Associate Director, Drug Product Analytical Science and Technology

Associate Director, Drug Product Analytical Science and Technology

Seattle 400 Dexter - WA - US

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.

Position Summary:

This leadership role will be responsible for the technical oversight of the analytical method lifecycle within the Cell Therapy Analytical Science and Technology organization. This role will lead a team of scientists providing analytical subject matter expertise to the commercial Quality Control organization during investigations, commercial drug product method validation and transfers, regulatory submissions and Health Authority interactions. In addition, the Associate Director role will oversee operational workflows, metrics, and quality events including actions and investigations.

Duties/Responsibilities:

• Lead and manage a team of analytical Subject Matter Experts (SME) responsible for the commercial drug product release methods utilized in the cellular biology, molecular and flow cytometry areas.
• Provide technical oversight and guidance to team as needed in support of method performance troubleshooting, evaluation of analytical test methods and data generated by internal and external laboratories, including investigations related to out of specification, out of trend, and aberrant results.
• Oversee method performance metrics and the team's completion of quality events including actions and investigations within electronic systems.
• Act as a Subject Matter Expert (SME) in functional areas as needed.
• Partner with analytical development and the commercial QC organization to identify method optimization and automation opportunities to enhance productivity and reduce the cost of product testing.
• Interface with analytical development functions on method qualification strategies.
• Hire, mentor, and develop exceptional ASAT personnel.

Reporting Relationship:

This position will report to the Director of Drug Product Analytical Sciences and Technology (ASAT), Cell Therapy.

Qualifications:

• Bachelor's degree in relevant scientific discipline or equivalent is required. Advanced degree preferred.
• 10+ years of relevant experience or equivalent combination of education and experience, preferably in a regulated environment (GMP), cellular therapy, or gene therapy and 2+ years' experience in Analytical Science.
• 5+ years of leadership experience
• Experience in analytical method lifecycle, including method transfer, validation, and maintenance.
• Advanced knowledge and implementation of Quality Management inclusive of SOPs, Change Controls, Deviations, CAPAs, Risk Assessments and data integrity principles.
• Advanced understanding of regulatory requirements and guidelines as related to the manufacture of cell therapy products (FDA, EMA, ICH, USP, and EP guidelines)
• Self-directed with a high degree of professional integrity, highly organized and detail oriented. Ability to work independently and to collaborate cross functionally to drive operational and quality excellence.
• Demonstrated leadership and management skills, including establishing strategic direction and goals, and guiding execution while fostering a team-based environment.
• Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences including ability to interpret and author general, technical, and complex business documents.
• Advance ability to communicate effectively with peers, department management, cross-functional peers.
• Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills.
• Ability to travel to other BMS sites or Partner sites is required.

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: $168,930 - $204,702 Seattle - WA: $173,660 - $210,439 Summit West - NJ - US: $157,880 - $191,312

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

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the 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.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities