Senior Manager, Senior Process Validation Engineer, Cell Therapy

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.

The Senior Manager provides process validation support to the Devens Cell Therapy Facility (CTF). The Senior Manager leads and participates in facility and process validation activities, including process tech transfers and lifecycle management changes.

• Lead Process Validation activities including Product Lifecycle Management changes, Process Performance Qualifications (PPQ), microbial hold studies, and comparability studies.
• Serve as a technical subject matter expert for facility start‑up, technology transfer, and process validation.
• Perform data analysis, including the use of statistics, and prepare written protocols, reports and summaries supporting validation studies.
• Support equipment and facility commissioning, qualification and validation.
• Lead and own complex site Change Controls.
• Participate in and lead facility and process risk assessments and author qualification/validation documents (e.g., procedures, protocols and reports) in accordance with internal and external regulatory expectations.
• Support investigations and global change controls as required.
• Ensure safe and compliant cGMP operations, maintain permanent inspection readiness, and actively support regulatory inspections as a subject matter expert.
• Identify, prioritize and drive continuous improvements that reduce safety risks, operational costs, lead times, scrap, and discrepancy rates across all aspects of production, promoting problem identification and meaningful solutions through a culture of proactive problem prevention.
• Serve as an MS&T representative on cross‑functional and multi‑site teams.
• Build and maintain effective collaborative relationships across the site and network, influencing site and network product/process life‑cycle programs.

This position reports to the Associate Director of Manufacturing Science and Technology Validation.

• Proficient in cGMPs and multi‑national biopharmaceutical/cell therapy regulations.
• Proficient in facility/clean room design, process, equipment, automation, and process validation.
• Proficient in assessing and implementing product lifecycle changes and leading cross‑functional teams.
• Proficient in authoring regulatory submissions.
• Experience with internal and health authority audits, particularly pre‑licensure inspections (PLIs).
• Excellent verbal and written communication skills and ability to influence at all levels.
• Ability to think strategically and translate strategy into actions.

Required Qualifications (Candidates not meeting these requirements will not be considered):

• Minimum of a Bachelor's degree in science, engineering, biochemistry, or related discipline.
• Minimum of 8 years of direct experience in biopharmaceutical operations, including hands‑on work in cGMP manufacturing environments. Related or equivalent experience in other industries does not satisfy this requirement.

Devens – MA – US: $139,480 – $169,013 for a full‑time employee. 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…