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.

The Manufacturing Aseptic Processing Technical Manager is responsible for leading proactive monitoring initiatives, driving continuous improvement in aseptic techniques, and ensuring compliance with relevant regulations and internal standards. 

This role requires collaboration with Quality Assurance, Quality Control, MSAT, and Manufacturing Operations to support environmental and personnel monitoring excursion investigations, identify root causes, and implement corrective actions to improve contamination controls within the Cell Processing Facility.

Key Responsibilities

• Support deviation investigations (environmental monitoring excursions and personnel monitoring excursions) as the manufacturing SME to identify root causes and corrective actions.
• Represent Manufacturing as a decision maker in cross-functional meetings, including IRB, CRB, and CCRB.
• Perform floor gembas to identify gaps in aseptic processing and implement corrective actions to improve aseptic techniques and behaviors, as well as reduce contamination risks.
• Provide on-the-floor process support for validation activities (Aseptic Processing Simulation and Non-Routine Sampling activities).
• Author or review technical documentation (e.g., investigations, change controls, SOPs, impact assessments, batch records, and validation reports).
• Support health authority and/or internal inspections as the aseptic process SME.
• Train end-users and entry-level personnel on the manufacturing process and aseptic techniques and behaviors within the ISO 5/7 (Grade A/B) environment.
• Establish environment and personnel monitoring KPIs and drive Right First Time Reduction.
• Ensure aseptic best practices are embedded with new product introduction technology transfer.

WORKING CONDITIONS (US Only):

• Must be able to work in a cleanroom environment that requires gowning within ISO 5/7 (Grade A/B).
• Must be able to stand for extended periods of time.
• Work in areas that may have strong magnets.
• Work in areas where handling human blood products (Biosafety Level 2) may be required.
• May work in areas with exposure to vapor phase liquid nitrogen.
• Must be able to gown in and be present in the Grade A/B environment for extended periods of time.

Qualifications & Experience
Education/Experience:

• Master’s or Bachelor’s Degree in cell biology, biotechnology, biochemistry, microbiology, life sciences, or equivalent with a minimum of 5 years of relevant experience in biologic or cell therapy.
• Experience in a regulated, GMP manufacturing environment is required.
• Knowledge of regulatory requirements, including current Good Manufacturing Practices (cGMP), Good Practices (GxP), 21 CFR Part 11, Good Documentation Practices (GDP), and Annex 1.
• Experience with ergonomics relating to aseptic techniques and aseptic behaviors.
• Experience with electronic quality management systems.
• Experience with cleaning and sanitization practices.
• Familiarity with clean room design and qualification requirements.

Skills & Abilities:

• Knowledge of cGMPs. Cell therapy and aseptic processing experience is required.
• Ability to think strategically and translate strategy into actions.
• Ability to collaborate and influence cross-functional teams.
• Experience with leading change management is preferred.

The starting compensation for this job is a range from $113,930 to $138,100, plus incentive cash and stock opportunities