Principal Scientist, Flow Cytometry, Analytical Sciences & Technology (CTQ)
Company: Disability Solutions
Location: Seattle
Posted on: November 2, 2024
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:
.Position Summary: BMS is seeking a Principal Scientist for the
Cellular Therapies Development and Operations (CTDO) organization
who will be responsible for the Quality oversight of Flow Cytometry
in support of the Cellular Therapy product portfolio. This position
will report into the Analytical Science & Technology group.
Successful candidates will have a strong foundation in flow
cytometry methods as well as a demonstrated experience working in a
cGMP environment. Responsibilities:
- Responsible for the life-cycle management of commercial flow
cytometry methods in the Quality organization.
- Responsible for transfer and validation of methods in the
commercial environment in compliance with global regulatory
requirements.
- Implement method lifecycle and method maintenance programs to
support flow cytometry methods used in the release cell therapy
drug products.
- Responsible for authoring relevant analytical sections of
submissions, responding to health authority questions and
representing the QC function during inspections.
- Function as the flow cytometry technical expert for QC labs
during internal QC investigations and as the Quality liaison with
contract test labs during QC investigations.
- Partner with development organizations in the design of
development and qualification studies, selection and
characterization of critical reagents, and method optimization
initiatives. Represent the commercial QC function on
cross-functional project development teams.Qualifications &
Experience:
- BS/MS in relevant scientific discipline and 10+ years
experience designing and leading flow cytometry method validations
and method transfers is required. Experience in cellular therapies
is preferred.
- Strong scientific background and expertise with a range of flow
cytometry platforms from analyzers to cell sorters, multi-parameter
flow cytometry methods and antibody titration and qualification
procedures is required. Experience with spectral flow cytometry,
auto-gating algorithms and implementation of automated platforms is
highly desired.
- Must be able to function independently as lead investigator and
lead analytical investigations.
- Experience with implementing flow cytometry methods in a
commercial QC facility is required. Demonstrated experience in
method lifecycle management in a commercial environment is desired.
Experience training QC analysts in method execution and instrument
operation and strong technical writing experience (SOPs, Method
Validation Protocols and Reports) is required.
- Experience in cGMP regulations and application within the
Quality Control environment. Understanding of FDA, EMA, ICH, USP,
and EP guidelines and regulations associated with the quality
control of biological products is required.
- Must possess effective time management skills, demonstrate
initiative, resourcefulness and flexibility to work independently
and as part of a team. Strong technical writing experience (SOPs,
Method Validation Protocols and Reports) is
required.#BMSCART#HYBRIDThe starting compensation for this job in
Seattle, WA is a range from $127,000-$159,000 , plus incentive cash
and stock opportunities (based on eligibility). The starting pay
rate takes into account characteristics of the job, such as
required skills and where the job is performed. 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 .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. 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 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 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 . Visit 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.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: Any data processed in connection with role
applications will be treated in accordance with applicable data
privacy policies and regulations.
Keywords: Disability Solutions, Bellevue , Principal Scientist, Flow Cytometry, Analytical Sciences & Technology (CTQ), IT / Software / Systems , Seattle, Washington
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