Senior Scientist - Method Validation and Transfer

POSITION SUMMARY: At Bristol-Myers Squibb, we believe that together we can make the difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients. Our large-scale biologics manufacturing facility in Devens, Massachusetts has  an exciting career opportunity to join Bristol-Myers Squibb, one of the world's leading BioPharma companies.  We've created one of the world's premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless. It is a site that combines biologics development with clinical and commercial manufacturing on a single campus - a true biologics center of excellence for the company where teams are encouraged to closely collaborate. The Analytical Sciences & Technology group is committed to supporting our global biologics analytical network withreliability, integrity, active engagement, and cross functional collaboration. The Method Lifecycle Group in the Analytical Sciences and Technology department provides analytical oversight for the transition of programs entering the commercial space following clinical development.  The Method Lifecycle Group is looking for a Senior Scientist with proven experience in driving and managing method validation and technology transfer of analytical methods. The successful candidate will take a leading role in defining new scientific approaches, data analysis, facilitate method transfers and method qualifications and validations. Critical thinking, trouble-shooting and attention to detail is a must. This is a non-GMP, part laboratory based and part office based role. Candidate will be required to plan experiments, guide other team members, as well as to analyze data generated at numerous sites for method validations and transfers. Ability to work collaboratively and across different functions in fast-paced environment is required. Hands on qualification/ validation experience in compliance withregulatory requirements is required and working in a late stage/commercial environment is preferred.  Successful candidate must be able to manage and coordinate multiple tasks and timelines. Duties/Responsibilities: Provide technical leadership of method validation. This includes partnering with analytical development to ensure method readiness for validation, writing validation protocols, gathering data generated by analytical development/QC labs and writing validation reports.  Provide technical oversight of method revision following validation. Lead method transfers to QC GMP labs within and outside of BMS. Guide less senior members of the group through validation and method transfers. Actively lead and work on internal initiatives for improvement of business processes. Assist in obtaining critical reagent supply and samples required for validation and transfer purposes. Assist in the periodic review of method performance and work with team leader to design and execute remediation experiments and implement changes to existing commercial methods. Review validation and transfer summaries in regulatory filings. Respond to Health Authority queries regarding method validation and transfer. Work collaboratively across organization and sites for method readiness, transfer, performance and trouble shooting in commercial environment. Work closely with all AS&T team members to understand their deliverables to achieve organization goals. QUALIFICATIONS Specific Knowledge, Skills, Abilities, etc: Demonstrated experience with the validation of bioassay, immunoassay (impurities), and separation methods, including ELISA, Electrophoresis, Chromatography, qPCR, and UVIS spectroscopy based technologies. Extensive familiarity with USP/ICH guidelines.  Familiarity with international guidelines (EP, JP etc.) is highly desired Demonstrated experience of method transfer. Experience of working with colleagues at remote sites. Knowledge of GMP principles is required. Ability to work independently. Strong written and communication skills and experience working in a matrix organization. Education/Experience/ Licenses/Certifications: Bio-therapeutic development & industry experience required: BS with 10+ years, MS with 6+ years or Ph.D. with 4+ years. Physical Demands: This role requires office work, biochemical laboratory work, computer work, group meetings, and thus involves the following: sitting, standing, walking, working with analytical instruments, repetitive motion including bending and lifting small containers/equipment's. Work Environment: Working in an analytical laboratory handling chemical reagents that may be hazardous (corrosive, toxic, flammable etc.). Office work, teleconferencing, computer work, leading meetings requiring working in open office environment, working alone and working with/around others. Travel This position may require occasional domestic and international travel. R1510815
Salary Range: NA
Minimum Qualification
11 - 15 years

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