Senior Manager, Global MSAT Process Validation Engineer
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
PURPOSE AND SCOPE OF POSITION:
Reporting to the Head of Cell Therapy Global Process Validation within Global Manufacturing Science and Technology, this is a key role that will define and implement the process validation framework for our cell therapy products. The scope will range across all cell therapy products in the portfolio, internal and external manufacturing processes/facilities.
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.
In addition to developing strategies and standards, the candidate will also
- 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 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.
DUTIES AND RESPONSIBILITIES:
- 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, 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, but not limited to, protocols, PPQ plans, final reports and process validation master plans.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- 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
Education and Experience:
- Minimum Requirements: Bachelor’s Degree in Life Sciences or Chemical Engineering with 8 years of experience in pharma/biotech industry and a minimum of 4 years of validation experience in a GMP environment
- MS or PhD not required but would be a plus
- Preference will be given to candidates with Cell Therapy experience
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
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