Specialist, Aseptic Observation Program

Bristol Myers Squibb • Summit, NJ

1d • Onsite

About The Position

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.

Requirements

• 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.
• Bachelors in relevant science or engineering discipline, or equivalent in work experience.
• 3+ years of experience in cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience.

Nice To Haves

• Cell therapy manufacturing observations, training, or management.
• Aseptic processing in ISO 5/Grade A biosafety cabinets.

Responsibilities

• Performing aseptic observations on the manufacturing floor to assess operator behaviors, aseptic technique, and adherence to the Contamination Control Strategy principles.
• Documenting observations accurately and providing actionable coaching and feedback for observed personnel and area management.
• Demonstrating a strong practical and theoretical knowledge in their work.
• Actively seeking opportunities to increase understanding of cGMP and aseptic principles to be able to better provide feedback for operators.
• Partnering with Sterility Assurance, Manufacturing, and Quality teams to refine observation procedures, operational SOPs, and training programs.
• Supporting improvements to the Contamination Control Strategy including aseptic processing concepts, gowning practices, and cleanroom behavior expectations.
• Contributing to the revision of aseptic training materials, leveraging real-world examples from observations to enhance learning and engagement for manufacturing staff.
• Assisting in delivering training sessions to reinforce proper techniques and address observed challenges.
• Participating in root cause analysis, CAPA development, and deviation investigations related to aseptic practices.
• Collaborating with investigation teams to provide detailed observation insights, support fact-finding efforts, and help design effective preventive measures.
• Monitoring the implementation of corrective actions arising from observations, ensuring timely closure of action items and sustained improvement in aseptic practices.
• Supporting regulatory inspection readiness through observation records and documentation accuracy.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level