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.
Position Summary:
This leader will shape the operational culture from the ground up, ensuring the site is staffed with exceptional talent, achieves operational readiness on an aggressive timeline, and continuously delivers operational excellence in a highly regulated, patient-centric environment.
As the Associate Director of the Aseptic Observation Program, you will provide strategic leadership and direction for the team responsible for overseeing aseptic practices within Cell Therapy manufacturing cleanrooms and supporting environments. You will be accountable for ensuring that operators, verifiers, and support personnel consistently demonstrate proper aseptic techniques and behaviors, in line with the principles outlined in the Contamination Control Strategy. This role is instrumental in defining, reinforcing, and maintaining standards that prevent personnel-related risks to the manufacturing environment.
In this capacity, you will directly support and guide the Aseptic Observation Program Leads, fostering the development of a high-performing team of observers. Your leadership will drive collaboration with Manufacturing, Quality Assurance, Training, and other cross-functional teams to advance aseptic performance and uphold a culture of excellence in quality and manufacturing. You will be responsible for identifying and addressing behavior drift, providing real-time constructive feedback, and coaching personnel to ensure continuous improvement. Additionally, you will analyze trends in aseptic performance, contribute to root cause analysis, and champion initiatives that strengthen contamination control and operational effectiveness.
Key Responsibilities:
Provide strategic leadership and oversight to the aseptic observer team, guiding and mentoring team Leads to ensure effective execution of their responsibilities and alignment with organizational objectives.
Lead the implementation and continuous enhancement of aseptic observation processes on the manufacturing floor, evaluating operator behaviors, aseptic technique, and compliance with Contamination Control Strategy principles.
Establish robust documentation practices for observations, delivering actionable coaching and feedback to both personnel and area management to drive sustained improvements in aseptic performance.
Collaborate with Sterility Assurance, Manufacturing, and Quality teams to optimize observation procedures, operational SOPs, and comprehensive training programs that reinforce best practices.
Represent the Aseptic Observation Program in cross-functional meetings, presenting key insights and recommending process optimizations based on trend analysis and observational data.
Champion enhancements to the Contamination Control Strategy, including the development and dissemination of aseptic processing methodologies, gowning standards, and cleanroom behavioral expectations.
Direct the creation and revision of aseptic training materials, incorporating real-world scenarios and lessons learned from observations to increase engagement and effectiveness among manufacturing staff.
Oversee the planning and delivery of targeted training sessions, ensuring challenges identified through observation are addressed and best practices are reinforced across the organization.
Analyze trends in aseptic performance, lead the identification of systemic issues, and drive continuous improvement initiatives to elevate operational excellence.
Review and synthesize aggregated observation data to identify recurring challenges, propose strategic corrective actions, and monitor the impact of implemented solutions over time.
Lead root cause analysis, CAPA development, and deviation investigations related to aseptic practices, providing expert guidance and supporting the design of effective preventive measures.
Partner with investigation teams to deliver comprehensive observation insights, facilitate fact-finding, and ensure the adoption of robust preventive strategies.
Oversee the execution and closure of corrective actions resulting from observations, ensuring timely resolution and long-term sustainability of improvements in aseptic practices.
Ensure regulatory inspection readiness by maintaining accurate observation records, rigorous documentation standards, and demonstrable program effectiveness.
Stay abreast of industry best practices, evolving regulatory requirements, and emerging trends in aseptic processing, proactively strengthening the observation program and Contamination Control Strategy.
Qualifications required:
Specific Knowledge, Skills, Abilities:
Demonstrated success in building and scaling operations teams, including hiring, training, and developing frontline and leadership talent
Strong command of operational excellence methodologies (Lean, Six Sigma), daily management systems, and KPI-driven leadership
Effective cross-functional collaboration and communication skills; ability to translate complex technical requirements into clear operational plans
Proven proficiency in coaching and providing feedback for front line operators is required.
Extensive knowledge of SOPs and cGMPs and the know–how to work and manage within a regulatory environment.
Understanding of aseptic processing principles, cleanroom behavior standards, and contamination control strategies.
Strong observational, analytical, and critical-thinking abilities.
Adaptable to a fast-paced, complex, and ever-changing business environment.
Education/Experience/ Licenses/Certifications:
Bachelors in relevant science or engineering discipline, or equivalent in work experience.
8 – 12 years of experience in cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience.
In-depth understanding of cGMP, aseptic processing principles, contamination control strategies, and data integrity requirements
Experience in the following is highly preferred:
Cell therapy manufacturing observations, training, or management.
Aseptic processing in ISO 5/Grade A biosafety cabinets.
BMSCART
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:
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 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 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/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
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/
Data Protection
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R1600242 : Associate Director, Aseptic Observation Program