Scientist, Analytical Development, Mammalian
Company: Principia Biopharma Inc.
Posted on: June 7, 2021
This position resides within the Analytical Development group,
part of the Global 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 stability
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.
Analytical method development, qualification, validation and
troubleshooting as required.
Focus on various separation science platforms such as HPLC/UPLC
(Size exclusion chromatography, Ion exchange chromatography,
reversed phase HPLC, and Hydrophilic Interaction Chromatography
(HILIC) using a variety of detection modes including mass
spectrometry. In addition, the individual may support other
analytical methodologies such as capillary electrophoresis, binding
assays depending on project needs.
Write and review method protocols, 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.
Maintain a GMP compliant laboratory environment.
- Interface with third party contract laboratories.
Ph.D. in Biochemistry, Analytical Chemistry or a 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.
Proven experience with the analysis, identification, and
characterization of complex glycan structures associated with
biologics. Technically skilled in HPLC analysis (IEX, SEC and
Reversed-phase), mass spectrometry, CE.
Strong background in UPLC/HPLC, including familiarity with
instrumentation from different vendors, excellent instrument and
method troubleshooting skills, as well as knowledge of various data
analysis approaches are required.
Proficiency with the use of chromatography data systems such as
Chemstation, OpenLab, and/or Empower.
Proven ability to adhere to good documentation standards and
maintain detailed records of all work performed.
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
Previous experience with maintaining laboratory equipment
including HPLC/UPLC, QDa, QToF and QQQ systems.
- The successful candidate is expected to be an independent,
self-driven team player who is ready to provide guidance and
mentorship to junior staff as a direct supervisor or in a matrix
Experience in glycan/glycan identification and analysis using
mass spectrometers and HPLC/UPLC would be beneficial for the
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
Keywords: Principia Biopharma Inc., Framingham , Scientist, Analytical Development, Mammalian, Other , Framingham, Massachusetts
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