Global Head Synthetics CMC Development
Company: Sanofi
Location: Cambridge
Posted on: August 5, 2022
Job Description:
POSITION OVERVIEW:The fully integrated Global CMC Development
function at Sanofi covers multiple modalities including biologics
and small molecules; synthetic molecules, mammalian and microbially
expressed proteins, as well as cell/gene therapy. Global CMC
Development is a key enabler in Sanofi R&D s ambition. Their
mission is to develop manufacturing processes, formulations, and
analytical methods; scale up and manufacture clinical trial
material; and lead/manage CMC teams clinical supply/demand
management, and authoring/coordinating regulatory submissions.The
Global Head of Synthetics CMC Development is a high impact and high
visibility role that sits within CMC Development and reports to the
Global Head of CMC Development. The individual will be responsible
for all aspects of CMC activities for synthetic molecules,
including chemistry route definition, API process development,
formulation and DP development, analytical development, and
testing, scale-up/technology transfer, clinical trial material
production, and regulatory document authoring, from early research
engagement with the medicinal chemistry group all the way through
clinical development leading up to NDA submission and approval.With
several exciting late-stage synthetic molecules and a steady stream
of molecules from Sanofi research and in-licensing activities, this
is an exciting time to lead this organization through successful
development and approvals.KEY ACCOUNTABILITIES:The Global Head of
Synthetics CMC Development will develop and execute strategies to
efficiently progress the synthetics pipeline, and will be a member
Global CMC Leadership Team. They will be responsible for a global
organization (greater than 400 employees) with operations in
France, US, and Germany, and hence may be in any of these
locations.The individual will deliver Sanofi s synthetic molecule
portfolio in close coordination with other Sanofi functions
spanning from Research through commercialization. The scope of the
role includes, Early Development (working closely with medicinal
chemistry), Synthetic Chemistry, Process Chemistry using
traditional and advanced technologies), such as continuous flow and
bio-catalysis), Formulation and Final Dosage Development:
Analytical Chemistry, Clinical manufacturing, and QC testing.KEY
REQUIREMENTS:Serve our patients and deliver on Sanofi and R&D
aspirations through the following Behavioral Competencies
- Strategic: Define and execute functional strategy based on
internal / external landscape
- Result-Oriented: Demonstrate ownership in delivering results
and creating value by ensuring team engagement, prioritized
resource allocation, and delegation
- People Leadership: Set aggressive goals and deliver by building
an inclusive team with a feedback culture
- Relationship and Influence: Engage with internal / external
stakeholders by creating an inclusive environment based on trust
and astute understandingBASIC QUALIFICATIONS:
- PhD in Chemistry/Chemical Engineering or a related field.
- At least 20 years relevant global industrial experience in a
dynamic environment
- Demonstrated experience of bringing multiple synthetic
pharmaceutical products to global markets.
- Experience managing one or more of the technical functions,
i.e., Synthetic/Process Chemistry, Formulation, and Analytical
Chemistry
- Highly knowledgeable in all aspects of drug development with
special emphasis on all aspects of CMC and a demonstrated history
of innovation in the field of synthetics CMC
- Growing list of peer-reviewed publications in the synthetic CMC
field, including patents and conference presentations;
- Highly knowledgeable in quality requirements and regulations as
well as recent trends that govern synthetic molecule CMC
development and NDA submissionsPREFERRED QUALIFICATIONS:
- Experience of at least five years managing a team of 100 or
more scientists/engineers. 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 all.
Keywords: Sanofi, Cambridge , Global Head Synthetics CMC Development, Other , Cambridge, Massachusetts
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