Senior Scientist - 1402946
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 in Cryogenics will report directly to the Associate Director of Process Development. This newly formed group will initially be located in Hopkinton, MA; however, the location will transition during late 2015 to a new Biologics Center of Excellence under construction in nearby Devens, MA. The Cryogenics group will work closely with Downstream Process Development (PD), and Manufacturing. The purpose is to provide technical support designing and implementing cryogenics of biologics drug substance to deliver robust, scalable and economical processes for late stage clinical and commercial processes from mammalian cell culture operations for BMS pipeline biotherapeutics. There will be significant collaborations with colleagues in Manufacturing, Manufacturing Technology, and Manufacturing Sciences and Technology groups.
- Serve as a technical lead and subject matter expert in large/small scale bulk fill, freezing, and storage of drug substance
- Lead cryogenic operations, optimization, characterization, and tech transfer within PD
- Set up operations and initiate function of this new PD group
- Experimental design and study execution
- Expectation for hands-on operation in lab
- Represent PD on cryogenic operations on multiple project teams
- Support process scale up activities in pilot plant and clinical manufacturing sites
- Prepare/review/approve technical documents including development /tech transfer reports, batch records, SOPs and CMC regulatory submissions
- Drives new technology initiatives, establishes intra and interdepartmental collaborations and directs the necessary experiments for evaluation and implementation
- Mentor and develop team members
- PhD: Chemical/Biochemical Engineering, Biochemistry, Biophysics or equivalent with a minimum of 6+ years of industry and/or academic experience
- Bulk scale freeze/thaw and lyophilization experience
- Knowledge of analytical techniques relating to glycoprotein attributes
- Practical experience of cGMPs
- Statistical experimental design and data analysis experience
- Process development experience for both early and late stage molecules
- Experience in commercial manufacturing and biopharmaceutical regulatory submissions is preferred
- Excellent oral and written communication skills
- Prior management experience leading people and within multi-disciplinary teams
- Ability to work collaboratively in a team environment