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Associate Director, Material Review Board Process Owner, Cell Therapy

Employer
Bristol Myers Squibb Company
Location
Devens, Massachusetts
Start date
Feb 7, 2024

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Job Details

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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, theres no better place than here at BMS with our Cell Therapy team.

The Associate Director, Material Review Board Process Owner is part of the BMS Cell Therapy Quality Systems organization. At the intersection of people, process, and systems is the Business Process Owner (BPO) network. The BPO for Material Review Board works with an expanding network of internal and external stakeholders to foster cross-site collaboration, harmonize business process and deliver a road map for continuous improvement, systems implementation and help drive decision-making for initiatives associated with Quality inputs/processes related to Material Review Board (MRB) and the Out of Specification (OOS) release process.

The MRB Process Owner is positioned within the Disposition Business Process Owner team. This team is responsible for ensuring that all disposition related processes within Cell Therapy are executing compliantly, efficiently, and in a standardized fashion across the network. While this specific role is focused within the out of specification release workflow, including MRB, initiatives and projects supporting the overall disposition program are also in scope. This is an individual contributor position reporting directly to the Director, Cell Therapy Quality Disposition Process Owner.

The MRB Process Owner works closely with Cell Therapy subject matter experts, legal, regulatory, medical affairs, and IT partners. This is an exciting opportunity to shape how BMSs Cell Therapy manufacturing network operates and be part of a team influencing the overall future of the Cell Therapy network.

Key Responsibilities:

  • Serve as the CTDO Process Owner for MRB

  • Lead the MRB Community of Practice

  • Partner with franchise on internal and external communications associated with the MRB process

  • Support development of Out of Specification Release Processes for new sites, markets and/or indications within the CTDO network

  • Develop the strategy and business process road map for Cell Therapy MRB

  • Lead, develop and implement policies and procedures based on current regulations and industry standards to ensure readiness for scalability within Cell Therapy

  • Partner with cross-functional leaders to ensure compliant and scalable processes.

  • Work with senior leaders to help establish performance goals and strategic/operational objectives for MRB and OOS workflows.

  • Develop process metrics that can be used to provide performance insights to stakeholders

Qualifications & Experience:

  • Bachelor's degree in a life sciences or engineering discipline and a minimum of 7+ years of relevant biotechnology or pharmaceutical industry experience including direct experience with Quality Systems.

  • Cell Therapy experience is strongly preferred.

  • Experience participating in cross-functional matrix teams.

  • Excellent oral and written communication skills. Skilled at presenting complex topics to senior leaders.

  • Proven record leading or contributing to projects or programs in support of GXP operations

  • Experience with regulatory inspections

  • Extensive knowledge of current industry practices

  • Experience with interpretation and application of guidelines and regulations

  • Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude

#BMSCART

#HYBRID

The starting compensation for this jobin Seattle, WA is a range from $149,000-$188,000, 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 the where the job is performed.

Final, individual compensation will be decidedbased on demonstratedexperience.

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 Careers site: https://careers.bms.com

Benefitofferingsare subject to the terms and conditions of the applicable plans then in effectand may include the following: Medical, pharmacy, dental and vision care. Wellbeing supportsuch asthe 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 Years 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 doesnt 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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/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 is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

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Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
New York
New York
10016
United States

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