BD, a leading global medical technology company that makes and sells medical devices, instrumented systems and reagents, is dedicated to improving people’s health throughout the world. BD is focused on improving drug therapy, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. The Company’s capabilities are instrumental in combating many of the world’s most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs more than 29,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. BD is an Equal Opportunity/Affirmative Action Employer.
The R&D scientist will focus on analytical subcontractor management (R&D studies, validations, analytical transfers). He/She will also provide on site analytical technical support to the laboratory and be facilitator in R&D/QC discussions.
He/She will participate to technical teams to facilitate analytical transfers from R&D to
or subcontractor lab and help with troubleshooting. He/ She will contribute to the regulatory strategy and submission filing and perform other duties to include but are not limited to:
Technical assistance for all analytical validation activites
Technical assistance for all analytical transfer activities
Protocol / report review
Build analytical documentation (test procedures, protocols and reports) with the subcontractor
Give prompt feedback on all questions they have
Build quotations / Track financial items with product leaders in France (alerts, reminders, etc.)
Required skills and Knowledge —
MS degree in Chemistry / Analytical Chemistry with a minimum experience of 3 years in pharmaceutical industry or Bachelor’s degree chemistry or analytical chemistry with a minimum of 5 years of relevant Analytical Chemistry experience in a pharmaceutical manufacturing company.
Experience and knowledge of UPLC, HPLC, GC, UV, and other analytical equipment. Experienced in analytical validation and analytical methods transfers.
Excellent attention to detail and working knowledge of FDA Regulations/Guidance’s, Good Laboratory Practices, Good Manufacturing Practices, and ICH Guidelines, USP/NF.
Maintains a safe working environment.
Proven ability to use initiative and drive to achieve results.
The incumbent must be able to effectivley interact with multi-cultural teams in a cGMP environment. Excellent verbal and written communication skills are required to include demonstrated proficientcy in French. Project managment skills are required for this role. The incumbent will be expected to regularly interact with regulatory agencies.
Degree of Accountability (discretion/supervision) —
Work is supervised but requires an associate who can work independently, reporting directly to the R&D Analytical Development Supervisor based in Pont de Claix site,
, with local support of the
Validation-Product Scale-up Manager
First Shift / Day Job
Becton Dickinson - 22 months ago
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