Scientist Bioprocess Analytics

This position resides within the BioProcess Analytics group which is part of the Global CMC Development organization at Sanofi, Framingham, MA.  The candidate will be a part of a multi-disciplinary team providing analytical support to a strong pipeline of R&D programs within Sanofi during early and late-stage process development.

We are looking for a skilled, highly motivated individual with expertise in analytical chemistry who works well in a team-setting to meet project and development goals within the established timelines. The successful candidate should have in-depth knowledge and hands-on experience of protein and/or mAbs separation and post-translational modification (PTM) characterization using liquid chromatography and capillary electrophoresis (CE) techniques. This role will be involved in performing laboratory activities as an individual contributor and mentoring and training junior analysts within the team to support process development and advance existing analytical testing platforms.

Key Responsibilities:

• Strong track record of independent and in-depth knowledge of proteins and/or mAbs separations such as HPLC/UPLC, CE and cIEF. Analytical method support, optimization, qualification, and troubleshooting as required to support programs in early and late-stage research through the various development stages.

• Evaluate and develop new cutting-edge technologies, instruments, and analytical methods in separation science to streamline and improve the efficiency of assay workflows and to solve problems encountered during drug development.

• Assess multiple quality attributes of therapeutic proteins with emphasis on post-translation modifications (e.g. glycosylation and deamidation), using HPLC/UPLC, CE and cIEF

• Develop and apply novel sample preparation and analytical methods for the analyses of intact proteins and the released glycan profiling.

• Provide subject matter expert (SME) technical support for the mentioned assay formats in a non-GMP setting.

• support of other analytical methodologies such ELISAs and other binding assays, impurity assays such as detection of host cell proteins, residual impurities, and LC-MS/MS peptide-mapping based on project needs.

• Mentoring junior analysts to ensure timely completion of testing / development assignments, providing guidance and mentorship to help junior staff nurture their career growth.

• Maintain good communication and collaboration with other organizations within the Sanofi network and external partners.

• Author technical reports, study protocols and manuscripts for publication; present at internal and external meetings and conferences.

Basic qualifications:

• Ph.D. in Analytical Chemistry, Biochemistry, or related discipline with 0-2 years of relevant experience or Master degree with a minimum of 4 years of relevant working experience in the biotechnology/pharmaceutical industry.

• Strong knowledge of protein/mAb analysis and hands-on experience for protein/mAb and glycan separation techniques with excellent instrumental operation and method troubleshooting skills with different vendors.

• Experience in evaluating/developing new technologies in an independent manner with the ability to propose/design implementation strategies if deemed appropriate.

• The successful candidate is expected to be an independent, self-driven team player who not only contributes to assigned activities but helps to advance the capacity and efficiency of BioProcess Analytics.

• Strong problem-solving, communication and interpersonal skills.

Preferred Qualifications:

• PhD in Analytical Chemistry, Biochemistry with emphasis in protein separation science (e.g. HPLC, CE)

• 2+ year’s post-PhD experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development.

• Experience with Waters or Agilent HPLC/UHPLCs, PA800 Plus and Maurice/iCE

• Proficiency with the use of analytical software such as Empower, OpenLAB, Chromeleon, 32karat and compass with an understanding on optimizing/automating data analysis.

• Familiarity with automation instrumentation (Tecan, Hamilton liquid handlers).

• Basic understanding of GMP requirements specific to assay qualification/validation.

• Experience in qualification of analytical methods following ICH guidelines

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.

#GD-SA
#LI-SA
PDN

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.