Senior scientist
Company Name:
Bristol Myers Squibb
Title: SENIOR SCIENTIST
Location: NA-US-NJ-Hopewell
Job Number: 1405586
Bristol-Myers Squibb is the world leader in Biotherapeutics for Immuno-Oncology. The Bioassay Center of Excellence is the global center for biological potency assay development, biological characterization and clinical lot release. To enable the continuous expansion of our biologics pipeline, we are looking for experienced professionals passionate about bringing recombinant therapeutics to patients to address significant unmet medical need. Candidate has the opportunity to drive state-of-the art potency assay applications that support the company's portfolio of preclinical, clinical- stage and commercial biologics. The role calls for close collaboration with early development, process sciences groups, internal analytical functions, as well as with Manufacturing Sciences and Technology and the Clinical as well as Commercial Quality Assurance organization.
Responsibilities:
Accountable for bioassay applications for early and late stage development programs, assay qualification/validation, troubleshooting, critical reagent and Reference standard strategy, overseeing lot release and stability analysis, direct supervision of scientific staff, and collaboration with stakeholders in partner organizations.
Leads activities in clinical cGMP organization and supports technical activities for commercial biotech drugs.
Inspires innovation and operational excellence and fosters a continuous learning environment.
Authors technical sections in regulatory submissions as applicable.
Translates strategy into actionable objectives, and anticipates and addresses technical, regulatory, and other business needs.
Qualifications:
Advanced degree in immunology, cell biology, molecular biology or equivalent experience.
Typically at least 6-8 years directly applicable experience in biopharmaceuticals.
Technical knowledge of cell-based bioassays for CMC applications.
cGxP experience and a sense for compliance.
History of rigorous technical accomplishments.
Strong interpersonal and communication skills.
Understanding of regulatory and industry guidelines in the area of potency assay development and validation.
Capability to drive change and influence internal and external stakeholders Job: Process DevelopmentEstimated Salary: $20 to $28 per hour based on qualifications.
Bristol Myers Squibb
Title: SENIOR SCIENTIST
Location: NA-US-NJ-Hopewell
Job Number: 1405586
Bristol-Myers Squibb is the world leader in Biotherapeutics for Immuno-Oncology. The Bioassay Center of Excellence is the global center for biological potency assay development, biological characterization and clinical lot release. To enable the continuous expansion of our biologics pipeline, we are looking for experienced professionals passionate about bringing recombinant therapeutics to patients to address significant unmet medical need. Candidate has the opportunity to drive state-of-the art potency assay applications that support the company's portfolio of preclinical, clinical- stage and commercial biologics. The role calls for close collaboration with early development, process sciences groups, internal analytical functions, as well as with Manufacturing Sciences and Technology and the Clinical as well as Commercial Quality Assurance organization.
Responsibilities:
Accountable for bioassay applications for early and late stage development programs, assay qualification/validation, troubleshooting, critical reagent and Reference standard strategy, overseeing lot release and stability analysis, direct supervision of scientific staff, and collaboration with stakeholders in partner organizations.
Leads activities in clinical cGMP organization and supports technical activities for commercial biotech drugs.
Inspires innovation and operational excellence and fosters a continuous learning environment.
Authors technical sections in regulatory submissions as applicable.
Translates strategy into actionable objectives, and anticipates and addresses technical, regulatory, and other business needs.
Qualifications:
Advanced degree in immunology, cell biology, molecular biology or equivalent experience.
Typically at least 6-8 years directly applicable experience in biopharmaceuticals.
Technical knowledge of cell-based bioassays for CMC applications.
cGxP experience and a sense for compliance.
History of rigorous technical accomplishments.
Strong interpersonal and communication skills.
Understanding of regulatory and industry guidelines in the area of potency assay development and validation.
Capability to drive change and influence internal and external stakeholders Job: Process DevelopmentEstimated Salary: $20 to $28 per hour based on qualifications.
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