Director, Technical Operations Validation Lead- Cell Therapy
Company: Disability Solutions
Location: Seattle
Posted on: May 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:
careers.bms.com/working-with-us .At 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. Position SummaryThe Director of Validation, Cell
Therapy Technical Operationsreports to the Executive Director, Drug
Product Cell Therapy Technical Operations within the Cell Therapy
Development and Operations (CTDO) organization. This Technical
Leadership role will provide Technical oversight to drug product
and vector sites covering equipment and process validation for
commercial cell therapy products manufactured globally via internal
and external manufacturing sites.This role will be serve as the
Global Technical SME for Drug Product and Vector Validation. The
lead will develop global technical standards for cell therapy
validation and deploy the standards to site MS&T at internal
and external sites. The process responsibilities include developing
process validation standards, process qualification strategy and
framework for cell therapy processes, continuous process
verification (CPV) strategy and implementation in a consistent
manner across products and sites and ensuring that these standards
are reflected in the quality system. Given the broad scope of
validation for the expanding cell therapy global network, this role
will work across the broader CTO organization to ensure alignment
of key focus areas and priorities, develop strategic vision for the
groups, hire and develop the leaders for the sub-function and
recruit the technical talent.The Cell Therapy Lead will cover
process, equipment and supporting elements of manufacturing
validation for all cell therapy products in the portfolio, internal
and external manufacturing processes/facilities for the plasmid,
viral vector and drug product. The person will own the
accountability for the Validation function by providing oversight
of all the validation activities, including providing SME
assessment for proposed process life-cycle changes. The lead will
serve as the Global Point of Contact for sites and will work with
the sights to provide oversight and drive activities utilizing site
Personnel.This person will also support validation activities
needed during design and build of new manufacturing plants to make
sure the engineering approaches consider our harmonized validation
framework that is compliant with the global health authority
expectations and scientifically sound.Key ResponsibilitiesLead,
develop and implement scientifically sound and fit for purpose
validation standards and procedures based on current regulations,
industry standards and industry best practices for cell
therapy.
- Create, maintain, deploy global cell therapy validation
technical standards via quality system.
- Promote innovative and efficient approaches to validation
incorporating risk-based elements and considerations unique to cell
therapy production.
- Lead, develop and implement the master validation plans for
process, equipment, and facilities, in collaboration with the
validation and technical SME network.
- Serve as global consultant for update and revision of exiting
site validation master plans.
- Develop and guide process validation, qualification and process
monitoring strategies and framework.
- Guide the teams to storyboard and present cell therapy global
validation framework, standards, and approaches during major health
authority inspections.
- Ensure timely technical support for validation related
questions for routine manufacturing, lifecycle process changes,
quality audits and health authority inspections.
- Provide oversight via review and approval of network site level
deliverables, including Validation Master Plans, process validation
protocols, impact assessments and risk assessments.
- Author and review CMC summaries of validation for worldwide
regulatory submissions for initialization and life-cycle
changes.
- Design qualification strategies to support novel applications
of fill, filtration, sterilization and single-use disposable
technologies.
- Facilitate cell therapy harmonization for existing
manufacturing sites and adoption of industry best practices.
- Work with process development and analytical development to
ensure early pipeline assets have a robust process for future
validation when in pivotal trials.Qualifications &
ExperienceB.S/MS.S/Ph. D in Chemical Engineering or Life Science
with 12+ years of relevant experience in the biopharmaceutical
company with most of that experience demonstrating progression of
leadership responsibilities and scope.Previous experience should be
a combination of technical operation functions such as
manufacturing, quality, MS&T or Technical Development. At least
10 years of direct experience in GMP environment is necessary.The
leader should have the ability to define the right processes for
the team's maturity level, balancing agility and discipline. Career
track record and industry reputation should be competitive at the
highest level among industry peers.Leader should have demonstrated
skill to lead large, complex technical organizations with global
scope and build people, processes, and technology in a growing
organization. In particular, recruiting and developing strong
technical talent in these diverse areas of scope mentioned above
will be a key consideration. Strong leadership track record
especially in the areas of leading in a global and matrix
environment, working cross functionally and developing strong
technical talent Leader should have excellent communication skills
and be able to strategically influence the direction of the company
in the scope areas mentioned above. This leader will exemplify
strong leadership values and be an internal and external facing
ambassador of the company in the stated areas of scope in this
function. Experience leading regulatory inspections regarding
validation and extensive knowledge of regulations, current industry
practices, and experience with interpretation and application of
guidelines and regulations.Experience with Quality Management
System. Additional preferred qualifications:
- 2-3 years of experience in cell therapy process development and
or manufacturing.
- Combination of experience in process development, MSAT and
quality, experience with manufacturing automation systems/platform
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 is a range from
$178,000- $224,000 (if based in Devens, MA) and $182,000-$229,000
(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. 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 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.
Keywords: Disability Solutions, Sammamish , Director, Technical Operations Validation Lead- Cell Therapy, IT / Software / Systems , Seattle, Washington
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