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Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us .

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

Position Summary

The Director of Validation, Cell Therapy Technical Operations reports to the Executive Director, Drug Product Cell Therapy Technical Operations within the Cell Therapy Development and Operations (CTDO) organization. This Technical Leadership role will provide Technical oversight to drug product and vector sites covering equipment and process validation for commercial cell therapy products manufactured globally via internal and external manufacturing sites.

This role will be serve as the Global Technical SME for Drug Product and Vector Validation. The lead will develop global technical standards for cell therapy validation and deploy the standards to site MS&T at internal and external sites. 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. Given the broad scope of validation for the expanding cell therapy global network, this role will work across the broader CTO organization to ensure alignment of key focus areas and priorities, develop strategic vision for the groups, hire and develop the leaders for the sub-function and recruit the technical talent.

The Cell Therapy Lead will cover process, equipment and supporting elements of manufacturing validation for all cell therapy products in the portfolio, internal and external manufacturing processes/facilities for the plasmid, viral vector and drug product. The person will own the accountability for the Validation function by providing oversight of all the validation activities, including providing SME assessment for proposed process life-cycle changes. The lead will serve as the Global Point of Contact for sites and will work with the sights to provide oversight and drive activities utilizing site Personnel.

This person 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 compliant with the global health authority expectations and scientifically sound.

Key Responsibilities

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

• Create, maintain, deploy global cell therapy validation technical standards via quality system.

• 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.

• Serve as global consultant for update and revision of exiting site validation master plans.

• 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.

• Ensure timely technical support for validation related questions for routine manufacturing, lifecycle process changes, quality audits and health authority inspections.

• Provide oversight via review and approval of network site level deliverables, including Validation Master Plans, process validation protocols, impact assessments and risk assessments.

• Author and review CMC summaries of validation for worldwide regulatory submissions for initialization and life-cycle changes.

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

• Facilitate cell therapy harmonization for existing manufacturing sites and adoption of industry best practices.

• Work with process development and analytical development to ensure early pipeline assets have a robust process for future validation when in pivotal trials.

Qualifications & Experience

B.S/MS.S/Ph. D in Chemical Engineering or Life Science with 12+ years of relevant experience in the biopharmaceutical company with most of that experience demonstrating progression of leadership responsibilities and scope.

Previous experience should be a combination of technical operation functions such as manufacturing, quality, MS&T or Technical Development. At least 10 years of direct experience in GMP environment is necessary.

The leader should have the ability to define the right processes for the team’s maturity level, balancing agility and discipline. Career track record and industry reputation should be competitive at the highest level among industry peers.

Leader should have demonstrated skill to lead large, complex technical organizations with global scope and build people, processes, and technology in a growing organization. In particular, recruiting and developing strong technical talent in these diverse areas of scope mentioned above will be a key consideration. Strong leadership track record especially in the areas of leading in a global and matrix environment, working cross functionally and developing strong technical talent Leader should have excellent communication skills and be able to strategically influence the direction of the company in the scope areas mentioned above. This leader will exemplify strong leadership values and be an internal and external facing ambassador of the company in the stated areas of scope in this function. Experience leading regulatory inspections regarding validation and extensive knowledge of regulations, current industry practices, and experience with interpretation and application of guidelines and regulations.

Experience with Quality Management System. Additional 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/platform

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation for this job is a range from $178,000- $224,000 (if based in Devens, MA) and $182,000-$229,000 (if based in Seattle, WA), plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS

Career Site.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1580642

Updated: 2024-05-03 04:15:14.161 UTC

Location: Summit-NJ

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.