Technical Fellow Cell Therapy Validation

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 leadership role to be part of the team building a leading Cell Therapy Platform that serves our patients with novel Bristol Myers Squibb Cell Therapies. At Bristol Myers Squibb, 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. The Seattle Validation Lead role will report to the Senior Director of Cell Therapy Global Validation in the Global Manufacturing Sciences and Technology group (GMSAT). The Director, Validation Lead, Cell Therapy is a key leadership role within Bristol Myers Squibb’s Cell Therapy Development and Operations (CTDO) Division. Reporting to this role will be 2-3 validation process engineers and subject matter experts.

This senior leadership role will lead validation programs across the entire Seattle manufacturing network in Cell Therapy Development and Operations (CTDO) covering process, equipment and various supporting elements of manufacturing validation. The scope will range across all cell therapy products in the Seattle/JuMP portfolio, internal and external manufacturing processes/facilities for the plasmid, viral vector and drug product. The process responsibilities include 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.

This team will also support validation activities needed during design and build of new/modification of JuMP manufacturing plant to make sure the engineering approaches consider our harmonized validation framework that is complaint with the global health authority expectations and scientifically sound. This leader is expected to work across various CTDO functions, internal and external manufacturing sites and collaborate closely with Site Manufacturing, Science and Technology (MSAT) validation groups, quality and regulatory functions to shape the process, equipment and validation program and policies that are harmonized and defendable with the global health authorities.

Furthermore, the validation lead will interface with the validation counterparts in the Bristol-Myers Squibb 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 validation practices. The lead will develop a team of technical experts who understand the cell therapy manufacturing process to develop fit for purpose and scientifically sound validation strategies. In addition to developing strategies and standards, the team will participate in execution activities across the network to ensure expertise is integrated within the different work centers and our validation standards and master plans represent the continuous learning from the manufacturing experience.

Job Description:

Primary Responsibilities:


Lead, develop and implement scientifically sound and fit for purpose validation standards and procedures based on current regulations, industry standards and industry practices for cell therapy.

Promote innovative and efficient approaches to validation incorporating risk-based elements and considerations unique to cell therapy production.

Lead, develop and implement the master validation plans for process, equipment and facilities, in collaboration with the validation and technical SME network.

Develop and guide process validation, qualification and process monitoring strategies and framework.

Guide the teams to storyboard and present our global validation framework, standards and approaches during major health authority inspections.

Shape and review the technical content in the validation sections of the dossier

Support Quality and IT for validation of computer systems, as needed

Provide validation expertise for issue resolutions to support deviations or Corrective and Preventative Actions (CAPAs) and audit findings

Develop/approve current Good Manufacturing Practices (cGMP) documents including, but not limited to, Validation Master Plans, process validation protocols and risk assessments.

Collaborate with Quality Assurance to monitor and respond to audit observations related to GXP regulations

Work with MSAT network, to assess impact of changes to facility/processes validated state

Lead site validation team providing oversight of internal programs and with direct responsibility for validation activities at contract manufacturing organizations, including validation gaps assessments during CMO selection and tech transfers

Design qualification strategies to support novel applications of fill, filtration, sterilization and single-use disposable technologies

Facilitate harmonization amongst sites and adoption of industry best practices

Partner with Quality Assurance to maintain high standard of compliance in all program deliverables.

Work closely with process and analytical development and MSAT network during process characterization and validation stages of the late stage development to ensure that the process validation framework is consistent with our overall strategy

Mentor a team of validation engineers and professionals and enable their individual growth

Establish performance goals and strategic/operational objectives for direct reports

Track department performance metrics and provide progress reports to stakeholders


Basic Qualifications:


Bachelor's degree in a Life Sciences or Chemical Engineering discipline and a minimum of 15 years of relevant biotechnology or pharmaceutical industry (operations, technical development, MSAT)

10 years of direct experience in GMP validation activities, and 7 years of people management

Proven record with successfully managing validation programs in support of GMP operations

Experience leading regulatory inspections regarding validation

Extensive knowledge of regulations, current industry practices, and experience with interpretation and application of guidelines and regulations

Strong leadership track record especially in the areas of leading in a global and matrix environment, working cross functionally and developing strong technical talent

Excellent written and verbal communication skills at all levels in the organization


Preferred Qualifications:


2-3 years of experience in cell therapy process development and or manufacturing.

Combination of experience in process development, MSAT and validation.


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

Sign Up Now - PharmaceuticalCrossing.com