Scientist – Method Development (1403446)
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 ideal candidate will execute assay development activities within Analytical development and Testing network laboratories. The ideal candidate will develop fit for purpose analytics for Novel Biologics candidates for LC and CE based analytical platforms. The candidate will be involved in a continuous improvement of all analytical development activities. The candidate will help establish data trending and assay maintenance programs. The successful candidate will have excellent 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 role will provide Analytical Development support multiple mid and late phase molecules within Analytical Development and Testing organization. The candidate will work closely with PDA team members.
- Plan and execute analytical development activities for DS and DP
- Develop, evaluate, qualify and transfer Bio-analytical techniques for monoclonal antibodies and recombinant Proteins to support late phase drug development activities
- Write SOPs, transfer reports, assay evaluation/development and qualification reports
- Contributes selected 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
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.
- PhD in Analytical biochemistry, Analytical Chemistry, Biotechnology, Protein Chemistry, Automation and Analytics
- 3 to 5 years experience in Analytical Development or Process Analytics environment
- Experience in HPLC/UPLC with multiple modes of separation (RP, IX, SEC, HIC) and detection including UV, FL, MS, MALLS, RI and CAD
- Experience in Capillary Electrophoresis (PA800plus, iCE-IEF, Caliper and traditional gel techniques)
- Experience with 1D and 2D western blot and immunoassays is highly desirable
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