Principal Engineer Sterility Assurance Cell Therapy

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Reporting to the Head of Cell Therapy Global Validation within Global Manufacturing Science and Technology (GMSAT), this is a key senior level role that will define and implement the aseptic process validation and sterility framework for Bristol Myers Squibb’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 compliance to aseptic processing during manufacturing, defining sterile boundary, related testing and filter validation studies 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 level and other sterility assurance counterparts in the Bristol Myers Squibb Biologics and broader 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 aseptic processing 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 aseptic processing 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 aseptic standards and master plans represent the continuous learning from the manufacturing experience. The candidate will also contribute to the significant aseptic validation issues, investigation efforts and responses to emerging requirements or questions during health authority interactions. Candidate may supervise a small team of 1-3 subject matter experts and/or contractors in support of peak execution activities.

Responsibilities will include, but are not limited to the following:

Develop and implement aseptic processing policies to define robust compliance within the cell therapy product lifecycle.

Define aseptic processing, microbial testing and filter validation strategies for upcoming products and support PPQ execution in a multi-site commercial environment.

Assist other GMSAT and Site MSAT teams with implementation of this strategy

Author CMC content for regulatory filings and participate in formal agency meetings.

Develop and implement continuous process monitoring strategies and ensure aseptic status throughout commercial lifecycle

Respond to site independent aseptic processing troubleshooting issues, questions

Coordinate responses to health authority questions on aseptic processing that require a coordinated response or implementation across cell therapy manufacturing.

Author, review and approve, as needed, various validation documents including, but not limited to, protocols and technical standards

Establish and lead the cell therapy aseptic validation best practice forum

Up to 25% travel between various Bristol Myers Squibb/legacy Celgene sites to ensure validation standard implementation

Skill and Knowledge Requirements:

Required Bachelor’s Degree in Life Sciences or Chemical Engineering

Minimum 10 years of experience in pharma/biotech industry, min 3-5 years of aseptic cell therapy/sterile processing experience in a GMP environment

Preferred but not required:

Cell therapy specific experience (MSAT or technical operations)

Knowledge/experience of analytical methods relevant for microbial control

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com