Title: SENIOR SCIENTIST
Location: NA-US-MA-Hopkinton
Job Number: 1405536
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.
Bristol-Myers Squibb has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts. The expansion will create 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 Senior Scientist will be involved in the management, training, planning and execution of Analytical Development activities within Analytical Development and Testing department which is part of the Biologics Development Organization. The ideal candidate will execute assay development activities within the network ADT laboratory groups, and will evaluate new and platform analytical techniques, which includes development and qualification of multiple LC and CE based assays. The role will present with opportunities to lead technical agenda and gap analysis of mid/late phase Biologics, Critical Quality Attributes and analytical gap analysis. The ideal candidate will develop fit for purpose analytics for Novel Biologics candidates. The candidate will be involved in a continuous improvement of analytical development methods and processes. The successful candidate will have excellent verbal and written communication skills, is a team player, and have in-depth and broad experience in Bioanalytical techniques as they apply to Biologics Product Quality and related process impurities. The ideal candidate will have extensive GMP/GxP experience in analytical development and/or Quality Control setting. This newly formed role will initially be located in Hopkinton, MA, which will transition to the New Biologics development site in Devens, MA towards the end of 2015.
Responsibilities:
Lead a group of Scientists and Associate Scientists • Plan and execute analytical development activities
Develop, and co-qualify Bio-analytical techniques for monoclonal antibodies and recombinant Proteins to support late phase drug development activities
Drive Biologics technical agenda – Identify and resolve analytical technical gaps of multiple Biologics portfolio
To work closely with Analytical method development team and Process Development
Engage with cross functional teams to set up a strategy for process control and CQA development.
Write SOPs, transfer reports, assay evaluation/development and qualification reports
Contributes analytical section in IND and BLA filings
Assist in the establishment of Analytical Development labs in Hopkinton and Devens
Represent Analytical Development within Process Development project team and inter-functional teams
Supports, reviews and supervises CROs and CMOs working on multiple projects
Established expert in a niche Analytical area
Actively engaged in industrial hot topics discussions Qualifications: The successful candidate will have:
PhD in Analytical biochemistry, Analytical Chemistry, Biotechnology, Protein Chemistry, Automation and Analytics with 8 years experience in Analytical Development and Process Analytics environment OR at least 12 years of experience for candidates with Masters Degree only.
Experience in electrophoresis (Capillary and traditional gel technique)
Experience with HPLCs with multiple modes of detection including UV, FL, MS, MALLS and RI,
Experience in immunoassays (ELISA, 1D and 2D western blots)
Automation experience in either Process or analytical setting is highly desirable.
Understanding and background in Particulate analysis using various traditional and novel techniques such as Nanosight and MFI is a plus.
Biophysical techniques – FTIR, Raman, DSC, DLS and MALLS are desirable
Working knowledge of design of Experiments and Factorial Design Job: Process Development