Associate Director, Cell Therapy Comparability - Bristol Myers Squibb
Summit, NJ
About the Job
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 .
Title: Associate Director, Cell Therapy Comparability
Location: Summit, NJ or Seattle, WA
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 Associate Director, Cell Therapy Comparability will lead comparability programs and collaborate with cross-functional global teams to support for late-stage and commercial cell therapy programs going through critical lifecycle changes, e.g., vector changes, drug product process changes, new manufacturing sites and suites establishment.
This individual will actively drive comparability strategies, anticipate bottlenecks, comparability risks, and proactively address critical issues while fostering a collaborative environment for the matrix team with key supporting functions. They will lead cross-departmental teams, plan risk assessments, and develop strategies for cell therapy comparability. This will involve collaborating with subject matter expert representatives from key functions, including analytical, process, manufacturing, quality, regulatory, etc., and key matrix leaders from CMC and Global Operation teams. Additionally, they will review and provide guidance on strategy in technical protocols and results, ensuring effective communication and execution of comparability across all CMC functional areas. They will play a key role in product lifecycle management, encompassing development, characterization, commercialization, and evolution of cell therapy products. This position requires a strong background in analytical comparability exercises, study design, statistical analysis, and summarizing strategies in technical reports, and communication with global health authorities with submissions.
Key Responsibilities:
+ Drive the design and execution of autologous CART comparability strategy by leveraging in-depth cellular and viral vector product process and analytical knowledge, collaborating closely with cross-functional subject matter experts (SMEs) in CMC, Global Operation, Quality, and Regulatory.
+ Lead the development of comparability risk assessments, establishment of acceptance criteria and justifications, drafting of comparability protocols, etc., in collaboration with biostatisticians and other cross-functional SMEs.
+ Author reports that summarize comparability risk assessments, protocols, study design justifications, acceptance criteria, comparability study outcomes, conclusions, and other critical information.
+ Collaborate with Regulatory CMC and other key functions to design appropriate regulatory submission and communication paths for the programs; and lead technical communications and documentations that summarize the strategy and results from comparability exercises.
+ Utilize existing or develop new quality and technical risk assessment tools and templates to quantify the impact on product safety and efficacy through product quality and process performance assessment of the changes to be evaluated in comparability exercises.
+ Maintain and strengthen relationships across functions, manufacturing sites, and development sites, demonstrating mature stakeholder management skills.
+ Mentor and support other team members to ensure overall team success.
Qualifications & Experience:
+ Ph.D, MSc or BSc in Analytical Science, Chemical Engineering, Biochemical Engineering or equivalent with minimum of 5 (PhD)/ 7 (MSc)/ 10+ (BSc) years relevant experience in drug product development, manufacturing process and analytical sciences, or other disciplines in technical operations.
+ Experiences in leading Cell & Gene therapy comparability projects is preferred, minimally with experience in leading biologics comparability projects.
+ Demonstrated ability to effectively lead in cross-functional teams, meet deadlines, and prioritize multiple projects working in a self-driven, performance/results oriented, fast-paced matrix environment.
+ Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes; knowledge/experiences in vector and autologous/allogenic product manufacturing process is strongly preferred
+ Knowledge of vector and cellular product CQAs and control through manufacturing process
+ Experience with cGMP, ICH guidelines, control strategy development, and working within a Quality organization.
+ Demonstrated strong problem-solving skills.
+ Experience in utilizing MS Office products and statistical software (R, JMP, Minitab, etc.).
+ Ability to creatively manage time and communicate relevant issues to project lead and line management.
+ Strong scientific and excellent written and verbal communication skills; ability to convey complex technical issues to diverse audiences including internal teams, external partners, and health authorities.
+ Detail oriented with excellent verbal and written communication skills.
+ Create an environment of teamwork, open communication, and sense of urgency.
+ Drive strong collaboration within the group and across functions.
+ Build trust and effective relationships with peers and stakeholders.
+ Foster a culture focused on inclusion, solid science, compliance and strong environmental, health, and safety performance.
+ Have a mindset of continuous improvement, problem solving, and prevention.
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.
The starting compensation for this job is a range from $156,000 - $195,000 (if based in Summit, NJ) and $166,000 - $208,000 (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 BMS
Career 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.
#LI-Onsite
BMSCART
VETERAN
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
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/ (https://careers.bms.com/eeo-accessibility) 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1585063
Updated: 2024-09-20 04:55:50.850 UTC
Location: Summit West-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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 .
