Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us .
Business Unit Summary
Our Biologics Development team is responsible for development and transfer of safe, efficient, and approvable biologics drug substance manufacturing processes and analytical methods for all of BMS' biologics portfolio. We work closely with other BMS units to support our clinical pipeline through to late stages of clinical development. Innovation is at the core of what we do, with an intense focus on efficiency, speed, robustness, and approvability of our processes and methods. Here, you'll get the chance to grow and thrive through opportunities uncommon in scale and scope, pursue innovative ideas, and advance professionally alongside some of the brightest minds in Biopharma.
Position Summary
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.
Key Responsibilities
The Senior Director, Head of Potency and Impurity Assay Development (PIAD), Biologics Development leads the organization that enables activities cross-functionally, including:
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.
Qualifications & Experience
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
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
Devens - MA - US: $245,680 - $297,711 New Brunswick - NJ - US: $229,610 - $278,234
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: 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.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy @type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1595017
Updated: 2025-09-14 04:44:29.518 UTC
Location: Devens-MA
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
