Location: Brooklyn,NY, USA
**Senior Principal Scientist or Principal Scientist, Gene Delivery Analytical Strategy**
CAROUSEL_PARAGRAPH
* Seattle, Washington; Warren, New Jersey
* Drug Dev and Preclinical Studies
* R1553272
* Full Time
* 02/07/2022
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At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMSs 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, knowledge, and deliverables related to lentiviral, AAV vector 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), and 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 LVV vector 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 Champion 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
* **Principal Scientist** - Minimum 5 - 6 years of relevant experience with required and preferred qualifications
* **Senior Principal Scientist** - Minimum 6 - 8 years of relevant experience with required and preferred qualifications
* 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. Expertise in USP, EP, JP, etc. regulations and guidance
* Proven ability to work in a fast-paced environment, meet deadlines, & prioritize work on multiple projects. Strong attention to detail with the ability to handle multiple responsibilities simultaneously
* Ability to work independently and as part of a team.
* Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
**Preferred Qualifications:**
* Knowledge and direct experience in developing analytical technology and methods for characterizing and release of LVV and/or AAV used in cellular therapeutics. Demonstrated method development experience in techniques such as viral safety and potency assays, viral titer assays, quantitative PCR (qPCR), ddPCR, NGS, ELISA, etc.
* CMC team experience. Demonstrated knowledge of control strategy for CMC programs
* Knowledge and experience with lentiviral and AAV biology
* Experience with engineered T cells using viral gene delivery modalities.
* Track record of successful internal and external technical collaborations.
If you have a passion for taking on new challenges in a fast-paced and dynamic environment, are dedicated to excellence and want to make a difference, we're excited to hear from you! The ideal candidate has a proven track record of innovation, demonstrated skill set and knowledge of viral vectors, in gene editing, analytical development, and is excited to take on new challenges in a fast-paced and dynamic environment. If you are dedicated to excellence and want to make a difference, we're excited to hear from you! This position will report to the Head of Gene Delivery Portfolio Analytical Strategy.
If you want to challenge yourself, accelerate your career, and give new hope to patients, theres 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.
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.
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