Jobs for People with MS: National MS Society

Working with Us

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 .

Title: Associate Director, MS&T Site Lead

Location: Summit, NJ

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.

This position is part of Bristol Myers Squib (BMS) Gene Delivery Clinical cGMP Manufacturing Team, responsible for ensuring the robust execution of our internal supply for next-generation Cell & Gene Therapy assets. The individual will lead efforts to technology transfer and support the successful execution of the early phase cGMP manufacturing of Gene delivery assets to support the BMS Cell Therapy portfolio. He/she will establish interrelationships between process development, manufacturing, quality, and regulatory aspects of Gene Delivery development and how it pertains to overall business strategy. In particular, he/she will apply that understanding to drive cross-functional improvements to support the successful design, and tech transfers of new modalities into the clinical cGMP manufacturing facility at BMS. In addition, the individual will be a core member of the CMC teams for early-stage programs, leading efforts to ensure the successful transfer, scale-up, facility fit, and execution of Gene delivery material supply.

The Associate Director of Manufacturing, Science, and Technology at the S6A Clinical Manufacturing site leads a team responsible for supporting the production of Gene Delivery/ Editing assets for clinical trials. Oversees the technical manufacturing support, new product introduction, technology transfer, and lifecycle management of clinical programs. Provides technical, compliance, and continuous improvement support to the production operations to ensure rapid, flawless, and cost-effective delivery of quality products.

The individual will manage and execute multiple parallel projects aligned with department goals. Plans project(s) objectives and priorities. Manages multiple tasks efficiently and resolves competing priorities. Establishes timelines, and goals for tech transfer tools and drives efficiency. The individual will be part of the Clinical Manufacturing leadership team overseeing a group of technical teams and support. He/ she will also have experience with equipment selection, with support of equipment qualification activities. BMS evolving Gene- therapy teams will allow for high throughput, highly productive cGMP manufacturing operations fueling a fast-paced environment. This position offers an experienced individual a significant opportunity to establish best practices for technical support of cGMP manufacturing operations and help expand the group to enable new technology execution.

Responsibilities

Ensure safe and compliant cGMP operations.

• Interface with regulatory authorities as required to support Manufacturing Operations audits.

• Foster a culture of compliance and strong environmental, health, and safety performance.

• Own technical and compliance risk assessments.

• Liaise with teams both within CTDO and outside the network (gMSAT, external vendors, supplier quality, etc.) to ensure all materials, equipment, and processes are compliant.

Support the Senior Director in developing productivity with the cross-functional team.

• Implement metrics to track and manage the completion of objectives and projects.

• Monitor the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management.

• Drive strong collaboration within the operation teams and across the network.

• Cascade organizational strategic goals and objectives that are linked to the overall company strategy.

• Deliver business results through timely and quality decision-making and advice.

• Participate in the above site activities that pertain to scale-up, product accelerations, lessons learned, etc.

Support Clinical Production Activities.

• Continuously monitor, anticipate, and permanently resolve issues that may arise during production.

• Support investigations, ensuring compliance with internal standards and regulatory requirements.

• Monitor plant performance metrics and support plant operating review meetings.

• Support the life cycle management of each clinical program, including execution of change controls and managing all activities.

• Lead facility fit, the introduction of new products, including the technical transfer, and S6A manufacturing readiness activities.

• Develop tools and templates for the tech transfer activities to facilitate accelerations.

• Lead clinical investigations of all manufacturing operations root cause investigations, CAPAs, and Change Controls.

Lead Site MSAT Team.

• Ensure employees have the resources needed to meet or exceed their goals; ensure adequate systems, procedures, personnel, and equipment are in place.

• Stay current with industry trends and standards and participate in best practice forums consistent with function responsibilities.

• Select and develop a well-trained, motivated, and informed staff.

• Build trust and effective relationships with peers and stakeholders.

• Create an environment of teamwork, open communication, and a sense of urgency.

Qualifications & Experience

• Chemical engineer, Biochemical engineer, or Biochemistry background. Ph.D. with 8+ years of relevant experience or MS/BS with 12+ years of experience in a pharmaceutical or biotechnology company.

• Experience in biologics or viral vector process development and cGMP manufacturing of biologic or viral vector products.

• Experience implementing biotechnology unit operations including fermentation and/or mammalian cell culture, chromatography, tangential flow filtration, virus, and bioburden reduction filtration.

• Knowledge of cGMPs, biopharmaceutical/cell therapy regulations, and experience providing technical support in a cGMP manufacturing environment in a low bioburden facility. Knowledge of GMP sterile manufacturing is a plus.

• Advanced expertise in scale-up and process transfer for either cell culture/fermentation unit operations or protein/nucleic acid purification unit operations.

• Advanced hands-on experience with single-use technologies, and closed systems.

• Advanced knowledge of facility/clean room design, process, equipment, automation, and equipment validation

• Advanced knowledge of Quality Risk Management and risk assessment methodologies.

• Experience in managing technical or operation teams.

• Advanced abilities to effectively manage cross-functional teams throughout projects.

• Advanced technical writing skills, and strong verbal skills, and ability to influence at all levels.

• Ability to think strategically and to translate strategy into actions.

• Ability to prioritize and provide clear direction to team members in a highly dynamic environment.

• Embrace change and build an adaptive team mindset.

• Knowledge of data management tools and statistical process control

• Experience with operating and troubleshooting process equipment.

• Experience working on late-phase and commercial programs is a plus.

• Experience with Operational Excellence and Lean Manufacturing is a plus.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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.

#LI-Onsite

BMSCART

VETERAN

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/ 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: R1582161

Updated: 2024-06-29 04:19:35.183 UTC

Location: Summit West-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.