Bristol-Myers Squibb Company

RSCR Biologics Scientist

Location
New Brunswick, NJ, United States
Posted
May 23, 2019
Ref
R1514934
Required Education
Bachelors Degree
Position Type
Full time
This position will directly support biologics operational activities for the Reference Standard and Critical Reagent (RSCR) Group within the Global Quality Analytical Science & Technology (GQAST) organization. Primary role will be to support all aspects of inventory maintenance for reference standards and critical reagent within the RSCR Operations group including (but not limited to) qualification and requalification of materials, documentation, maintenance of global standards inventory, and coordination of shipments to stakeholders as well as performing lab-based work as needed.

Responsibilities will include, but are not limited to:
  • Lead BMS biologics development program for Clinical Reference Standards and Critical Reagents, including inventory, documentation, data evaluation and qualification of materials and reagents. Coordinate qualification and requalification testing ensuring program timelines are achieved.
  • Support reference standard life cycle management by retrieving/mining reference standard data and collaborating with scientists/laboratory managers to analyze and effectively report trending data for method and reference standard performance for numerous biologic products and methodologies.
  • Work with Subject Matter Experts (SMEs), and testing laboratories to coordinate aliquotting and testing activities related to qualification/re-qualification of reference standards and critical reagents.
  • Author/review technical documents, protocols, qualification/requalification reports, and SOPs.
  • Administration of tracking activities and documentation for receipt, shipping and inventory management of reference standards and critical reagents.
  • Support the shipment and distribution of reference standards and critical reagents.
  • Adhere to GMP/GLP, and good documentation practices when documenting activities in equipment log books, worksheets and electronic inventory management systems according to department procedures reflecting the receipt, movement, handling and aliquoting to ensure accurate inventory control and traceability of reference standards and critical reagents.
  • Retrieve, review and provide information in support of regulatory filings as appropriate.


  • Minimum Qualifications:
  • B.S. or equivalent with a minimum of 6-8 years (or a M.S. with 4-6 years) of relevant experience in biologics development/pharmaceutical industry or equivalent.
  • Minimum of two years of analytical laboratory experience in a GMP environment is preferred and experience with biologics is a plus.
  • Experience in performing statistical analysis, interpreting statistical data, and using statistical software (e.g. JMP, SpotFire) is desired.
  • The ideal candidate will be able to pay strong attention to detail and can work independently.
  • Strong written and oral communication skills is essential and a background in project management skills is a plus.
  • Skill in communicating/escalating critical issues to appropriate management is necessary.
  • Understanding of cGMP/GLP and GDPs practices particularly in documentation of activities in logbooks and worksheets and EHS requirements is essential.
  • Ability to comply with all applicable SOPs, and departmental requirements is a must.
  • Expertise in MS Office applications, in particular Outlook, MS Word and Excel, is required.
  • Familiarity with electronic documentation systems (e.g. Syncade-DCA) for routing protocols/reports for review and approval is a plus.
  • Experience in the use of Labware LIMS, Sample Manager LIMS, Rees environmental monitoring system, automated/robotic liquid handling systems (e.g. Tecan), and Freezerworks inventory management system is a plus.