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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