This position resides within the Analytical Development group,
part of the Global Biologics CMC Development organization at
Sanofi, Framingham, MA. The Analytical Development group has the
overall responsibility to develop, qualify and validate robust
analytical methods to support release and characterization testing
of protein candidates in early stage development (Phase I/II). The
Analytical Development group also performs cGMP sample testing for
the purpose of drug substance and drug product lot release and
We are looking for a skilled, highly motivated individual with
expertise in physicochemical method development who works well in a
team-setting to meet project goals within the established
timelines. In addition to mentoring and training junior analysts, a
significant part of this role consists of performing hands-on
laboratory activities as an individual contributor. The ideal
candidate is expected to have a solid background in separation
science, especially in capillary electrophoresis (CE-SDS, cIEF) and
HPLC, with extensive experience in protein characterization.
* Develop, qualify, and validate cGMP analytical methods for the
characterization, release and stability testing.
* Focus on various separation science platforms such as
electrophoresis (CE-SDS, CIEF) and HPLC (SEC, IEX, RP) using a
variety of detection modes. In addition, the individual may support
other physicochemical analytical methodologies and compendial
testing depending on project needs.
* Write and review method procedures, assay qualification and
validation plans/reports and ensuring that the documents adhere to
GxP requirements and ICH guidelines.
* Mentor junior analysts to ensure timely completion of
assignments with full data integrity. Providing guidance and
mentorship to help junior staff nurture their career growth.
* Maintain a GMP compliant laboratory environment. Serving as a
technical resource to solve analytical method and instrument
* Interface with CMC program management team and 3rd party
Qualifications and Skills:
* Ph.D. in Biochemistry, Analytical Chemistry or related
discipline or a Master's degree with a minimum of 4 years of
relevant industry experience or a Bachelor's degree with a minimum
of 6 years of relevant industry experience.
* Expertise in analytical protein separation techniques (CE and
HPLC) is required. Familiar with a variety of bioanalytical assays
such as cell based assays, binding assays, and mass
spectrometry-based assays is a plus.
* A fundamental knowledge of cGMP compliance requirements and
excellent organizational skills. Proven ability to adhere to good
documentation standards and maintain detailed records of all work
* Proven capability of evaluating/developing new technologies in
an independent manner and be able to propose/design implementation
strategies if deemed appropriate (e.g. method comparability
* A strong ability to work both independently or in
cross-functional teams and an ability to meet timelines efficiently
* Proven ability to work with a high level of integrity,
accuracy, and attention to detail.
* Hand on experience in multiple analytical technologies for the
characterization of biologics such as mAbs or fusion proteins.
* Direct experience with assay method development, qualification
and validation is a plus.
* Experience with and/or knowledge of the regulatory
requirements for early stage biologics development including
knowledge of appropriate control and testing strategies.
* Working experience in a GMP environment and ability to adhere
to all appropriate GMP standards (e.g. invalid result
investigations, deviations, and CAPAs) will be considered an
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