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Senior Scientist, New Brunswick, New Jersey

Created10/08/2020
ReferenceR1530405
CategoryQlty Assurance Methods
Job typeFull-Time
CountryUnited States
StateNew Jersey
CityNew Brunswick
Zip08901
SalaryCompetitive

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The position will manage all aspects related to the commercial analytical method lifecycle for advancement of the pharmaceutical portfolio of products. This involves responsibility to develop and align analytical validation and technology transfer activities with project teams, analytical development, Quality and other key stake holders to ensure compliance with current regulatory standards. Key responsibilities are to enable the implementation of test methods in a QC environment for analysis of the physical and chemical properties of pharmaceutical materials (drug product, drug substance, raw materials etc.). The incumbent will provide their subject matter expertise to serve as a key partner in ensuring robustness of the methods, troubleshooting and triaging the methods throughout the product lifecycle.

Responsibities:
  • Prepare/review/approve protocols and reports for analytical methods, their validation and technology transfer.
  • Participate in cross-functional teams as the analytical subject matter expert representing the interests of Technical Operations, e.g.,manufacturing launch teams, technology transfer teams, etc.
  • Manage and supervise the technical transfer of analytical methods to third party contract manufacturers. Review and approve data for accuracy and agreement with acceptance criteria. Effectively manage and coordinate the analytical testing at TPM; investigate and resolve data discrepancies.
  • As necessary, assist BMS QC sites and TPMs with OOS investigation and troubleshooting.
  • Resolve questions/ troubleshoot analytical techniques, procedures and validation requirements from BMS sites and third parties.
  • Review method validation documentation to determine compliance with ICH requirements and manage remediation of gap analysis at TPM or in BMS laboratories.
  • Prepare /review and serve as subject matter expert for departmental SOP's.
  • Support Global Testing Standards group by reviewing change control documents, compendial monographs and proposed methods and specifications.
  • Perform laboratory work to support product or process troubleshooting, special investigations and product complaints with limited supervision.
  • Assist in the general operation of the analytical laboratory, including maintenance of Standard Operating Procedures (SOP's), training and equipment validation or maintenance.
  • Support the market life stability program by providing analytical expertise to perform analytical method troubleshooting and assist with OOS laboratory investigations at the Stability testing laboratory.
  • Partner with External Manufacturing department to support all matters related to analytical method support at TPMs, including technology transfer, method troubleshooting and OOS laboratory investigations.


Qualifications
  • BS/MS/PhD in the chemical, pharmaceutical or life sciences required
  • Minimum of 6+ years related experience in an analytical chemistry position
  • Must have demonstrated thorough working knowledge of chemical analysis, including HPLC, GC, Dissolution.


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
EmployerBristol-Myers Squibb

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