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.
Among our several NJ locations, our Hopewell and Bloomsbury sites are key components of the Biologics Network Strategy, with available Process Development and Analytical Development & Testing opportunities to support the innovating biologics under development.
The Analytical Team Leader/Biologics will provide scientific leadership within and across functional areas that coordinates analytical activities to support the Molecular and Analytical Development organization.
Develop analytical strategy to support the Integrated Development Team (IDT) for CMC product development.
Establish project specific CMC timelines within MAD to support IDT strategies.
Ensure timely delivery of project specific analytical packages supporting IDT activities.
The Analytical Team Leader will lead and manage programs from preclinical development through late stage clinical development.
This role requires close collaboration with MAD and external departments, including teams in Process Sciences, Drug Product Science and Technology, Manufacturing Sciences and Technology, Clinical Supply Organization, Drug Safety Evaluation, and CMC-Regulatory.
Direct accountable for all project specific analytical-related activities at all Central New Jersey sites including method development, technical transfer, release testing, extended characterization, comparability studies, formulation and process development support, stability studies, regulatory filings, and sample distribution supporting the above activities.
Provide analytical expertise and knowledge of biopharmaceutical development process to support and drive analytical CMC activitiesParticipate in an IDT consisting of analytical, manufacturing, process development, quality, regulatory, supply chain, etc.
Work with other groups to develop timelines, budgets and effective strategies to meet the clinical supply demands and supply chain needsManage & track the development and qualification of analytical methodsCoordinate the specifications development process, prepare the specification package documents, drive the process to approve the specificationsCoordinate analytical support for process and formulation developmentProvide clear, concise, and timely communications with the IDT and analytical managementMaintain proficiency in the biological drug development process including a thorough understanding of the molecular attributes, target quality profiles and linking them to patient safety and efficacy aspectsAuthor, edit & review sections/documents for regulatory submission:
IND and CTAs, and respond to regulatory submissions Qualifications Minimum Requirements:
MS or PhD in biology, biochemistry, analytical chemistry or equivalent disciplineMinimum of 4-10 years of experience in Biologics developmentStrong knowledge of Biochemical principles, Chromatography, Protein chemistryProven leader with experience managing highly technical, matrix teamsStrong interpersonal and communication skillsExperience in oversight of CMOs for drug substance and drug product manufacturing as well as for method development, characterization and technology transferMust have excellent trouble-shooting capabilitiesMust have experience resolving technical issues Bristol-Myers Squibb is an equal opportunity employer - M/F/Vet/DisabilityRequisition ID - 1500291

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