Molecular Biology QC Scientist - Vaccine

Location: Meriden, CT

MAJOR RESPONSIBILITIES:

Be the subject matter expert in molecular based assays for quality control testing for drug product, drug substance, and working virus banks in an efficient, cGMP compliant and safe manner. Major responsibilities include maintaining a high level of regulatory compliance and providing technical and compliance guidance on testing processes and results. Address technical/Analytical/Compliance issues related to QC testing and support Analytical development, Validation, and transfers. Assist and help drive the technical aspect of deviations, CAPA's, change controls and drive continuous improvement efforts including lab efficiencies and operational excellence endeavors. Support laboratory management during regulatory audits and serve as subject matter expert for identified QC assays.

KEY ACCOUNTABILITIES:

• Exhibit proficiency in troubleshooting issues with sample discrepancies, instrumentation, equipment, and methods. Provide testing/technical guidance on Potency Immunodiffusion, PCR, Southern blots, Primer design, DNA Extraction, Gel Electrophoresis and Sequencing analysis.
  
• Participate in Writing, updating, reviewing, and peer proofing activities within and between departments as required.
  
• Serve as the Subject Matter Expert on assays under the purview of the role.
  
• Support test method transfer between PSC departments, Sanofi Pasture sites or external testing labs.
  

BASIC QUALIFICATIONS:

Minimum Bachelor's degree in Biology or in a Scientific discipline plus

Minimum 5 years' of industry experience in a regulated cGMP Laboratory setting and

Proficiency in Molecular Biology assays

Method validation/Transfer experience

Expertise in PCR methods, Sequencing, Gel electrophoresis, etc.

OR

A Masters of Science degree or higher degree in Biology or in a Scientific discipline plus

Minimum 3 years' industry experience in a regulated cGMP Laboratory setting and

Proficiency in Molecular Biology assays

Method validation/Transfer experience

Expertise in PCR methods, Sequencing, Gel electrophoresis, etc.

PREFERRED QUALIFICATIONS:

• An understanding of routine QC operations, including testing and documentation practices.
  
• Technical writing capability.
  
• Basic statistical concepts and use in data analysis
  
• Proficiency in using Microsoft Office
  
• Proven logic and decision-making abilities and critical thinking skills.
  
• Knowledge of troubleshooting and problem-solving skills
  
• Proven leadership, verbal and written communication, organizational, critical thinking, and action oriented.
  

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.

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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