- Devens, MA
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
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.
The expansion of the large-scale biologics manufacturing facility in Devens, Massachusetts 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 Senior Scientist will be working within the Analytical Development and Attribute Sciences division within the Biologics Development (BD) organization. The role will involve the development, qualification and transfer of analytical separation methods used for product release, stability studies and process characterization supporting late phase programs. The successful candidate should be self-motivated, have excellent communication skills, be a team player, and have knowledge and experience in protein chemistry and bioanalytical techniques including chromatographic and electrophoretic separations. The candidate will actively partner with theanalytical characterization team, early assets analytical development team, Manufacturing Science & Technology, Data Analytics, Project Management, and quality groups in a matrix, team organization to establish a best in class analytical development organization, ensuring scientific excellence. Desired skills include Design of Experiment (DoE), HPLC/UPLC, LC-MS, Capillary Electrophoresis (CGE, cIEF), SDS-PAGE, as well as biophysical characterization and biological techniques. Knowledge and experience with protein / peptide characterization and molecular and cell biology would be a plus. The role will also include opportunities to lead and direct more junior scientists.
This role will be located in Devens, MA.
- Mentor andpotentiallymanage more junior level scientists
- Demonstrated experience leading projects, teams, and collaborations
- Demonstrated problem solving skills
- Experience with cGMP as applied to analytical methods
- Proficientwith Design of Experiment (DoE) using JMP or other statistical software
- Proficient at the development, qualification, transfer and characterization of bio-analytical techniques for monoclonal antibodies, recombinant proteins and Advanced Therapy Medicinal Products (ATMPs) to support product release, stability and process characterization studies under targeted timelines. Author and oversee the authoring of method SOPs, development and qualification reports.
- Work collaboratively across organizations and sites for method readiness, transfer, performance and troubleshooting supporting late phase development projects.
- Authors and reviews analytical method and validation sections in IND filing documents
- Utilize statistical tools for Design of Experiment (DoE) to optimize assay conditions and evaluate assay robustness, and to analyze and trend development data.
- Actively lead and work on internal initiatives for improvement of business processes.
- Actively communicate with vendors to assess new technologies for implementation into our development workflows. Evaluate these technologies and lead scientific and technological innovations for process improvement.
- Work closely with commercial development teams supporting commercial method validation and BLA filings.
The successful candidate will have
- Degree in Biochemistry, Biotechnology, Analytical Chemistry, Molecular Biology, Virology, Chemical / Biological / Biochemical Engineering or a related discipline.
- PhD with 3+ years experience, MS with 8+ years or BS with 10+ years experience in the Biotech and/or Biopharmaceutical industry
- A strong background in the areas of analytical chemistry/biochemistry, with the emphasis on experience and in-depth working knowledge of CE, iCE, and HPLC/UPLC (UV/FL/CAD/MS).
- Experience with protein fragmentation (CGE, RPLC), charge variants (AEX/CEX/CIEF/iCIEF), N-glycans, peptide mapping and aggregation/HMW analysis (Size Exclusion Chromatography) techniques is highly desirable.
- Experience with mass spectrometry and biophysical characterization is a plus.
- Experience with PCR, ELISA, Western Blotting, Cell based bioassay is a plus.
- Working knowledge of design of experiments and basic statistical knowledge is desirable.
- Familiarity with biologics process and regulatory requirement for biologics development.
- Knowledge of cGMPs as applied to analytical development and testing.
- Development experience for both early- and late-stage programs is highly desirable.
- Excellent communication and interpersonal skills.
- Works independently and collaborates with other groups. Deliver results in line with project and team objectives.
- This role requires office work, biochemical laboratory work, computer work, group meetings, and thus involves the following: sitting, standing, walking, working with analytical instruments, repetitive motion including bending and lifting small containers/equipment's.
- Working in an analytical laboratory handling chemical reagents that may be hazardous (corrosive, toxic, flammable etc.).
- Office work, teleconferencing, computer work, leading meetings requiring working in open office environment, working alone and working with/around others.
- This position may require occasional travel.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 with the resources to pursue their goals, both at work and in their personal lives.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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