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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.
Position Summary
The Product Analytical Program and Method Transfer Lead drives Cell Therapy clinical program analytical technical strategy and global Method Transfer required to deliver Chemical Manufacturing Control (CMC) program milestones. The ideal candidate has a proven track record of technical proficiency, experience with analytical CMC matrix team leadership, product analytical strategy, analytical Method Transfer, understanding of technical capabilities of contract manufacturing organizations and contract test laboratories and demonstrated skillset/knowledge of analytical development. This position will serve as Product and Analytical Development (P&AD) department all clinical programs' analytical Method Transfer Lead, and single point of contact for technical aspects of a program's analytical strategy in a matrix team supporting product release, characterization and in-process testing of cellular drug product.
Key Responsibilities
Analytical Program Lead Role:
Analytical Transfer Lead Role:
Qualifications & Experience
The starting compensation for this job is a range from $149,0000-$188,000 (For Washington State) 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 website https://careers.bms.com/working-with-us
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.
BMSCART
#LI-hybrid
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 Careers
With 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
Physical 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.
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.
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.
Position Summary
The Product Analytical Program and Method Transfer Lead drives Cell Therapy clinical program analytical technical strategy and global Method Transfer required to deliver Chemical Manufacturing Control (CMC) program milestones. The ideal candidate has a proven track record of technical proficiency, experience with analytical CMC matrix team leadership, product analytical strategy, analytical Method Transfer, understanding of technical capabilities of contract manufacturing organizations and contract test laboratories and demonstrated skillset/knowledge of analytical development. This position will serve as Product and Analytical Development (P&AD) department all clinical programs' analytical Method Transfer Lead, and single point of contact for technical aspects of a program's analytical strategy in a matrix team supporting product release, characterization and in-process testing of cellular drug product.
Key Responsibilities
Analytical Program Lead Role:
- Develop actionable strategies and plans that ensure alignment with short-term and long-term objectives developed in tandem with P&AD leadership.
- Direct analytical strategy implementation, resources and overall project execution
- Work with P&AD department and functional partners to build cellular process and product understanding that serves as a foundation of the analytical strategy
- Partner with P&AD, Process Development, Quality, Manufacturing leaders to foster cross-functional collaboration and appropriate alignment
- Exemplify and drive technical excellence through portfolio analytical strategy development and advocacy
- Contribute to DP analytical risk identification, assessment and mitigation
- Ensure strategy/status/summary data/issues/plans for functional areas are presented at relevant meetings and governance board
- Accountable for drug product specifications and justification of specifications for clinical programs
- Serve as author/reviewer for analytical sections of CMC submissions and responses to regulatory questions
Analytical Transfer Lead Role:
- Lead analytical Method Transfer from Analytical Development to QC or between different QC laboratories.
- Define analytical Method Transfer strategy and timeline based on the method status, lab readiness. Author transfer plan and transfer summary report.
- Work closely with Process team and receiving site QC to make sure that the analytical Method Transfer timeline align with process transfer timeline.
- Work with SMEs to prepare analytical Method Transfer packages (methods and related SOP, instruments, materials, et al).
- Organize cross-functional (analytical development, QC and QA) and cross-site meetings and oversee the execution of transfer related activities. Coordinate discrepancy investigations.
- Coordinate trainings between sending site and receiving site.
- Work with SME and relevant department to Identify samples and materials for training and transfer.
- Review analytical Method Transfer protocols/reports or co-validation protocols/reports.
Qualifications & Experience
- Ph.D. or Master degree in analytical sciences or related fields with minimum 7 (for Ph. D.) or 10 (for Master and other relevant degrees) years of experience in the development and approval of cell & gene therapy products or biologics or other relevant fields.
- Extensive experiences with CMC analytical strategy and demonstrated technical proficiency.
- Extensive experiences with successful analytical Method Transfer especially in complex scenarios with multiple labs involved
- Good communication skills and be able to work cross-functionally with QC, QA, analytical development and CRO
- Demonstrated ability to attention to scientific details and to multi-task in a high paced environment
- Extensive experience and knowledge with engineered T cells and gene editing technologies are preferred
- Demonstrated collaboration skills working cross functionally, maintain strong stakeholder relationships and influencing scientific rigor
- Demonstrated ability to draw insights from large data quickly, perform analysis, and present scientific rationale.
- Experience in authoring technical and Regulatory documents. Experience in drafting, reviewing, approving and supporting regulatory filings including IND amendments, BLAs, briefing books, and regulatory responses.
The starting compensation for this job is a range from $149,0000-$188,000 (For Washington State) 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 website https://careers.bms.com/working-with-us
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.
BMSCART
#LI-hybrid
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 Careers
With 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
Physical 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.
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.
