Director Product Technical Stewards 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's Cell Therapy Division to be part of the team building a leading cell and gene therapy portfolio that serves our patients with novel engineered T-cells. We are developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer. Cell Therapy Global Manufacturing Science and Technology (GMSAT) plays a critical role in establishing a commercial manufacturing process, Technology Transfers, product life cycle management, process and equipment validation, technical oversight of external manufacturing partners and enable a robust and scaleable, global cell therapy manufacturing network. This role will report to the Vice President of Cell Therapy, Global Manufacturing Science and Technology (GMSAT) and is a key leadership role within Bristol Myers Squibb's Cell Therapy Development and Operations (CTDO) Division as we get ready to commercialize autologous cellular biologics to overcome tumor evasion and potentially eradicate cancer cells.

This role will lead a global team of product technical stewards and process engineers in global Manufacturing, Science and Technology. Technical Product Stewards are very experienced engineers/scientists (typically at the level of Director, Principal/Senior Principal Bioengineer) who serve as the single point of contacts to the CMC and TCT teams to manage the life cycle of the cell therapy manufacturing process. The steward role is identified early in the product development lifecycle (no later than pivotal clinical phase) to enable a “line of sight” to commercialization and typically stays with the program through launch and beyond supporting post-approval life cycle management. The Director of stewards provides strategic and technical direction to the group of technical stewards across all cell therapy programs to ensure commercial manufacturing requirements are built into product development and launch strategies. This includes harmonization of the manufacturing process platform across products and manufacturing sites. The Director will oversee this team that is responsible specifically for developing product specific validation master plans, process qualification, process control and comparability strategies, authoring technical sections of major regulatory documents and contributing to the overall CMC and commercial strategy. With a keen technical understanding of the cell therapy manufacturing process and product control strategies, this role is expected to develop a roadmap for how cell therapy manufacturing platforms should evolve across multiple products and influence the efforts of the technical development group based on a vision for the longer term manufacturing process, while supporting aggressive launch timelines. The role will also help balance the life cycle management priorities across products so that we focus our energy on the most impactful LCM projects. The director will be a close partner to the CMC management function and other MS&T functions to help align product lifecycle plans with network lifecycle plans. Successful candidate will also influence the CMC and regulatory strategies for global product approvals. The director is expected to seamlessly float across programs to guide the individual technical stewards while deep diving into specific programs based on the complexity of emerging issues. The technical stewards for the viral vector process will report solid line to the Vector MS&T team but will have a dotted line connection to this head to ensure alignment of technical strategies where needed.

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

Develop systems, tools and framework to manage and share cellular product / process knowledge across the clinical and commercial product lifecycles.

Develop/maintain a set of commercial manufacturing requirements and ensure those are integrated into the development efforts in a phase appropriate manner.

Accountable to ensure that the technical stewards deliver the CMC/TCT team deliverables assigned.

Review/approve the product specific documents, technical reports, dossier sections authored by the respective stewards.

Collaborate with CMC functions (Regulatory, Technical Development, Product Quality, Supply Chain, Manufacturing, etc) to develop comprehensive and prioritized product lifecycle (LCM) plans and provide prioritized plans to the various global and site MS&T teams to enable execution by those functions.

Harmonize commercial manufacturing control strategies across products and sites

Help develop framework and templates for key technical deliverables such as process control strategy, product master validation plan and PPQ

Work in a matrix environment with the Vector MS&T, drug product MS&T, global validation and clinical MS&T groups to provided technical support on tech transfers, process validation, technical reports, data analysis, process monitoring, change control, product comparability and resolution of unplanned issues that require product specific expertise

Collaborate with Technical Development groups on lifecycle improvements.

Provide technical content for key documents such as PPQ or comparability assessments, author regulatory submissions, present technical strategies during health authority interactions and inspections.

Function as a subject matter expert for autologous T cell therapies and manufacturing technologies.

Provide technical input and requirements for design of future manufacturing facilities.

Serve as a mentor to staff in the technical teams.

Present complex technical topics internally and externally.

Most importantly, develop and mentor the staff to be effective product technical stewards who are seen as thought leaders and deep technical experts by the CMC/TCT teams and other MS&T functions

Represent global MS&T into various cross-functional meetings or governance bodies as appropriate.

Ideal candidate will work very closely with counterparts in cell therapy process and analytical development, regulatory, quality, MS&T network functions and manufacturing sites.

Basic Qualifications

B.S., M.S. or Ph.D in Engineering or life science with 10-15 years of relevant technical experience in technical development, manufacturing science or other disciplines in technical operations.

Strong understanding of cell therapy process development and manufacturing

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 processes in a regulated environment.

Experience in technical supervision, coaching and mentoring technical teams.

Strong interpersonal skills with evidence of building good relationships with cross functional team members and partner groups.

Experience in product/process CMC life cycle management including pre-approval, launch and post-approval stages.

Strong analytical, problem-solving, and critical thinking skills.

Sound experience of data handling and applied statistics.

Experience with Quality Management System (e.g. Deviations, Corrective and Preventative Actions (CAPAs), Change Management)

Preferred Qualifications:

Candidate has majority of the experience concentrated in cell therapy.

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