Sr. Manager / Associate Director, Global Sterility Assurance CTTO
Company: Disability Solutions
Location: Seattle
Posted on: October 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: .Title:
Sr. Manager / Associate Director, Global Sterility Assurance
CTTOLocation: Seattle, WA, Devens, MA or Summit, NJAt Bristol Myers
Squibb we are reimagining the future of cell therapy . With our
bold ambition, backed by a best-in-the-industry team and long-term
commitment, we are leading the way to unlock the full promise of
cell therapy as we strive to put more patients on the path to a
cure. If you are ready to challenge yourself, accelerate your
career, and give new hope to patients, there's no better place than
here at BMS with our Cell Therapy team. T he Sr Manager/Associate
Director - Sterility Assurance, Cell therapy technical Operations
reports to the Director, Global Sterility Assurance within the
Technical Operations group in the Cell Therapy Development and
Operations (CTDO) organization. This role will provide technical
oversight to drug product and vector sites as a global SME covering
all aspects of sterility assurance for commercial cell therapy
products manufactured globally via internal and external
manufacturing sites. This role will serve a Global technical SM E,
supporting internal and external manufacturing sites for vector and
drug product . The t eam is accountable for implementation of
technical standards and strategies relating to sterility assurance,
and ensuring sites are aligned in their approach to contamination
control. This role will also cover life cycle management and
implementation of new technologies and strategies with respect to
sterility assurance providing SME guidance of support to CT
manufacturing sites for routine manufacturing and major
investigations. " The role will also provide guidance and support
for all aspects of regulatory submission, inspections, IR responses
process, equipment and supporting elements of manufacturing
validation for all cell therapy products in the portfolio, internal
and external manufacturing processes/facilities for viral vector
and drug product. This person will also support sterility assurance
activities needed during design and build of new manufacturing
plants and new product introductions ensuring compliance with the
global health authority expectations and global standards . Key
Responsibilities:
- Lead, develop and implement scientifically sound and fit for
purpose sterility assurance standards and procedures based on
current regulations, industry trends and best practices for cell
therapy.
- Create, maintain , deploy global cell therapy sterility
assurance technical standards via quality system.
- Promote innovative and efficient approaches to sterility
assurance incorporating risk-based elements and considerations
unique to cell therapy production.
- Serve as global consultant for critical deviations in the
network relating to contamination or microbiological challenges. "
- Support CMC authoring for relevant sections related to
contamination control and APS .
- Promote harmonization and best practices for all aspects of
contamination control .
- Develop and provide guidance for contamination response,
Microbial hold studies, disinfectant efficacy
- Uses trend and scientific data to drive risk-based decisions.
- Drive innovation in sterility assurance for cell therapy
supporting the implementation of new technologies and contamination
control strategies (filtration, VHP, etc.)
- Accountable for development and life cycle management of risk
assessments, regulatory gap assessment
- Support new technology , be a force of innovation by leading
studies which seek to generate scientific data to support ---- .
- Support Network, collaborate with site SME's for
- Technical review for site-level protocol and reports
- Technical review for CMO documentation
- Microbial control strategies for new products
- Oversight of major contamination investigations
- Tech transfer (startup activities for process and plant )
- Act as Cell Therapy liaison to BMS Micro center of excellence
- Participates in external industry groups to gain knowledge of
trends , while serving as an ambassador which seeks to establish
BMS as the Cell Therapy leader.
- Facilitate cell therapy harmonization for existing
manufacturing sites and adoption of industry best practices.
Qualifications & Experience:
- B.S/ MS.S /Ph. D in Microbiology , Biology, or Life Science
with 8 + years of relevant experience in the biopharmaceutical
industry, with direct experience supporting manufacture of
parenteral drugs or ATMP s .
- Ability to lead complex investigations relating to sterility
failure, APS failure, and EM trends such as mold recovery.
- Experience with aseptic technique, environmental monitoring,
EMPQ, APS, disinfection, gowning , isolator technology, ster
ilization validation, and elements of a CCS.
- Experience with QRM and various risk assessment tools .
- E xcellent communication skills and a talent for diplomacy are
essential to the success of this role . This role will collaborate
cross-functionally across a diverse global network of teams .
- Innovative; aims to find practical solutions for complex or
novel applications while upholding regulatory requirements.
- Extensive knowledge of applicable global regulatory standards
which apply to both ATMPs and sterility assurance. Is in touch with
current industry trends and practical interpretation of regulations
as they apply to Cell Therapy .
- Experience with regulatory inspections and CMC
- Experience with Quality Management System.
- Some t ravel (including internationally) may be required , up
to 20% 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. The starting compensation for this job at the
Sr. Manager level is a range from $119,000 - $149,000 (if based in
Summit, NJ), $124,000 - $155,000 (if based in Devens, MA) and
$127,000 - $159,000 (if based in Seattle, WA), plus incentive cash
and stock opportunities (based on eligibility). The starting
compensation for this job at the Associate Director level is a
range from $156,000 - $195,000 (if based in Summit, NJ), $162,000 -
$202,000 (if based in Devens, MA) and $166,000 - $208,000 (if based
in Seattle, WA), 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 our BMS Career Site. 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. #LI-HybridBMSCARTVETERANIf
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, Kent , Sr. Manager / Associate Director, Global Sterility Assurance CTTO, Executive , Seattle, Washington
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