Senior Process Engineer 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.

Come and join Bristol Myers Squibb for this key role to be part of the team building a leading CAR T Platform that serves our patients with novel Cell Therapies. Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer.

This position provides technical and process leadership of the cell therapy manufacturing process from pivotal to post-approval stages. This is a key technical role within Bristol Myers Squibb's cell therapy technical operations division as we get ready to commercialize autologous cellular biologics to overcome tumor evasion and potentially eradicate cancer cells. This role will assume technical leadership of process changes related to the life-cycle management of a commercial CAR T Therapy. This includes establishing the requirements for the manufacturing process, coordinating technical transfers to manufacturing and between sites, developing process qualification, process control and comparability strategies, authoring technical sections of major regulatory documents and contributing to the overall CMC and commercial strategy.

The scope of the role includes providing ongoing technical oversight to manufacturing, defining and driving a long-term process improvement lifecycle plan and ensuring successful execution of the technical strategy. The role will work cross-functionally across technical operations and most closely with process and analytical development, quality, regulatory, manufacturing and supply chain counterparts. The incumbent will help drive the validation, qualification and comparability strategies and be viewed as a subject matter expert internally and externally in cell therapy drug product manufacturing technology.

The roles and responsibilities include, but are not limited to, the following:


Play a key role in development of commercial lifecycle plan for a cellular product, maintain oversight of process capability through data trending and statistical analysis of critical variables, ensure processes are robust, in a continued state of validation, and continuously improving.
Develop product technical strategies including manufacturing requirements, process improvement plans, post approval life cycle management plans and ensure successful and timely execution working across functional groups.
Provide support on strategic initiatives including tech transfers, process validation, technical reports, data analysis, process monitoring, change control, product comparability and second line support of technical/scientific process and analytical issues.
Collaborate with Technical Development, manufacturing sciences and technology and manufacturing operations groups on lifecycle improvements.
Provide technical content for significant documents such as PPQ or comparability assessments, author content for regulatory submissions, present technical strategies during major health authority interactions and inspections.
Perform and support data monitoring of manufacturing processes to understand process capability and to increase robustness and sustainability.
Function as a subject matter expert for autologous T cell therapies and manufacturing technologies.
Provide technical input and requirements for design of future clinical and commercial manufacturing facilities.
Present complex technical topics internally and externally.


Basic Qualifications


B.S., in Engineering or life science with >6 years of relevant technical experience in technical development, manufacturing science or other disciplines in technical operations - OR
MS and 4 years
PhD and 2 years
Strong understanding of bioprocess unit operations, especially cell culture.
Excellent written and verbal communication skills. Ability to convey complex technical issues to diverse audiences including internal teams, external partners, and health authorities.
Demonstrated experience developing and/or transferring drug products within a pharmaceutical environment.
Proficient in project management and team leadership skills, with a thorough understanding of critical unit operations involved in drug product manufacturing.
Experience in technical supervision, coaching and mentoring or leading small matrixed teams of people or scientific projects.
Evidence of strong communication skills and of building good relationships with cross functional team members and customers.
Established scientific professional with track record of technical and cultural leadership and globally-recognized accomplishments that include advancing projects. Influences site and global strategy. Visible contributions to external scientific community, including regulatory settings.
Experience in product/process CMC life cycle management including pre-approval, launch and post-approval stages.
Strong analytical, problem-solving, and critical thinking skills, Corrective and Preventative Actions (CAPAs), Change Management)


Preferred Qualifications:


Previous experience in managing technical interactions with Contract Manufacturing Organizations, manufacturing of cell therapies, or product life cycle management is highly desirable


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.

Company: Bristol-Myers Squibb

Req Number: R1525697_EN

Updated: 2020-05-26 00:00:00.000 UTC

Location: Summit,New Jersey

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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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