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. 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
This role is part of the Bothell Manufacturing Logistics & Services team and will focus supporting cGMP Manufacturing Operations for the BMS Bothell site, including the coordination, issuance, reconciliation, and management of production labels and records. Functional responsibilities include all batch label and documentation control activities for Cell Therapy Operations (CTO), including developing, performing, and maintaining a GMP compliant clinical and commercial batch documentation and label issuance and control process. The Manufacturing Labels & Issuance (MFG LI) Senior Specialist will work proactively to identify and address any batch record and label control compliance issues, own and update procedures within their functional area, and manage daily issuance activities to ensure on-time delivery.
Duties/Responsibilities
· Contributes to BMS culture and values.
· Serves as a point of contact for site functional areas regarding MFG LI tasks.
· Provides support and guidance to groups regarding label and record issuance initiatives and deliverables.
· Issuing production labels, batch records, and other controlled documents to support manufacturing operations.
· Assist Manufacturing Manager with maintaining the label issuance rooms.
· Leads process improvement projects and initiatives for the MFG LI team.
· Writes and maintains the MFG LI procedures and participates in the development and deployment of MFG LI business process tools.
· Review and approve document change requests.
· Coordinates with site scheduling regarding incoming and upcoming work.
· Solves complex technical problems; takes new perspectives using existing solutions.
· Communicate daily with Manufacturing Manager regarding team deliverables, task and project status updates, escalations, deviating events, etc.
· Role models the culture of compliance and delegates tasks as appropriate.
· Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements.
· Assist with training and onboarding MFG LI personnel.
· Supports internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during the audit. Assist with document retrieval/organization support during regulatory inspections.
· Provides daily communication to customers, management and stakeholders on the status of team deliverables.
· Issues production batch records and labels to support manufacturing operations and ensures delivery on time.
· On-call responsibilities to support business needs.
Reporting Relationship
Reports to Manufacturing Manager who oversees the MFG LI team.
Qualifications
· Extensive knowledge of SOPs and cGMPs and the know–how to work and manage within a regulatory environment.
· Demonstrates aptitude for engineering principles and manufacturing systems.
· Adaptable to a fast paced, complex, and ever-changing business environment.
· Quality Systems for Deviation, SOP revisions/creation, CAPA Management.
· Strong technical writing skill set
· Innovative, proactive, and resourceful
· Quality and continuous improvement mindset
· Ability to multitask in a fast-paced environment
· Collaborate with cross functional departments to help team deliver time sensitive projects on time
· Strong project planning skills
· Strong computer skills with MS Office (e.g. Word, Excel, and Adobe/Kofax) and with Quality Systems (e.g. Veeva Document Management System, Quality Management System)
· Strong knowledge of cGMPs
· Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)
Education
· Bachelor's degree from an accredited higher learning institution or equivalent is preferred.
· A minimum high school diploma and/or equivalent combination of education and experience is required. Experience:
· 3+ years of experience in a cGMP/FDA regulated environment and understanding of manufacturing best practices.
· Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence is highly desired.
· Current experience in document management.
SCHEDULE: Sun-Wed 11am-9pm
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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.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. 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 https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:
Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
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 a supportive culture, promoting global participation 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 an 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.
Supporting People with Disabilities
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.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
R1600376 : Senior Specialist, Manufacturing Labels & Issuance