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Deputy Director Principal Scientist QC-Swiftwater,PA

QC Principal Scientist

Site QUALITY

Industrial Operations, Swiftwater, Pennsylvania, USA

Who We Are

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients? needs. Sanofi Pasteur, the vaccines division of Sanofi, is a global company that provides more than one billion doses of vaccine each year against 20 infectious diseases, making it possible to immunize more than 500 million people across the globe. Industrial Operations (IO) site at Swiftwater, Pennsylvania, one of the largest vaccine manufacturing sites in the USA, continues to develop its manufacturing assets for existing and new vaccines and bio-pharmaceuticals.

The Position

The Principal Scientist of Quality Control will responsible for being the technical subject matter expert in all assays of the QC Bioassay platform and associated Immunological techniques.? These include but are not limited to Single Radial Immunodiffusion, Ouchterlony, Hemagglutinin Inhibition and ELISA based assays.? Major responsibilities include providing scientific and technical guidance on test issues and data interpretations while ensuring a high-level of cGMP compliance.? The Principal Scientist is also responsible for providing technical support for US and international Fluzone? production and various Fluzone? projects teams.? The successful candidate will have excellent?communication skills and writing proficiency along with good analytical, organizational and computer skills.? In addition, a good?understanding of vaccines/biologics products and associated technologies, sterility assurance and associated techniques.

Key Accountabilities

Project Support:? Participate and contribute to analytical working groups as required to support project milestones and provide strategic review and direction, including detailed plans and risk assessments as required.? Maintain GxP compliance, where required, in all testing programs.? Author, review and approve test method technical reports.?

Laboratory Support: Assists in the write up and completion of laboratory investigations with potential product, process, or material impact.? Actively participates and supports all regulatory inspections of the site.? Continuously improves and implements new technologies for performance and compliance.? Represent Quality Control on various Fluzone? production teams, process improvement and market expansion projects.????

Test Method Validation:? Validate and qualify analytical test methods in support of release and stability testing for US and International Fluzone with focus on SRID international requirements.? Design and lead the validation strategy and author or review and approve validation protocols.??

Test Method Transfer:? Assist in the transfer of analytical test methods in support of release and stability testing into receiving departments.? Design and approve transfer protocols.? Ensure the training of analysts who receive the assay. Author, review and approve method transfers from external and internal labs to design method transfer plans and final reports.

Regulatory Expertise:?? Subject matter expert in regulatory requirements related to departmental assays.

BASIC QUALIFICATIONS:

  • Master?s degree required in a Science or Regulatory discipline with a minimum of 5 years of in vaccine/biotech industry.?
  • Extensive knowledge of?cGMPs, ICH guidelines EMA guidelines and international regulatory requirements
  • Expertise in ?interacting with the FDA and other regulatory inspectors during cGMP inspections
  • Expertise in Antibody-based assays, SRID and demonstrated assay trouble-shooting ability.
  • Experience in maintaining laboratories and equipment in cGMP and/or GLP compliance.
  • Familiarity with Statistical Analysis.

PREFERRED QUALIFICATIONS:

  • PhD is preferred.
  • Familiarity with testing in compliance with current regulations is preferred.

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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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.



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