Senior Scientist, Bioassay Development – Bioassay Center of Excellence (R1558136-en-us)
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.
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.
The Bioassay Center of Excellence is the global center for potency assay development, biological characterization and clinical lot release for biotherapeutics. The Senior Scientist role in the Bioassay Center of Excellence will drive development of state-of-the art bioassays that support the company portfolio of preclinical and clinical-stage biotherapeutics. This role requires a strong understanding of immunology/virology/molecular biology and expertise with the design and development of functional assays. The role calls for close collaboration with early discovery groups, process science groups, internal analytical functions, as well as with manufacturing sciences and technology, and quality organizations.
Responsibilities will include, but are not limited to, the following:
- Directly accountable for bioassay development for early- and late-stage development programs, development of fit-for-purpose biological characterization assays, and assay qualification/validation/transfer.
- Develops or contributes to biological characterization strategies for protein therapeutics pre- and post-IND through licensure
- Develops or contributes to sound scientific strategy to support regulatory acceptance of biological assays in clinical development.
- Participates in associated CMC activities such as biological comparability and structure-function assessments of biotherapeutics.
- Responsible for generation and documentation of results in a GMP-compliant environment.
- Responsible for experimental design, execution, data review and analysis, document writing, and contribution to regulatory submissions.
- Collaborates with stakeholders in partner organizations on technical and strategic activities.
- PhD in virology, immunology, or equivalent experience
- Depth of understanding of molecular mechanism of action for biotherapeutics
- Knowledge and experience with lentiviral and AAV biology
- Technical experience with biological assay development across multiple molecular modalities
- Demonstrated method development experience with viral infectivity assays and cell-based assays
- Demonstrated experience with RT-PCR, qPCR, and/or ddPCR
- Minimum of 4-5 years directly related experience in biopharmaceutical development
- Knowledge of cGxP requirements preferred
- Strong history of rigorous science applied to drive technical accomplishments
- Strong organizational and project management skills
- Strong interpersonal and communication skills
- Track record of scientific accomplishments and publications
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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 if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.
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