring of
regulatory filings
* Mentor Upstream project team members in a matrix managed setting.
May supervise a small team of scientists and engineers
* Represent the Upstream team as an SME or technical lead in
cross-site, cross-functional teams with external partners and
CMOs
BASIC QUALIFICATIONS:
* Degree in life sciences, engineering, or other relevant
degree
* Minimum years of experience: BS with 9 years, or MS with 7 years,
or PhD with 5 years of experience
* Experience in biologics development, bioprocess engineering,
technology transfer, and / or commercial manufacturing
operations
PREFERRED QUALIFICATIONS:
* Excellent scientific background, technical writing, and
presentation skills
* Highly motivated individual with the ability to work
independently and on cross-functional and cross-site teams
* Hands-on experience with mammalian cell culture process
development at laboratory, pilot, or manufacturing scale
* Knowledge in bioreactor design and control strategies, scale up
and scale down approaches as applied to mammalian-expressed
proteins
* Self-motivated with excellent attention to detail and superb
organizational skills, having a proven ability to work in a highly
collaborative environment and communicate transversally
* Flexible with ability to adjust to a fast-paced, goal-oriented
environment and willingness to expand and broaden skillset
* Experience managing and developing scientific staff
* Demonstrated ability to become a cell culture SME in a relevant
field, e.g., medium development, omics, PAT, cell banking, process
intensification, scale up / down, or process automation or
miniaturization
* Knowledgeable in other cell culture systems and modalities, such
as insect cell culture or gene / cell therapy
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.
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 START
DATE.
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
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-SG
#LI-GZ
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.
Keywords: Sanofi, Framingham , Senior Scientist, Other , Framingham, Massachusetts
Click
here to apply!
|