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Biologics Specification Committee Chair and Director of Analytical Team Leads

Company: Bristol-Myers Squibb
Location: Ontario
Posted on: September 17, 2020

Job Description:

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through 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. Description 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 Director of (ATL's) and clinical BSC chair is responsible for leading a team of ATL's within Biologics Development and chairing the biologics specification committee (BSC-clinical phase). Critical responsibilities of this individual include developing organizational and scientific strategy to support the analytical project teams to assure that the quality and timliness of analytical deliverables are at or above industry benchmarks. The director assures all biologics CMC analytical deliverables are met for projects that initiate at clone selection and advance through BLA filing. The leader accomplishes this by implementing business processes and driving a culture of deep scientific understanding, use of best practices, and continuous improvement. The director empowers and enables analytical team leads, and fosters an environment of high performance. The ATL Network Lead assures integrated delivery of the biologics portfolio in collaboration with process and formulation leaders. As a member of the Biologics ELT, this individual is expected to demonstrate enterprise mindset and behaviors. This individual contributes to decisions on Biologics capital, staffing, and talent investments. Bristol-Myers Squibb is the industry leader in immuno-oncology with life-saving medicines such as Opdivo, Yervoy, and Empliciti and a rich clinical portfolio of diverse modalities including monoclonal antibody, fusion protein, gene delivery, and combination therapies. Key_Responsibilities This leader will be directly accountable for managing delivery and timeline of the biologics analytical portfolio at multiple sites in NJ and MA. This includes integration of method development, structural and functional characterization, release testing, comparability, stability studies, regulatory filings, and related activities. The Lead will work closely with SME's and leaders across biologics development groups, to optimize department business operations, and deliver on the analytical strategy of the programs that ATL's oversee. This individual will have 8-12 direct reports (ATL's). * Chair the Biologics Specification Committee (BSC) to facilitate the technical evaluation and approval of specification documents (Justification of Specification, JoS) by the BSC in support of in- process, release and stability testing of drug substances, drug products, and placebos within the BMS portfolio from FIH through BLA filing * Lead the strategic evolution of the BSC by evaluating and incorporating emerging and current industry concepts to improve the technical/ scientific aspects of JoS documents/specifications * Lead the business process evolution of the BSC with the use of operational excellence and program management tools * Lead and/or participate in opportunities to build, define and improve associated specification processes that interface with the BSC business or scientific process including the Critical Quality Attributes Council and Integrated Biologics Technical Review forums * Develop templates, standards and/or procedures to support the robust development of a specification document * Document or revise existing documents governing the CSC in directives, SOPs or technical documents to support operations and scientific strategy * Communicate with ATLs/APLs/IDTs/TPTs/CSC members and other stakeholders on an individual and collective basis for the purpose of knowledge sharing and continuous improvement Key_Competencies/Qualifications * PhD or MS in analytical science, biochemistry, pharmaceutical sciences, biology, or related discipline, plus at least 8 years of experience in Biologics CMC development * Proven leader with experience in managing matrix teams in a technical environment. * Strong program management and project management skills and adept at working collaboratively with cross functional teams * Strong experience with portfolio management & prioritization, resource modeling, and expertise with different tools like Timeline Maker, Tableau, spotfire are desirable. * Strong interpersonal and communication skills and knowledge of analytical and biochemical techniques, chromatography, biological function and biologics characterization * Experience in oversight of CMOs/CROs for biologics method development, characterization, technology transfer, and release * Knowledge of biologics CMC development from pre-clinical through clinical to commercialization 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. Show moreShow less

Keywords: Bristol-Myers Squibb, Ontario , Biologics Specification Committee Chair and Director of Analytical Team Leads, Executive , Ontario, California

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