Senior Director, Head of Potency and Impurity Assay Development

Bristol-Myers Squibb • New Brunswick, NJ

103d • $229,610 - $297,711 • Hybrid

About The Position

The Senior Director, Head of Potency and Impurity Assay Development (PIAD) reports to the Vice President, Biologics Development (BD) and serves as the strategic leader for potency and impurity assay development within the Biologics Development Leadership Team. The individual will lead a dedicated team of subject matter experts to orchestrate and execute, within the network, CMC potency and impurity strategy and structure-function understanding of product quality in close collaboration with other BD analytical functions. This role is responsible for managing and delivering key CMC potency and impurity milestones from pre-clinical through commercial stage biotherapeutics. The role calls for close collaboration with early discovery groups, process sciences groups, internal analytical functions, Manufacturing Sciences and Technology, and Quality organizations. This leader is an expert talent developer and a recognized scientific professional in the field - building and advancing scientific contributions and developing the next generation of scientific and organizational leaders.

Requirements

• PhD in immunology, cell biology, molecular biology or equivalent with 15+ years of relevant experience or Master's/Bachelor's degree with 18+ years of applicable experience in biotechnology industry.
• Depth of understanding of molecular mechanism of action for protein therapeutics.
• Broad technical knowledge of biological assay development across multiple molecular modalities.
• Broad technical knowledge of impurity assay development across multiple molecular modalities.
• Minimum of 12+ years in CMC potency and impurity development, including 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.
• Minimum of 15+ years experience direct people management experience.
• Experience in developing talent, managing change, engaging and motivating people.
• Strong history of rigorous science applied to drive technical accomplishments.
• Strong organizational and project management skills.
• Strong interpersonal and communication skills.
• Track record of driving continuous improvement.
• Track record of scientific accomplishments and publications.
• Demonstrated leadership capabilities to develop a high-performing team, drive change and influence internal and external stakeholders.
• Operational focus, as well as ability to develop strategies and manage ambiguity.

Responsibilities

• Oversight and accountability for CMC Potency and Impurity Strategy, development of industry-leading potency and process impurity methods enabling end-to-end manufacture, release and stability testing, and structure-function understanding.
• Accountable for clinical GMP testing of relevant potency and impurity assays for lot release and stability, associated quality management system compliance.
• Accountable for optimization, validation, and transfer of validated methods to commercial quality laboratories and contract testing laboratories.
• Oversight and accountability for biological characterization strategy and execution for biotherapeutics pre- and post-IND through licensure.
• Development of sound scientific strategy to support regulatory acceptance of biological assays and impurity methods in clinical development.
• Accountable for relevant regulatory sections of regulatory filings and responses to queries.
• Partners across analytical development on CMC activities such as analytical comparability, structure-function assessments of biotherapeutics, impurity clearance validation strategy, Reference Standard qualification.
• Oversight of analytical cell line development, vector design, cell banking and qualification.
• Drives strategic execution of biotherapeutics portfolio book-of-work in collaboration with partner BD functions to develop and transfer safe, efficient, and approvable Biologics DS manufacturing processes.
• Responsible for financial stewardship of relevant components of Biologics Development budget, including operational, capital equipment, travel, outsourcing, and resource management expenses.
• Serves as a key strategic member of the Biologics Development leadership team.
• Continually assesses functional area capabilities and processes and provides guidance for best practices and direction for continuous improvement.
• Creates an environment that attracts, develops, retains and promotes diverse scientific talent.
• Leads a team of 30-40 diverse scientists (direct and contractor), develops talent, inspires innovation and operational excellence.
• Fosters a continuous learning environment.

Benefits

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree