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Scientist - Analytical Development

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.   One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.   The expansion of the large-scale biologics manufacturing facility in Devens, Massachusetts has created a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site. Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.   The Scientist will be working within the Biologics Development (BD) organization. The role will involve the development, qualification and transfer of analytical separation methods used for product release, stability study and process characterizations supporting late phase programs. The successful candidate should be self-motivated, have excellent communication skills, be a team player, and have knowledge and experience in protein chemistry and bioanalytical techniques including chromatographic and electrophoretic separations. Desired skills include Design of Experiment (DoE), HPLC/UPLC, LC-MS, Capillary Electrophoresis, SDS-PAGE, as well as biophysical characterization and biological techniques. Knowledge and experience with protein / peptide characterization and molecular and cell biology would be a plus.   Responsibilities: Develop, qualify, transfer and characterize bio-analytical techniques for monoclonal antibodies, recombinant proteins and Advanced Therapy Medicinal Products (ATMPs) to support product release, stability and process characterization studies under targeted timelines. Author method SOPs, development and qualificationreports. Provide training and oversight of assay performance to testing labs including CROs. Work collaboratively across organization and sites for method readiness, transfer, performance and trouble shooting supporting late phase development projects. Authors and reviews analytical method and validation sections in IND filing documents Train and coach junior scientists Utilize statistical tools for Design of Experiment (DoE) to optimize assay conditions and evaluate assay robustness, and to analyze and trend development data. Actively lead and work on internal initiatives for improvement of business processes. Evaluate new technologies and lead scientific and technological innovations for process improvement. Work closely with commercial development teams supporting commercial method validation and BLA filings. Qualifications: The successful candidate will have A degree in Biochemistry, Biotechnology, Analytical Chemistry, Molecular Biology, Virology, Chemical / Biological / Biochemical Engineering or a related discipline. PhD with 2+ years or MS with 7+ years or BS with 10+ years relevant experience in Biotech or Pharmaceutical industry.   A strong background in the areas of analytical chemistry/biochemistry, with the emphasis on experience and in-depth working knowledge of CE, iCE, and HPLC/UPLC (UV/FL/CAD/MS). Experience with protein fragmentation (CE-SDS, RPLC), charge variants (AEX/CEX/CIEF/iCIEF), N-glycans, peptide mapping and aggregation/HMW analysis (Size Exclusion Chromatography) techniques is highly desirable. Experience with mass spectrometry and biophysical characterization is a plus. Experience with PCR, ELISA, Western Blotting, Cell based bioassay is a plus. Working knowledge of design of experiments and basic statistical knowledge is desirable. Familiarity with biologics process and regulatory requirement for biologics development. Knowledge of cGMPs as applied to analytical development and testing. Development experience for both early- and late-stage programs is highly desirable. Excellent communication and interpersonal skills. Works independently and collaborates with other groups. Deliver results in line with project and team objectives. R1512205
Salary Range: NA
Minimum Qualification
11 - 15 years

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