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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 Celgene s cell therapy products. The scope will range across all cell therapy products in the portfolio, internal and external manufacturing processes/facilities for the plasmid, viral vector and drug product. This role 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 role will provide technical oversight for initial process performance qualification (PPQ) as well as throughout the product life cycle. Candidate will interface with the Site MSAT and other validation counterparts in the Celgene Biologics and small molecule network to leverage expertise and knowledge across modalities. Candidate is expected to participate and network in the external industry forums and conferences to influence and contribute to the evolution of cell therapy manufacturing and process validation practices.
The candidate will develop a network, community of technical experts who understand the cell therapy manufacturing process to develop fit for purpose and scientifically sound process validation strategies. In addition to developing strategies and standards, the candidate will participate in execution activities across the network to ensure expertise is integrated centers throughout the network and our process validation standards and master plans represent the continuous learning from the manufacturing experience.
The candidate will also contribute to the significant process validation-related investigations, troubleshooting efforts, and responses to emerging requirements or questions during health authority interactions. Candidate will 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. Candidate may supervise a small team of 1-3 subject matter experts and/or contractors in support of peak execution activities.
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
- Sound background in statistics
- Good understanding of equipment/system design and validation
- Excellent communication skills, both oral and written
Education and Experience:
- Required Bachelor s Degree in Life Sciences or Chemical Engineering
- Minimum 10 years of experience in pharma/biotech industry, min 4-6 years of validation experience in a GMP environment
- Preference will be given to candidates with Cell Therapy experience
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 gaps assessments during CMO selection and tech transfers
- Provide oversight via review and approval, as appropriate, 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, 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, as needed, various validation documents including, but not limited to, protocols, PPQ plans, final reports and process validation master plans
WORKING CONDITIONS (US Only):
- The position will work in an office environment and will need to write complex documents and final reports using a computer.
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.
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to …@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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