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 expanded of its large-scale biologics manufacturing facility in Devens, Massachusetts. The expansion 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 ideal candidate will execute assay development activities and testing within Analytical Development and network laboratories. The ideal candidate will develop fit for purpose analytical methods for Novel Biologic candidates using LC based analytical platforms. LC/MS and spectroscopic characterization to determine the identity of each peak is an integral part of method development. 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 must have excellent communication skills and must be a team player, who has in-depth and broad experience in analytical techniques that are applicable to assess Product Quality. This role will be located in the state of the art Biologics Development Building in Devens, MA. The role will provide Analytical Development support for multiple mid and late phase molecules within Analytical Development. Biological expansion at Devens 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 candidate will work closely with Process Development and Process Development Analytical team members. Responsibilities
- Plan and execute Analytical Development activities.
- Develop, evaluate and qualify analytical methods for monoclonal antibodies and recombinant proteins to support late phase drug development activities.
- Write SOPs, transfer reports, assay evaluation/development and qualification reports.
- Assist in the establishment of Analytical Development labs in Devens.
- Represent Analytical Development within Process Development project team and multi-functional teams.
- Requires a PhD or MS in Chemistry, Biochemistry or related field with 2 /5 years of experience in Analytical Method Development.
- A strong background in the areas of analytical chemistry/biochemistry, with strong emphasis on in-depth working knowledge of Analytical techniques including HPLC/UPLC with multiple modes of separation (RP, IEX, SEC and HIC) and detection including UV, FL, MS, MALLS, RI and CAD) and LC/MS are required.
- Working knowledge of instrument software packages including Empower, MassLynx, Analyst and X-Caliber is highly desirable.
- Biophysical Characterization of Biologics using DSC, CD, FTIR, AUC and MS is desirable.
- Demonstrated problem solving ability, interpersonal, and oral and written communication skills are essential.
- Considerable experience in Therapeutic Area of Biologics would be an advantage.
- It is essential to work independently and as part of the matrix organization.
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