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
The Associate Scientist will be responsible for
supporting development of analytical separation-based methods within the
Biologics Methods Development Group part of Analytical Development and Testing
(ADT). Method Development group is focused on development of robust
chromatographic and electrophoretic methods for protein-based therapeutics for
late phase commercial process development. The role will involve method
development, evaluation, optimization and design of Experiments so as to
establish robust techniques to support future commercial molecules. The
successful candidate will work closely with Process Development and Quality
Testing groups within BMS network and external contract laboratories. The role
will have active interaction with Analytical Science and Technology (AS&T),
Process Analytics and network method development teams. The successful
candidate is expected to take active role in the planning and execution of
basic analytical method development, validation and verification experiments,
and deliver quality analytical data for method development reports in a timely
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 Method Development group. 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. The ideal candidate will execute
assay development activities within Analytical Development network
- Plan and execute Analytical Development activities
- Develop, evaluate and qualify analytical methods for
monoclonal antibodies and recombinant proteins to support late phase drug
- 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.
- MS with 3+ years or BS with 5+ Years of relevant work
experience in Bio-pharmaceutical or Pharmaceutical industry.
- Experience in Analytical techniques including HPLC/UPLC
with multiple modes of separation (RP, IEX, SEC and HIC) and multiple detection
modalities (UV, FL, MS, MALLS, CAD) as well as working knowledge of LC/MS.
- Familiarity with software packages including Empower,
MassLynx, Analyst and X-Caliber is highly desirable.
At least 3 year(s)
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