Director, Technology Transfer, Analytical & Process Implementations- Cell Therapy
Company: Disability Solutions
Location: Seattle
Posted on: May 3, 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 Summary:Come, join the BMS Cell Therapy
Operations (CTDO) Division, and be a part of the team building
leading cell therapy platforms to serve our patients with novel
cellular immunotherapies. The Cell Therapy Technical Operations
group plays a critical role in technology transfers, process
validation, CMC life cycle management, technical oversight of
external and internal manufacturing partners, process engineering
and establishing manufacturing standards to enable a robust and
scalable global cell therapy manufacturing network. We are looking
for a director to join our Process Robustness team within the Cell
Therapy Technical Operations Function.The successful candidate will
will lead a matrixed cross functional team to enable process and
analytical clinical and/or commercial transfers, support and
implement lifecycle changes, comparability, and support the
start-up of new internal facilities. He/she will participate in
strategic discussions, anticipate bottlenecks, and transfer/
comparability risks, and address issues proactively, while
fostering an environment of teamwork. The person will be
responsible for leading cross-departmental teams, planning risk
assessments and strategy development for cell therapy robustness
activities. The person will collaborate with SMEs, user groups,
quality groups, and other stakeholders to accomplish successful
implementation of robustness initiatives including support process
simulations, transfer lot generation, comparability studies, test
plan generation, operator training, and troubleshooting. The person
will review and provide guidance on strategy in technical protocols
and results in technical reports. This person will collaborate
across all CMC functional areas to ensure project advancement,
rapid and best in class execution, and communication of
challenges/opportunities. The person will play a key role in
product lifecycle management, including development,
characterization, commercialization, and evolution of cell therapy
productsJob Description: Major job duties include:
- Lead and Interface with manufacturing site operations teams and
process/analytical SMEs to implement processes, procedures, and
analytics by applying in-depth CAR-T manufacturing process
knowledge
- Promote innovative and efficient approaches to implementing
robustness initiatives for commercial cell therapy products based
on risk-based elements and considerations unique to cell therapy
production
- Coordinate project planning, timeline, communications, and risk
management activities
- Support manufacturing, QC and QA throughout transfer by
providing training, answering questions, clarifying intent of
procedures, solving problems, and contributing to operational
strategies
- Anticipate and address issues in manufacturing related to
process, documentation, or training
- Provide technical input and investigation support for
deviations/OOS
- Assist in the management of changes, and in the implementation
of process improvements
- Provide technical input in support of regulatory
submissions
- Interact with other CMC teams including Operations, QA,
Development, and Regulatory
- Foster strong inter-team relationships to achieve common
project goals
- Evaluate and assist in statistical design and execution of
comparability exercises for cell therapy products
- Review regulatory filings summarizing the technology transfer
and comparability strategy and results
- Contribute to alignment and harmonization of strategies across
multiple sites and stakeholdersBasic Qualifications:
- Degree in Biology, Chemistry, Biochemical or Chemical
Engineering, or equivalent area of related experience in biologics
upstream manufacturing: Master's degree with 12+ years or Ph.D.
degree with 10+ of experience.
- Candidate should have an advanced degree in Cell Biology with
in-depth knowledge on process and analytical methods.
- Candidate should have the experience of lab start up,
analytical automation and facility start up for cell therapy
products.
- Candidate should have extensive cell therapy manufacturing
experience and have written Commercial Technical Product
Descriptions and Control Strategy documents.
- The candidate must have demonstrated verbal, written, and
communication skills including ability to present complex
information clearly and concisely, with a successful proven history
of working with technical teams.
- Experience should include strong knowledge and technical
leadership and proven track record of managing
comparability/similarity projects.
- Established track record of success with technology transfers
and change management in commercial establishment.
- Extensive knowledge of regulations, current industry practices,
and experience with interpretation and application of guidelines
and regulations.
- Experience in development and/or characterization of biologics
and/or cell therapy manufacturing processes
- Demonstrated leadership skills, and the ability to interact
with and lead diverse groups and teams are essential.
- Proven project management skills (organization, collaboration,
multi-tasking, and communication), attention to detail, and the
ability to perform well in a cross functional team-based
environment are required.
- Prior experience in/knowledge of cell culture, viral vector
manufacturing, recovery and/or purification of viral vector product
in a manufacturing environment required.
- Strong experience with SOPs, change controls, cGMPs and the
know how to work within a regulatory environment required.
- Prior experience facilitating/participating in Risk Assessments
required.Work Environment:
- Position is primarily office based with occasional work in a
classified GMP manufacturing environment
- Position is a team & project-based position that will require
occasional shift work, weekends, and holidaysTravel:This position
may require up to 25% of travelThe 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 BMSCareer 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, South Hill , Director, Technology Transfer, Analytical & Process Implementations- Cell Therapy, IT / Software / Systems , Seattle, Washington
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