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Bristol Myers Squibb: Sr. Director, Global Validation And Tech Services – Cell Therapy

Bristol Myers Squibb

This is a Full-time position in Seattle, WA posted December 27, 2020.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science.

In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change.

We bring a human touch to every treatment we pioneer.

Join us and make a difference.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today.

With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

Come and join Celgene for this key leadership role to be part of the team building a leading CAR T Platform that serves our patients with novel Celgene CAR T Therapies.

At BMS, 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.

This role will report to the Vice President of Cell Therapy Global Manufacturing Science and Technology and is a key leadership role within BMS Cell Therapy Development and Operations (CTDO) Division.

Reporting to this role will be team leaders/SMEs responsible for various sub-functions such as gene delivery/editing validation, drug product process engineering, packaging and shipping validation, labeling and global automation.

Role will also have a dotted line oversight of validation activities managed by the site MSAT validation leads across cell therapy manufacturing network to ensure harmonized approach.

This senior leadership role will lead validation programs across the entire manufacturing network in CTDO (Cell Therapy Development and Operations) covering process, equipment and various supporting elements of manufacturing validation.

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.

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 and ensuring that these standards are reflected in the quality system.

The equipment validation responsibilities include developing validation standards, framework for harmonized validation strategies for similar equipment and unit operations across plants and IQ and OQ activities during the commissioning stages of new equipment.

This team will also support validation activities needed during design and build of new manufacturing plants 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 local 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, this leader will interface with the validation counterparts in the BMS 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 head 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.

The scope of this group also includes packaging, shipping validation and commercial labeling for late stage clinical programs, launch and commercial operation.

This head will also establish global automation function the scope of which will evolve as we commercialize our first CAR T products.

This scope will include development of automation lifecycle guidance standards and policy, establishing data gathering systems and repositories across sites and products, leading and contribute to projects focused on the design, development, and qualification of automated processes, equipment, and systems into GMP manufacturing Job Description: Major job duties include: 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 cell therapy 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 CAPAs and audit findings Develop/approve cGMP documents including, but not limited to, Master Validation Plans, protocols.

Collaborate with QA 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 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 Lead global 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 Provide oversight via review and approval of network 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 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 Expand automation lifecycle to enable phase appropriate implementation, realizing benefits of technologies in manufacturing network 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 experience with Quality Management System (e.G.

Deviations, CAPAs, Change Management) 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 quality.

Experience with manufacturing automation systems/platforms If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team.

Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science.

From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine.

Join us today.

BMSCART 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.