Sanofi Group Analytical Development Scientist in Framingham, Massachusetts
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 testing.
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 approaches).
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 setting.
Experience in glycan/peptide identification and analysis using mass spectrometers, CE and HPLC/UPLC would be beneficial for the position.
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 advantage.
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 all.