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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 .

Position Summary:

The Director, Quality Disposition Operations will be responsible for the development, implementation and sustainability of the processes for disposition of incoming materials and commercial final drug product for the Devens Cell Therapy Facility (CTF). This role is responsible for the day-to-day evaluation of product quality and disposition of the products produced at the Devens CTF. This person will be a key leader for the Devens CTDO Quality team, a member of the Quality Leadership team, and a champion for quality principles and compliance within the Devens organization. While this position will lead a team of Quality professionals responsible for product disposition, this position will from time to time be required to perform the lot disposition process for batches produced at the Devens CTF. Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Devens. This role will work with Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, and MS&T.

This role is stationed in Devens, MA and reports to the Executive Director, Quality for the Devens Cell Therapy Facility.

Key Responsibilities

• Experience with implementing and overseeing GMP operations in a plant manufacturing both clinical and commercial products is required.

• Background in Protein Biologics or Cell Therapy Manufacturing is strongly preferred.

• Demonstrated experience building and leading exceptional teams is required.

• Ability to effectively lead a team, drive accountability, and prioritize deliverables.

• Experience leading in a dynamic, collaborative, and fast paced environment.

• Understanding of financial principles, core business concepts, and business management.

Qualifications & Experience

• BS/MS in relevant Science or Engineering discipline and 10+ years of experience in managing Quality Assurance or Manufacturing function; at minimum 7 years of people management experience.

• Expertise in GMP compliance and FDA/EMA regulations.

• Develop and continuously improve processes to ensure timely product disposition; manage the disposition activities for clinical and commercial finished drug products by ensuring all relevant documentation associated with a lot are accounted for, completed and approved by the appropriate individuals.

• Develop and continuously improve processes for the review and approval of the QC documentation related to each lot (Certificate of Analysis and QC testing data, including EM and analytical data).

• Develop and continuously improve processes for the review and disposition raw and intermediate materials used in the manufacture of drug products.

• Collaborate with stakeholders and management and communicate batch disposition status; monitor progress and issue status reports.

• Develop and continuously improve the procedures and processes for the performance of the review of lot genealogy for all raw materials and components used in each lot to ensure they are approved and released using the electronic system (MES - Manufacturing Execution System).

• Develop and continuously improve the procedures and processes for SAP and MES Master Data.

• Lead the site Material Review Board (MRB) meetings and evaluate recommendations made by the board during product disposition.

• Develop, own, and maintain SAP Quality Module, including procedural document and training for Quality staff.

• Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of implemented cGMP policies and quality management system.

• Contribute to the development and execution of the Pre-Licensing Inspection (PLI) and commercialization readiness plan at the Devens CTF.

• Develop departmental goals and ensure the timely completion of all deliverables.

• Champion and foster a positive and successful quality culture.

• Mentor Quality personnel and enable their individual growth.

• Act as subject matter expert for QA oversight of cGMP operations during audits and regulatory inspections.

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: R1582980

Updated: 2024-07-01 04:14:08.077 UTC

Location: Devens-MA

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.