Specialist, MSAT Cell Therapy Engineering Support, Investigations
Engineering
Full Time
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 .
Position Summary:
The primary focuses of the MSAT CTES Specialist are to complete deviation investigations and provide product and process support to Cell Therapy Manufacturing Operations at Bristol Myers Squibb's GMP facility in Bothell, WA. The MSAT CTES Specialist:
General:
Education:
The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decid ed based on demonstrated experience.
For more on benefits, please visit our BMS Careers si te.
Eligibility for specific benefits listed in our careers site may vary based on the job and location.
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.
TRAVEL REQUIREMENTS:
☐ Not Applicable-NA
Infrequent visits to other BMS Cell Therapy sites and the Seattle, WA facility may be required.
WORKING CONDITIONS (US Only):
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 within reason.
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.
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 primary focuses of the MSAT CTES Specialist are to complete deviation investigations and provide product and process support to Cell Therapy Manufacturing Operations at Bristol Myers Squibb's GMP facility in Bothell, WA. The MSAT CTES Specialist:
- Is a process and product expert
- Works with applicable SMEs to determine immediate corrections for manufacturing events
- Performs product impacting root cause investigations and identification of corrective actions
- Works within the GMP Quality Systems to deliver MSAT initiatives
- Leads/supports process improvement and lean initiatives to support productivity gains
- Makes data driven decisions and recommendations
- Represents MSAT on cross-functional and cross-site project teams
General:
- Function as a technology, product, and process subject matter expert; may serve as system SME on one or more manufacturing unit operations or families of equipment
- Provide off hours on-the-floor and on-site/remote troubleshooting and technical support
- Facilitate deviation prevention and deviation closure through site quality systems
- Analyze and summarize manufacturing data to support impact assessments and investigations
- Support site risk assessment program and may own MSAT related risk assessment documentation, as applicable
- May execute trending of commercial production data to drive actions for manufacturing process improvement
- Support use of continuous improvement/lean tools to identify opportunities for process improvements and operational efficiencies, and may lead projects to implement
- Represent MSAT when interfacing with other local and global functional teams
- Actively manage deviations to achieve RFT (Right First Time) and on-time phase completion, including deviation closure by the original due date
- Assess, investigate and close Phase II Manufacturing Investigations of drug product out of specification events in coordination with technical reviewer and Quality reviewer / approver
- Immediately upon assignment of an investigation, partner with their investigations team (QA Reviewer/Approver, SME(s) as applicable, and necessary stakeholders) on definition and alignment of the investigation plan, required data, and timing for completion
- Continue to partner with investigation team throughout the investigation process to ensure agreement / alignment on root cause and CAPA
- When CAPA are needed, facilitate the investigation/CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements
- Ensure smooth transition of the defined CAPA to the owning department SME and ensures the CAPA progresses to implementation timely to ensure on-time deviation closure
Education:
- BS in Biology/Chemistry Science/Engineering or related field
- Certificate or Masters in Immunology (preferred)
- 2+ years of relevant cGMP experience, or 0 years relevant cGMP experience with MS
- 1+ years working within quality systems managing deviation and CAPA records
- Biologics, small molecule, vaccine, or cell therapy manufacturing
- Lean/six sigma
- MS Office Applications
- Deviation writing
- Familiarity with the Quality Management System
- Excellence in written and verbal communication
- Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects
- Strong scientific and technical acumen including superior technical writing skills
- Excellent problem-solving skills, including issue resolution, root cause investigations
- Able to apply engineering principles and statistical analysis to resolve processing issues and evaluate process improvement opportunities
- Innovative, proactive, and resourceful; committed to quality and continuous improvement
- Trained in Kepner Tregoe Problem Solving
The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decid ed based on demonstrated experience.
For more on benefits, please visit our BMS Careers si te.
Eligibility for specific benefits listed in our careers site may vary based on the job and location.
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.
TRAVEL REQUIREMENTS:
☐ Not Applicable-NA
Infrequent visits to other BMS Cell Therapy sites and the Seattle, WA facility may be required.
WORKING CONDITIONS (US Only):
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 within reason.
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.