Associate Director, Cell Therapy Comparability
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:
Associate Director, Cell Therapy ComparabilityLocation: Summit, NJ
or Seattle, WACell Therapy is one of the most groundbreaking new
forms of cancer treatments being studied today. With therapies only
in their infancy and BMS's continued investment in our Cell Therapy
capabilities, the growth potential of this science, your career,
and the ability to help patients are incredible.The Associate
Director, Cell Therapy Comparability will lead comparability
programs and collaborate with cross-functional global teams to
support for late-stage and commercial cell therapy programs going
through critical lifecycle changes, e.g., vector changes, drug
product process changes, new manufacturing sites and suites
establishment.This individual will actively drive comparability
strategies, anticipate bottlenecks, comparability risks, and
proactively address critical issues while fostering a collaborative
environment for the matrix team with key supporting functions. They
will lead cross-departmental teams, plan risk assessments, and
develop strategies for cell therapy comparability. This will
involve collaborating with subject matter expert representatives
from key functions, including analytical, process, manufacturing,
quality, regulatory, etc., and key matrix leaders from CMC and
Global Operation teams. Additionally, they will review and provide
guidance on strategy in technical protocols and results, ensuring
effective communication and execution of comparability across all
CMC functional areas. They will play a key role in product
lifecycle management, encompassing development, characterization,
commercialization, and evolution of cell therapy products. This
position requires a strong background in analytical comparability
exercises, study design, statistical analysis, and summarizing
strategies in technical reports, and communication with global
health authorities with submissions.Key Responsibilities:
- Drive the design and execution of autologous CART comparability
strategy by leveraging in-depth cellular and viral vector product
process and analytical knowledge, collaborating closely with
cross-functional subject matter experts (SMEs) in CMC, Global
Operation, Quality, and Regulatory.
- Lead the development of comparability risk assessments,
establishment of acceptance criteria and justifications, drafting
of comparability protocols, etc., in collaboration with
biostatisticians and other cross-functional SMEs.
- Author reports that summarize comparability risk assessments,
protocols, study design justifications, acceptance criteria,
comparability study outcomes, conclusions, and other critical
information.
- Collaborate with Regulatory CMC and other key functions to
design appropriate regulatory submission and communication paths
for the programs; and lead technical communications and
documentations that summarize the strategy and results from
comparability exercises.
- Utilize existing or develop new quality and technical risk
assessment tools and templates to quantify the impact on product
safety and efficacy through product quality and process performance
assessment of the changes to be evaluated in comparability
exercises.
- Maintain and strengthen relationships across functions,
manufacturing sites, and development sites, demonstrating mature
stakeholder management skills.
- Mentor and support other team members to ensure overall team
success.Qualifications & Experience:
- Ph.D, MSc or BSc in Analytical Science, Chemical Engineering,
Biochemical Engineering or equivalent with minimum of 7 (PhD)/5
(MSc)/10+ (BSc) years relevant experience in drug product
development, manufacturing process and analytical sciences, or
other disciplines in technical operations.
- Experiences in leading Cell & Gene therapy comparability
projects is preferred, minimally with experience in leading
biologics comparability projects.
- Demonstrated ability to effectively lead in cross-functional
teams, meet deadlines, and prioritize multiple projects working in
a self-driven, performance/results oriented, fast-paced matrix
environment.
- Experience in development and/or characterization of biologics
and/or cell therapy manufacturing processes; knowlege/experiences
in vector and autologous/allogenic product manufacturing process is
strongly preferred
- Knowledge of vector and cellular product CQAs and control
through manufacturing process
- Experience with cGMP, ICH guidelines, control strategy
development, and working within a Quality organization.
- Demonstrated strong problem-solving skills.
- Experience in utilizing MS Office products and statistical
software (R, JMP, Minitab, etc.).
- Ability to creatively manage time and communicate relevant
issues to project lead and line management.
- Strong scientific and excellent written and verbal
communication skills; ability to convey complex technical issues to
diverse audiences including internal teams, external partners, and
health authorities.
- Detail oriented with excellent verbal and written communication
skills.
- Create an environment of teamwork, open communication, and
sense of urgency.
- Drive strong collaboration within the group and across
functions.
- Build trust and effective relationships with peers and
stakeholders.
- Foster a culture focused on inclusion, solid science,
compliance and strong environmental, health, and safety
performance.
- Have a mindset of continuous improvement, problem solving, and
prevention. f 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 $156,000 - $195,000 (if based in Summit, NJ) 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-OnsiteBMSCARTVETERANIf
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 , Associate Director, Cell Therapy Comparability, Executive , Seattle, Washington
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