Director/Senior Director, Gene Delivery Process and Analytical Development
Company: Bristol-Myers Squibb
Location: Seattle
Posted on: January 26, 2023
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: Cell
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 Director/Senior
Director will be accountable of leading the gene delivery
analytical development group within the Gene Delivery Process and
Analytical Development (GDPAD) organization supporting clinical and
commercial cellular products. This group develops release and
characterization methods for our gene delivery materials, which
include lentiviral vectors (LVV), adeno-associated viral vectors
(AAV) and non-viral based gene delivery materials. In addition to
method development and qualification, the group supports method
transfers to Quality Control labs and is responsible for the
determination of our critical quality attributes (CQAs) for gene
delivery materials.. This analytical organization is accountable
for operations involving the execution of the viral vector
determination testing procedure for disposition of a commercial
lentiviral vector. In this capacity the Director/Senior Director
will oversee a large team with responsibility for GMP testing to
support product release and stability, non-GMP testing to support
process development, and various life cycle management initiatives,
including a lab capacity expansion project that is required to
support the increased commercial demand of the product. The
Director/Senior Director will also be part of the GDPAD leadership
team and play a critical role in establishing our high-level
strategies and platforms for viral vector and gene editing raw
material processes and analytical methods. This is a highly visible
and influential role in the organization that will interact
extensively with partner organizations, senior leadership across
BMS, and external collaborators. To be successful in this role, the
ideal candidate must have extensive analytical development
expertise in biotechnology or cell and gene therapy areas,
regulatory and compliance awareness, strategic thinking, strong
business acumen, excellent leadership and influencing
skills.Responsibilities:
- Supervise technical leaders and people managers of the Vector
Release Methods group; hire, mentor and develop exceptional team
members; cultivate diverse and complimentary analytical skill sets
within the group
- Oversee GMP testing operations for vector volume determination
test for a commercial lentiviral vector
- Support method development, qualification and transfer to
Quality Control labs
- Provide technical leadership on gene delivery analytical topics
within group
- Ownership of overall gene delivery analytical platform
- Represent gene delivery analytical development
cross-functionally to members of Process Development, Global
Product Quality, and Cellular Process and Analytical
Development
- Communicate and coordinate with the Gene Delivery Analytical
Strategy team to support program deliverables
- Represent gene delivery analytics at various BMS governance
forums
- Ensure appropriate technical representation from program
activities including author sections of regulatory submissions and
requests for information, technical investigations, and business
development opportunities
- Accountable for documentation practices within the team
including analytical target profiles, method
qualification/technical/method bridging reports, and VVDT quality
systems work product
- Provide regular communications to the team, sub-teams,
functional lines, stakeholders, and management. Escalate issues and
risks and recommend risk mitigation strategies according to
governance procedures.
- Stay abreast of evolving global regulations and industry
practices for the development and approval of Cell Therapy products
worldwide.
- Create a high functioning team, holding team members
accountable for performance, and mentoring/coaching as needed.
Provide input into the performance reviews of team members.Basic
Qualifications:
- B.A./B.S. with --- 18 years of experience or Ph.D. with --- 10
years of experience in biotechnology or cell and gene therapy with
exposure to all stages of product development
- Broad experience in analytical development including method
development, qualification and reviewing relevant regulatory
submissions; knowledge of molecular, biochemical (ELISA), and
high-complexity cell based analytical methods
- Highly developed interpersonal, communication and negotiation
skills, including the ability to clearly articulate complex options
to senior decision makers.
- Experience collaborating with external contract test labs;
understanding risks and typical pitfalls of an external
network
- Demonstrated matrix management skills and clear ability to
influence and effectively align, motivate and empower the team to
progress project goals in a cross-functional matrix
environment.
- Proven ability to work effectively with cross-functional
leaders in a complex/changing global environment.
- Subject-matter expertise to strategically lead the gene
delivery analytical and VVDT teams towards their goals
- Demonstrated experience in preparing and executing complex
strategic plans and balancing competing priorities.
- Strong problem-solving and risk-based decision-making skills
and a strong ability to influence or manage without direct
authority.
- Demonstrated ability for critical and strategic thinkingThe
starting compensation for this job is a range from
$182,000-$262,000 plus incentive cash and stock opportunities
(based on eligibility).The starting pay takes into account
characteristics of the job, such as required skills and where the
job is performed.Final, individual compensation is decided based on
demonstrated experience. For more on benefits, please visit our BMS
Careers site.Eligibility for specific benefits listed in our
careers site may vary based on the job and location.If you want to
challenge yourself, accelerate your career, and give new hope to
patients, there's no better place than here with our Cell Therapy
team. Full of incredible and dedicated team members, those working
on CAR-T and other forms of Cell Therapy are transforming patients'
lives through science. From studying individualized cell lines to
making brand new discoveries, this bold and personal discipline
allows you to grow your career while making a lasting impact on the
field of medicine. Join us today.#LI-OnsiteBMSCARTIf 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 ProtocolPhysical presence at the BMS worksite or
physical presence in the field is a necessary job function of this
role, which the Company deems critical to collaboration,
innovation, productivity, employee well-being and engagement, and
it enhances the Company culture.COVID-19 InformationTo protect the
safety of our workforce, customers, patients and communities, the
policy of the Company requires all employees and workers in the
U.S. and Puerto Rico to be fully vaccinated against COVID-19,
unless they have received an exception based on an approved request
for a medical or religious reasonable accommodation.Therefore, all
BMS applicants seeking a role located in the U.S. and Puerto Rico
must confirm that they have already received or are willing to
receive the full COVID-19 vaccination by their start date as a
qualification of the role and condition of employment.This
requirement is subject to state and local law restrictions and may
not be applicable to employees working in certain jurisdictions
such as Montana. This requirement is also subject to discussions
with collective bargaining representatives in the U.S.BMS is
dedicated to ensuring that people with disabilities can perform
complex functions through a transparent recruitment process,
reasonable workplace adjustments and ongoing support in their
roles. Applicants can request an accommodation prior to accepting a
job offer. If you require reasonable accommodation 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 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: Bristol-Myers Squibb, Seattle , Director/Senior Director, Gene Delivery Process and Analytical Development, Executive , Seattle, Washington
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