Bristol Myers Squibb
Senior Director, Head of Potency and Impurity Assay Development
Bristol Myers Squibb, New Brunswick, New Jersey, us, 08933
Senior Director, Head of Potency and Impurity Assay Development
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Challenging. Meaningful. Life-changing. Those words reflect the impact of our work as we transform patients' lives through science. This role offers opportunities to grow and contribute at scale alongside high-achieving teams in Biologics Development. Position Summary
The Senior Director, Head of Potency and Impurity Assay Development (PIAD) reports to the Vice President, Biologics Development and leads the potency and impurity assay development strategy within the Biologics Development Leadership Team. The role manages a team of subject matter experts to orchestrate CMC potency and impurity strategy and structure-function understanding of product quality. Responsibilities span pre-clinical through commercial stages, collaborating with early discovery, process sciences, analytical, Manufacturing Sciences and Technology, and Quality organizations. The leader is expected to develop talent and advance scientific contributions while building the next generation of leaders. Key Responsibilities Oversee CMC Potency and Impurity Strategy and develop industry-leading potency and impurity methods enabling end-to-end manufacture, release and stability testing, and structure-function understanding. Accountable for clinical GMP testing of potency and impurity assays for lot release and stability, including quality management system compliance. Optimize, validate, and transfer validated methods to commercial quality laboratories and contract testing laboratories. Oversee biological characterization strategy and execution for biotherapeutics from pre-IND through licensure. Develop scientific strategies to support regulatory acceptance of biological assays and impurity methods; accountable for relevant regulatory sections in filings and responses. Collaborate with analytical development on CMC activities such as comparability, structure-function assessments, impurity clearance validation, and Reference Standard qualification. Oversee analytical cell line development, vector design, cell banking and qualification. Drive strategic execution of the biotherapeutics portfolio to develop and transfer safe, efficient, and approvable DS manufacturing processes. Manage financial aspects of the Biologics Development budget, including operational, capital equipment, outsourcing and resource management. Serve as a key member of the Biologics Development leadership team, guiding best practices and continuous improvement. Create an environment that attracts, develops, retains and promotes diverse scientific talent; lead a team of 30-40 scientists (direct and contractor) and foster a culture of learning and operational excellence. Qualifications & Experience PhD in immunology, cell biology, molecular biology or equivalent with 15+ years of relevant experience, or Master’s/Bachelor’s with 18+ years in biotechnology. Deep understanding of molecular mechanism of action for protein therapeutics. Broad technical knowledge of biological and impurity assay development across multiple modalities. Minimum of 12+ years in CMC potency and impurity development with cGxP experience, analytical method validation, quality system management, and global regulatory filing requirements. Minimum of 15+ years’ experience leading functional and/or cross-functional teams and direct people management experience. Strong scientific rigor, organizational and project management skills, and excellent interpersonal communication. Proven track record of continuous improvement, scientific contributions, and development of high-performing teams. Location & Compensation
Devens, MA or New Jersey locations with applicable remote work as per policy. The starting compensation range is listed on the role posting and may include incentive cash and stock opportunities based on eligibility. Final compensation will reflect experience and other factors. Benefits and other details are provided on the careers site. Equal Employment Opportunity
BMS is committed to providing reasonable accommodations in our recruitment process and in the workplace. Applicants can request accommodations if needed. Visit our careers site for the full Equal Employment Opportunity statement.
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Join to apply for the Senior Director, Head of Potency and Impurity Assay Development role at Bristol Myers Squibb. Working with Us
Challenging. Meaningful. Life-changing. Those words reflect the impact of our work as we transform patients' lives through science. This role offers opportunities to grow and contribute at scale alongside high-achieving teams in Biologics Development. Position Summary
The Senior Director, Head of Potency and Impurity Assay Development (PIAD) reports to the Vice President, Biologics Development and leads the potency and impurity assay development strategy within the Biologics Development Leadership Team. The role manages a team of subject matter experts to orchestrate CMC potency and impurity strategy and structure-function understanding of product quality. Responsibilities span pre-clinical through commercial stages, collaborating with early discovery, process sciences, analytical, Manufacturing Sciences and Technology, and Quality organizations. The leader is expected to develop talent and advance scientific contributions while building the next generation of leaders. Key Responsibilities Oversee CMC Potency and Impurity Strategy and develop industry-leading potency and impurity methods enabling end-to-end manufacture, release and stability testing, and structure-function understanding. Accountable for clinical GMP testing of potency and impurity assays for lot release and stability, including quality management system compliance. Optimize, validate, and transfer validated methods to commercial quality laboratories and contract testing laboratories. Oversee biological characterization strategy and execution for biotherapeutics from pre-IND through licensure. Develop scientific strategies to support regulatory acceptance of biological assays and impurity methods; accountable for relevant regulatory sections in filings and responses. Collaborate with analytical development on CMC activities such as comparability, structure-function assessments, impurity clearance validation, and Reference Standard qualification. Oversee analytical cell line development, vector design, cell banking and qualification. Drive strategic execution of the biotherapeutics portfolio to develop and transfer safe, efficient, and approvable DS manufacturing processes. Manage financial aspects of the Biologics Development budget, including operational, capital equipment, outsourcing and resource management. Serve as a key member of the Biologics Development leadership team, guiding best practices and continuous improvement. Create an environment that attracts, develops, retains and promotes diverse scientific talent; lead a team of 30-40 scientists (direct and contractor) and foster a culture of learning and operational excellence. Qualifications & Experience PhD in immunology, cell biology, molecular biology or equivalent with 15+ years of relevant experience, or Master’s/Bachelor’s with 18+ years in biotechnology. Deep understanding of molecular mechanism of action for protein therapeutics. Broad technical knowledge of biological and impurity assay development across multiple modalities. Minimum of 12+ years in CMC potency and impurity development with cGxP experience, analytical method validation, quality system management, and global regulatory filing requirements. Minimum of 15+ years’ experience leading functional and/or cross-functional teams and direct people management experience. Strong scientific rigor, organizational and project management skills, and excellent interpersonal communication. Proven track record of continuous improvement, scientific contributions, and development of high-performing teams. Location & Compensation
Devens, MA or New Jersey locations with applicable remote work as per policy. The starting compensation range is listed on the role posting and may include incentive cash and stock opportunities based on eligibility. Final compensation will reflect experience and other factors. Benefits and other details are provided on the careers site. Equal Employment Opportunity
BMS is committed to providing reasonable accommodations in our recruitment process and in the workplace. Applicants can request accommodations if needed. Visit our careers site for the full Equal Employment Opportunity statement.
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