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Senior Manager, MSAT Investigations and Compliance Programs, Cell Therapy Engineering & Support

Company: Bristol-Myers Squibb
Location: Bothell
Posted on: January 27, 2023

Job Description:

Working with UsChallenging. 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: PURPOSE AND SCOPE OF POSITION:The Senior Manager MSAT Investigations & Compliance Programs at the Juno Manufacturing Plant's (JuMP) in Bothell, WA is accountable for supporting management of manufacturing site investigations and associated actions by providing clear visibility with respect to timelines, resources, and prioritization. Their mission is to improve deviation and investigation closure rates by monitoring team performance and productivity, driving process improvements, enabling clear prioritization of actions, and identifying and systematically removing roadblocks. The Senior Manager will work cross-functionally within site and across the BMS network to enable success for the MSAT investigations team.This position is at the Bothell, WA BMS manufacturing facility. A minimum 50% onsite work is required. Minimal travel to other BMS sites both in and outside of WA will be required.REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:Education:Bachelor of Science degree, Biochemistry, Chemical Engineering, Biology or other relevant science discipline or 5 years of experience troubleshooting within a manufacturing environment in lieu of a bachelor's degree.Experience:Basic Qualifications:

  • 5-10 years of manufacturing or quality experience, preferably within biopharma, cell therapy, GMP, FDA regulated, or other regulated environments
  • Proficient in MS Office applications
  • Proven experience as a Project Manager including use of Project Management software, preferably Smartsheet
  • Utilize data and key performance indicators to drive process improvement
  • Lean / Six Sigma training and/or experience with these tools and methodology
  • Trained in multiple methods of root cause analysis and capable of facilitation
  • Strong knowledge of GMP compliance, regulations and manufacturing operations
  • Experience driving projects and actions in a cross functional environment with timely and effective communications and a sense of urgency to achieve immediate and future goals
  • Ability to drive organizational change to improve business performance
  • Ability to work in a fast-paced environment and manage multiple projects and objectives in parallel.
  • Must be proactive, action oriented, and have the ability to adapt to a change.
  • Must be able to identify risks in a timely manner to keep deliverables on track.
  • Must have excellent communication skills both verbally and written.
  • Proven logic and decision-making abilities, critical thinking skills. Must have a questioning attitude, and the ability to utilize information to make the best decision for the department.Preferred Qualifications:
    • Experience with cell therapies highly desired
    • Experience working in a manufacturing or engineering capacity highly desiredDUTIES AND RESPONSIBILITIES:
      • Provide support to a team of deviation investigators / supervisors to ensure compliant and timely completion of deviation investigations to meet quality, safety, and lot release site deliverables.
      • Monitor team workload and develop leading KPI's to drive continuous improvement w.r.t. deviation triage, investigation, and follow up actions.
      • Responsible for monitoring resource availability and prioritization for investigation activities.
      • Accountable for implementing resource model predictions, and reporting of departmental metrics to the leadership team.
      • Conduct regular performance metric reviews and support way of working adjustments to improve team efficiency.
      • Demonstrate expertise in project management and have an in-depth understanding of manufacturing & quality systems to continue to build and deploy the most efficient business processes.
      • Ability to coordinate multiple departments and cross functional activities through strong meeting facilitation, conflict resolution, real-time troubleshooting, and prompt decision making.
      • Develop and manage detailed project schedules. Coordinate and track execution of project plan activities and action items to ensure that deliverables are completed on time and in alignment with Quality standards.
      • Prepare and deliver presentations and project/program status updates to team members, leaders, and other stakeholders to ensure ongoing visibility to project/program plans, status, decisions, risks, and issues.
      • Leverage site and global resources to identify the activities needed to produce deliverables.
      • Act as a learning resource for new team members given proficiency in technical writing.
      • Champion of quality, safety, and compliance culture; demonstrate critical thinking skills and high reliability mentality, ensure work is completed according to cGMP guidelines and BMS procedures.The starting compensation for this job is a range from $114,000 - $144,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience. For more on benefits, please visit our BMS Careers site. Eligibility for specific benefits listed in our careers site may vary based on the job and location.WORKING CONDITIONS (US Only):Employee will work in typical office conditions (sit/stand desk, lighting, temperature, noise-level, office equipment and air quality) with occasional work in the manufacturing cleanroom for specific tasks. Ability to lift a desired weight is not neededThis 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.BMSCART VETERANIf 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 CareersWith 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 ProtocolPhysical 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.COVID-19 InformationTo protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.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.

Keywords: Bristol-Myers Squibb, Seattle , Senior Manager, MSAT Investigations and Compliance Programs, Cell Therapy Engineering & Support, Healthcare , Bothell, Washington

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