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Senior Scientist/Principal Scientist, Oligonucleotides

Framingham, Massachusetts, Frankfurt am Main, Germany

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Responsibilities

POSITION OVERVIEW:

Senior/Principal Scientist will be part of the oligonucleotides subject matter expert team and is responsible for providing technical and program management leadership by performing the following duties:

  • Leads LCM programs by representing MSAT in global Industrial Affairs (IA) cross-function and cross-site product teams. 

  • Provides vital technical insight to global MSAT programs including process and analytical development, process control strategy, continuous process verification, manufacturing support and improvement, global tech transfer and validation. Leads LCM activities in MSAT project teams.

  • Provides scientific guidance to MSAT Lab operations regarding the design, set-up, and execution of scale-down experiments. Participates in Lab results analysis and bridging between the experimental outputs and manufacturing practice

  • Participates in monitoring the health of manufacturing process capability across the product portfolio manufactured in internal/partner Industrial network to identify common trends or major risks in their expert domain and recommends preventative or remedial actions to Manufacturing, Molecular Stewards or Site teams as appropriate for implementation

  • Works with cross-functional teams to resolve deviations, align global control strategies (raw materials, process, methods, equipment), and mitigate potential risks.

  • Support QC and regulatory teams during health authority audits and prepare for supportive  regulatory documents for responses or new filings. May lead internal documentation and preparation of reports required for regulatory documents

  • Provides technical mentorship and training to Lab operation team and manufacturing team as needed

BASIC QUALIFICATIONS:

  • Degree in chemistry, chemical engineering or other relevant discipline

AND

  • BS with 10+ years of professional experience

OR

  • MS with 7+ years of professional experience

OR

  • PhD with 5+ years of professional experience

AND

  • Minimum of 4 years of hands-on experience in oligonucleotide synthesis and/or commercial manufacturing operations

PREFERRED QUALIFICATIONS:

  • Process development experience with synthesis of oligonucleotides and small molecules
  • Knowledge across technical domain (synthesis, process HPLC, formulation, lyophilization)
  • Prior experience with leading projects and mentoring technical staff
  • Excellent verbal and written communication skills
  • Highly motivated individual with the ability to work independently as well as on a cross-functional and cross-site teams

SPECIAL WORKING CONDITIONS: 

Domestic and International travel required

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.

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