Senior Specialist – Clinical Site MSAT

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 rich in diversity. Take your career farther than you thought possible.

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Title: Senior Specialist – Clinical Site MSAT

Location: Warren, NJ

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Senior Specialist, Clinical Site Manufacturing, Science and Technology (MSAT) is responsible for leading investigations in support of Manufacturing Operations at the Warren, NJ site. This position will be assigned more complex deviation investigations, facilitating teamwork to execute all components within applicable timelines. Deviation investigations will include execution of thorough root cause analyses (RCA) as well as identification of corrective and preventative actions (CAPA) across multiple platforms / programs.

In addition, the role requires consistent compliance within various quality programs / systems, including but not be limited to training, trending, and process / continuous improvements. The position will interface closely with functional teams at the site to drive timeline adherence activity as it pertains to an investigation.

Key Responsibilities:

Under the direction of the Senior Manager, work independently and cross-functionally to perform the following:

• Conduct thorough investigations utilizing root cause analysis tools
• Lead investigations with the ability to summarize progress to Site Leadership through the collection of triage information and supporting data from both technical and quality teams
• Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness
• Ensure all investigations are completed within system timelines
• Notify stakeholders of delays / risks upon discovery
• Lead deviation investigation defense during audits and site inspections as deemed necessary by Management
• Manage complex issues and solve problems with minimal guidance
• Manage teams to support complex investigations
• Provide mentorship, guidance, and training to junior members
• Continuously living the “Patients First” mission and fostering a “Right First Time” mindset
• Initiate change control documentation if needed

Qualifications & Experience:

• Requires a bachelor’s degree in science or engineering (advanced degree preferred)
• Minimum 7 years of relevant work experience, preferably in a health authority regulated environment
• Requires demonstrated capability in medium and high-risk deviation reports or equivalent proven experience
• Previous experiences working in a biopharmaceutical manufacturing facility and an aseptic environment is preferred (CAR T a plus)

• Advanced working experience of deviation investigations utilizing root cause analysis tools
• Working experience in the CAPA process and ability to identify and verify effectiveness
• Capability to kickoff and lead limited duration investigation teams, to ensure timely completion of more complex investigations

• Proven ability to understand, follow, interpret, and apply accurately and completely

Global Regulatory and cGMP requirements

• Knowledge of data trending and tracking
• Demonstrate advanced problem-solving technique