Sr. Manager/Principal Engineer, Cell Therapy Process Validation

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.

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 candidate will be responsible for developing process validation standards, process qualification strategy and framework for cell therapy processes, continuous process verification (CPV) strategy and implementation in a consistent manner across products and sites. The candidate will also provide technical oversight for initial process performance qualification (PPQ) as well as throughout the product life cycle.

Key Responsibilities

• Interface with the Site MSAT and other validation counterparts in the biologics and small molecule networks to leverage expertise and knowledge across modalities.
• Participate in execution activities across the network to ensure expertise is integrated into centers throughout the network and our process validation standards and master plans represent our continuous learning from the manufacturing experience.
• Contribute to the significant process validation-related investigations, troubleshooting efforts, and responses to emerging requirements or questions during health authority interactions.
• Participate in the development of process characterization and process control strategies as needed to ensure that the control strategies are consistent with the process validation standards and manufacturing requirements.
• The candidate will work in an office environment and will need to author complex documents and final reports.
• Develop and implement validation policies to define robust process validation program within the cell therapy product lifecycle.
• Participate in generation and approval of PPQ enabling deliverables generated during late-stage process development and characterization.
• Define process validation strategy for upcoming products and support PPQ execution in a multi-site commercial environment.
• Author CMC content for regulatory filings and participate in formal agency meetings.
• Represent validation on contract manufacturing projects, including vendor selection, process transfer and process validation. Direct responsibility for validation activities at contract manufacturing organizations (CMOs), including validation gap assessments during CMO selection and tech transfers
• Provide oversight via review and approval of site level deliverables, including Validation Master Plans, process validation protocols and risk assessments.
• Design qualification strategies to support novel applications of fill, filtration, sterilization and single-use disposable technologies.
• Develop and implement continuous process monitoring strategies and ensure process validation status throughout commercial lifecycle.
• Respond to site independent process validation troubleshooting issues and questions.
• Coordinate responses to health authority questions on process validation that require a coordinated response or implementation across cell therapy manufacturing.
• Work with process, analytical development and MSAT groups to review, approve the development of process characterization and process control strategies as needed to ensure that the control strategies are consistent with the process validation standards and manufacturing requirements.
• Author, review and approve various validation documents including protocols, PPQ plans, final reports and process validation master plans.

The candidate is also expected to participate and network in external industry forums and conferences to influence and contribute to the evolution of cell therapy manufacturing and process validation practices. To that end, the candidate will develop a network of technical experts who understand the cell therapy manufacturing process to develop fit-for-purpose and scientifically sound process validation strategies.

The candidate may supervise a small team of 1 – 3 subject matter experts and/or contractors in support of peak execution activities.

Qualifications and Experience

• Sound scientific understanding of process validation principles
• Good understanding of the global health authority expectations around process validation
• Understanding of GMP concepts and quality systems necessary to ensure sound process validation framework
• Basic knowledge of statistics
• Good understanding of equipment/system design and validation
• Excellent communication skills, both oral and written
• Bachelor’s Degree in Life Sciences, Biotechnology, Chemical/Biochemical Engineering or equivalent field with 5+ years of experience in biopharmaceutical GMP environment. Master’s or PhD a plus.
• Validation or Cell Therapy experience, preferably in a GMP environment.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

#LI-Onsite

BMSCART

VETERAN

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.

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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.