Executive Director, Drug Product Process Development- Cell Therapy
Company: Disability Solutions
Location: Seattle
Posted on: October 19, 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:
.Summary:The Executive Director, Drug Product Process Development
is accountable for global network of cell therapy DP process
development. This role is responsible for driving innovation and
implementing end to end practices for leading cell therapy drug
product processes and integrating with the global CT operations
network strategy. Accountable for holistic cell therapy DP process
development strategy to ensure enterprise level considerations are
applied across the portfolio of CT assets including all autologous,
allogeneic and iPSC/NK based approaches, influencing overall CT
development strategy. Role & Responsibilities:
- Lead all cell therapy DP process development activities and
teams across multiple sites
- Partner and collaborate with Accept, Gene Delivery Process &
Analytics Process Development, CT DP Analytics, and GMSAT, and
leverage expertise in the broader BMS development functions as
required
- Develop and implement cost effective and cost competitive
processes for all cell therapy approaches
- Develop phase appropriate FIH processes to enable speed on
portfolio delivery
- Define and harmonize global strategies for developing,
characterizing and enabling validation of CT drug product processes
for both early and late-stage assets as applicable
- Develop and lead global strategy and implementation of DP
process strategy aligned with the internal operations network, the
R&ED strategy and commercial considerations for CT
- Provide technical oversight of CT process related
investigations at internal and external manufacturing sites as
required.
- Lead enterprise assessment of novel technologies including
automation, expression platforms, and associated IP helping to
protect and create value for the BMS portfolio of clinical cell
therapy assets
- Responsible for developing and implementation of PAT as it
relates to CT DP processes in the network, in partnership with
BD
- Partner with GMSAT on automation and LCM for Abecma and
Breyanzi including leadership of Breyanzi single train process
development
- Build high performing teams that excel at working in matrices
across BMS. Attract, hire, manage and develop world class
scientific, technical and engineering talents and create an
environment where they can thrive.
- Create strong partnerships to continually evaluate and evolve
the department's strategic plan to ensure alignment with business
objectives while balancing cost, time and speed.
- Drive engagement with the broader external cell therapy
community and influence direction of the field
- Serve as a member of the Cell Therapy Development leadership
team, participating in portfolio review and project governance
meetings and providing guidance for best practices and direction
for continuous improvement.
- Contribute to, review and approve regulatory CMC submissions to
ensure their quality and technical contentRequirements:
- PhD preferred in biochemistry, biochemical engineering, or
other related field
- Minimum 15 years of experience, leading teams of people
(leading leaders) across multiple geographic locations (-25 %
travel required)
- Demonstrated experience in developing and establishing process
strategies required for early, late, and commercial stage
biological/ cell therapy processes
- Experience with integration of process control strategies with
understanding of attribute sciences
- Broad understanding of metabolomics and CT characteristics as
it relates to production technology
- Experience with multiple analytical techniques used to
characterize and quantify CT approaches
- Experience with process characterization of large molecule
processes
- Ability to work across all cell therapy approaches (autologous,
allogeneic, gene-edited, iPSCs etc)
- Experience partnering with CMC teams to define and deliver tech
strategy required for product licensure.
- Understanding of ICH guidelines
- Experience with partnering externally on product
development
- Understanding of enterprise network strategy and development
execution impact on P<he starting compensation for this job
is a range from $245,000 USD - $325,000 USD, 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 . 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, Renton , Executive Director, Drug Product Process Development- Cell Therapy, Executive , Seattle, Washington
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