Title: Associate Director, Cell Therapy Comparability
Location: Summit, NJ or Seattle, WA
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 Associate Director, Cell Therapy Comparability will lead comparability programs and collaborate with cross-functional global teams to support for late-stage and commercial cell therapy programs going through critical lifecycle changes, e.g., vector changes, drug product process changes, new manufacturing sites and suites establishment.
This individual will actively drive comparability strategies, anticipate bottlenecks, comparability risks, and proactively address critical issues while fostering a collaborative environment for the matrix team with key supporting functions. They will lead cross-departmental teams, plan risk assessments, and develop strategies for cell therapy comparability. This will involve collaborating with subject matter expert representatives from key functions, including analytical, process, manufacturing, quality, regulatory, etc., and key matrix leaders from CMC and Global Operation teams. Additionally, they will review and provide guidance on strategy in technical protocols and results, ensuring effective communication and execution of comparability across all CMC functional areas. They will play a key role in product lifecycle management, encompassing development, characterization, commercialization, and evolution of cell therapy products. This position requires a strong background in analytical comparability exercises, study design, statistical analysis, and summarizing strategies in technical reports, and communication with global health authorities with submissions.
Key Responsibilities:
+ Drive the design and execution of autologous CART comparability strategy by leveraging in-depth cellular and viral vector product process and analytical knowledge, collaborating closely with cross-functional subject matter experts (SMEs) in CMC, Global Operation, Quality, and Regulatory.
+ Lead the development of comparability risk assessments, establishment of acceptance criteria and justifications, drafting of comparability protocols, etc., in collaboration with biostatisticians and other cross-functional SMEs.
+ Author reports that summarize comparability risk assessments, protocols, study design justifications, acceptance criteria, comparability study outcomes, conclusions, and other critical information.
+ Collaborate with Regulatory CMC and other key functions to design appropriate regulatory submission and communication paths for the programs; and lead technical communications and documentations that summarize the strategy and results from comparability exercises.
+ Utilize existing or develop new quality and technical risk assessment tools and templates to quantify the impact on product safety and efficacy through product quality and process performance assessment of the changes to be evaluated in comparability exercises.
+ Maintain and strengthen relationships across functions, manufacturing sites, and development sites, demonstrating mature stakeholder management skills.
+ Mentor and support other team members to ensure overall team success.
Qualifications & Experience:
+ Ph.D, MSc or BSc in Analytical Science, Chemical Engineering, Biochemical Engineering or equivalent with minimum of 5 (PhD)/ 7 (MSc)/ 10+ (BSc) years relevant experience in drug product development, manufacturing process and analytical sciences, or other disciplines in technical operations.
+ Experiences in leading Cell & Gene therapy comparability projects is preferred, minimally with experience in leading biologics comparability projects.
+ Demonstrated ability to effectively lead in cross-functional teams, meet deadlines, and prioritize multiple projects working in a self-driven, performance/results oriented, fast-paced matrix environment.
+ Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes; knowledge/experiences in vector and autologous/allogenic product manufacturing process is strongly preferred
+ Knowledge of vector and cellular product CQAs and control through manufacturing process
+ Experience with cGMP, ICH guidelines, control strategy development, and working within a Quality organization.
+ Demonstrated strong problem-solving skills.
+ Experience in utilizing MS Office products and statistical software (R, JMP, Minitab, etc.).
+ Ability to creatively manage time and communicate relevant issues to project lead and line management.
+ Strong scientific and excellent written and verbal communication skills; ability to convey complex technical issues to diverse audiences including internal teams, external partners, and health authorities.
+ Detail oriented with excellent verbal and written communication skills.
+ Create an environment of teamwork, open communication, and sense of urgency.
+ Drive strong collaboration within the group and across functions.
+ Build trust and effective relationships with peers and stakeholders.
+ Foster a culture focused on inclusion, solid science, compliance and strong environmental, health, and safety performance.
+ Have a mindset of continuous improvement, problem solving, and prevention.
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.
The starting compensation for this job is a range from $156,000 - $195,000 (if based in Summit, NJ) and $166,000 - $208,000 (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 BMS
Career 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.
#LI-Onsite
BMSCART
VETERAN
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
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/ (https://careers.bms.com/eeo-accessibility) 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1585063
Updated: 2024-09-20 04:55:50.850 UTC
Location: Summit West-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Source : Bristol Myers Squibb
