Principal Scientist/Sr Principal Scientist GDE analytical strategy
Company: Bristol Myers Squibb
Location: Warren
Posted on: January 25, 2023
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Job Description:
Working with Us
Challenging. 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
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.
Gene Delivery Product and Analytical Development (GDPAD) leadership
seeks applicants for the Product and Analytical Lead role to drive
strategy and deliverables related to lentiviral, AAV vector, RNP
and raw materials analytics development that are required for CMC
milestone achievement of clinical program. The ideal candidate has
a proven track record in matrix team leadership, CMC strategy,
relationship-building with contract manufacturing organizations
(CMOs) and contract test laboratories (CTLs), with a demonstrated
skill set/knowledge of analytical development. This is a highly
visible role that will serve as the GDPAD single point of contact
for program vector analytics strategy, for CMOs/CTLs, and across
our partner organizations (Process Sciences & Technology, Drug
Product Development; Product and Analytical Development, Quality,
Regulatory, Program teams). The candidate will be accountable for
the analytical strategy that supports QC release, characterization,
and in-process testing of viral vectors used for CART and/or TCR
gene deliver. The candidate will lead a cross-functional team to
deliver vector characterization and QC release assays, successfully
transfer methods to CMOs and CTLs, and coordinate the qualification
thereof.
This position requires CMC strategy experience, project and
cross-functional leadership skills, prioritization and technical
writing, attention to scientific detail and ability to multitask in
high-paced environment.
Responsibilities:
Lead the development of vector control strategy within a
cross-functional team in support of clinical engineered T cell
programs. Establish phase appropriate analytical development,
characterization, and release strategies related to vector, RNP or
raw materials that is aligned across cellular therapeutics
programs.
Manage CMO/CTL relationships to ensure development and
qualification of appropriate analytical methods to enable vector
process development, release and stability testing at CMOs/CTLs
Work with Process and Analytical Development (P&AD) departments
and cross functional partners to build vector process and product
understanding that serves as the foundation of the analytical
strategy including establishing and iterating QTPP, CQAs, and
specifications throughout development.
Establish a flexible and agile matrixed P&AD team that supports
both line function and program deliverables. Lead this team to
ensure on-time CMC deliverables. Summarize and present data in
cross-functional team meetings
Partner with process development and provide vector technical
expertise required to support vector and drug product process
development.
Contribute to regulatory submissions
Accountable for CMC analytical data- type, documentation,
integrity, organization, and integration of datasets with cross
functional partners for development needs and resource
allocations.
Develop and implement planning tools required for timely
communication, efficient prioritization, and resource
allocation.
Identify the opportunities for, and drive alignment of best
practices in policy and strategy across GDPAD and P&AD
departments areas to streamline practices and increase
efficiencies
Basic Qualifications:
Ph.D. degree in virology, analytical sciences, or related field
with experience with CMC strategy and/or drug development
Experience interfacing with GMP contract test laboratories and
contract manufacturing organizations
Demonstrated experience in cross-functional and functional
leadership roles.
Demonstrated collaboration skills working cross functionally,
maintain strong stakeholder relationships, influencing direction,
voicing opinion, and communicating effectively.
Experience authoring technical and regulatory documents. Experience
in drafting, reviewing, approving, and supporting regulatory
filings, including IND amendments, BLAs, and regulatory
responses
Proficient in ICH, FDA, EMA, and JP regulations and guidance.
Proven ability to work in a fast-paced environment, meet deadlines,
& prioritize work on multiple projects.
Strong interpersonal skills including verbal and written
communication are essential in a collaborative work
environment.
The starting compensation for this job is a range from
$114,000-$163,000 (for Washington state) 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-Onsite
BMSCART
Around the world, we are passionate about making an impact on the
lives of patients with serious diseases. Empowered to apply our
individual talents and diverse perspectives in an inclusive
culture, our shared values of passion, innovation, urgency,
accountability, inclusion and integrity bring out the highest
potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the
field is an essential job function of this role which the Company
deems critical to collaboration, innovation, productivity, employee
well-being and engagement, and enhances the Company culture.
To 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.
Our company is committed to ensuring that people with disabilities
can excel through a transparent recruitment process, reasonable
workplace adjustments and ongoing support in their roles.
Applicants can request an approval of accommodation prior to
accepting a job offer. If you require reasonable accommodation in
completing this application or if you are applying to a role based
in the U.S. or Puerto Rico and you believe that you are unable to
receive a COVID-19 vaccine due to a medical condition or sincerely
held religious belief, during or any part of the recruitment
process, please direct your inquiries to adastaffingsupport@bms.com
. Visit careers.bms.com/eeo-accessibility 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, Elizabeth , Principal Scientist/Sr Principal Scientist GDE analytical strategy, Other , Warren, New Jersey
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