Release Manager Lot Disposition - 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 .
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
The Release Manager, QA Disposition Daily Operations is responsible for performing final release and disposition of drug product and issuance of all disposition certification i.e. Certificate of Analysis (CoA), Dose, RFI (release for infusion) certificate at the Summit West facility.
Shift Available:
+ Wednesday - Saturday, Onsite Afternoon Shift, 12 p.m. - 10:30 p.m.
Responsibilities:
+ Meticulous attention to detail to ensure right first time and compliant release and certificate issuance.
+ Current on industry standards as it applies to cGMPs, global regulatory guideline requirements, and departmental requirements.
+ Executes Disposition activities in alignment with all pertinent SOPs. Ensures pertinent SOPs are available and present when executing disposition tasks.
+ Ensures product quality and compliance by enforcing quality assurance policies and procedures; ensures the required processes, procedures, and resources are adhered to while performing responsibilities.
+ Knowledge of US and global cGMP requirements.
+ Advanced knowledge and experience with cGMP manufacturing, quality, and compliance to make appropriate decisions as needed.
+ Obtains all required accesses needed to perform tasks with minimal delay.
+ Action-oriented and customer-focused, skilled in decision-making, building relationships, problem solving, conflict management, and critical thinking.
+ Work is self-directed and requires little to no direction to complete tasks by following work practices, lists, forms, and/or procedures.
+ Skilled in organizing daily tasks, decision-making, and building relationships.
+ Able to adapt as required to support departmental and site wide initiatives.
+ Capable of independently troubleshooting complex situations utilizing all available sources of guidance.
+ Excellent verbal and written skills to prepare clear and concise communications including communication to senior management.
+ Supports and/ or leads continuous improvement initiatives to drive efficiency and productivity within the group and/or site.
+ Responsive in forms of communications.
+ Relays disposition status in a timely manner in all required platforms.
+ Leads projects as required by senior management.
+ Compiles metrics for presentation to senior management as required.
+ Writes, reviews and updates SOPs as required.
+ Recognized as Subject Matter Expert within the group.
+ Additional tasks as instructed by management.
Knowledge & Skills:
+ Detail oriented with strong knowledge of cGMP regulations, regulatory guidelines applicable to biologics and cell therapy.
+ Must be able to interpret problems and effectively communicate with clarity, brevity, and accuracy to peers and leadership.
+ Must be skilled in planning, organizing, conflict management, and innovation management.
+ Contributes to departmental performance and quality initiatives; able to conceptualize impact of quality initiatives in terms of cross-functional teams; emerging as a leader contributing to BMS culture and values.
+ Requires minimal direction to completes tasks, able to obtain resources and information from established internal sources; consults with senior management for complex decisions outside established processes.
+ Routinely recognizes and independently resolves complex quality issues; informs senior management of proposed solutions. Drives solution implementation.
+ Able to interpret complex results and situations with degree of independence and articulate recommendations for solutions.
+ Effectively communicates internally within the function and with internal and external cross-functional teams.
+ Represents department in internal and external cross-functional teams.
+ Manages conflict and issues with internal and external customers.
+ Mentors junior Disposition team members
Basic Requirements:
+ Bachelor's degree required.
+ Equivalent combination of education and experience acceptable.
+ Minimum of 8+ years working in a Quality role within a commercial biopharmaceutical, cellular therapy, or gene therapy organization.
Working Conditions:
+ Work is performed in a typical office environment, with standard office equipment available and used.
+ Work is generally performed seated but may require standing and walking for up to 10% of the time.
+ Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
BMSCART, #LI-Onsite
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: R1586882
Updated: 2024-11-08 05:10:34.124 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 .
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
The Release Manager, QA Disposition Daily Operations is responsible for performing final release and disposition of drug product and issuance of all disposition certification i.e. Certificate of Analysis (CoA), Dose, RFI (release for infusion) certificate at the Summit West facility.
Shift Available:
+ Wednesday - Saturday, Onsite Afternoon Shift, 12 p.m. - 10:30 p.m.
Responsibilities:
+ Meticulous attention to detail to ensure right first time and compliant release and certificate issuance.
+ Current on industry standards as it applies to cGMPs, global regulatory guideline requirements, and departmental requirements.
+ Executes Disposition activities in alignment with all pertinent SOPs. Ensures pertinent SOPs are available and present when executing disposition tasks.
+ Ensures product quality and compliance by enforcing quality assurance policies and procedures; ensures the required processes, procedures, and resources are adhered to while performing responsibilities.
+ Knowledge of US and global cGMP requirements.
+ Advanced knowledge and experience with cGMP manufacturing, quality, and compliance to make appropriate decisions as needed.
+ Obtains all required accesses needed to perform tasks with minimal delay.
+ Action-oriented and customer-focused, skilled in decision-making, building relationships, problem solving, conflict management, and critical thinking.
+ Work is self-directed and requires little to no direction to complete tasks by following work practices, lists, forms, and/or procedures.
+ Skilled in organizing daily tasks, decision-making, and building relationships.
+ Able to adapt as required to support departmental and site wide initiatives.
+ Capable of independently troubleshooting complex situations utilizing all available sources of guidance.
+ Excellent verbal and written skills to prepare clear and concise communications including communication to senior management.
+ Supports and/ or leads continuous improvement initiatives to drive efficiency and productivity within the group and/or site.
+ Responsive in forms of communications.
+ Relays disposition status in a timely manner in all required platforms.
+ Leads projects as required by senior management.
+ Compiles metrics for presentation to senior management as required.
+ Writes, reviews and updates SOPs as required.
+ Recognized as Subject Matter Expert within the group.
+ Additional tasks as instructed by management.
Knowledge & Skills:
+ Detail oriented with strong knowledge of cGMP regulations, regulatory guidelines applicable to biologics and cell therapy.
+ Must be able to interpret problems and effectively communicate with clarity, brevity, and accuracy to peers and leadership.
+ Must be skilled in planning, organizing, conflict management, and innovation management.
+ Contributes to departmental performance and quality initiatives; able to conceptualize impact of quality initiatives in terms of cross-functional teams; emerging as a leader contributing to BMS culture and values.
+ Requires minimal direction to completes tasks, able to obtain resources and information from established internal sources; consults with senior management for complex decisions outside established processes.
+ Routinely recognizes and independently resolves complex quality issues; informs senior management of proposed solutions. Drives solution implementation.
+ Able to interpret complex results and situations with degree of independence and articulate recommendations for solutions.
+ Effectively communicates internally within the function and with internal and external cross-functional teams.
+ Represents department in internal and external cross-functional teams.
+ Manages conflict and issues with internal and external customers.
+ Mentors junior Disposition team members
Basic Requirements:
+ Bachelor's degree required.
+ Equivalent combination of education and experience acceptable.
+ Minimum of 8+ years working in a Quality role within a commercial biopharmaceutical, cellular therapy, or gene therapy organization.
Working Conditions:
+ Work is performed in a typical office environment, with standard office equipment available and used.
+ Work is generally performed seated but may require standing and walking for up to 10% of the time.
+ Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
BMSCART, #LI-Onsite
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: R1586882
Updated: 2024-11-08 05:10:34.124 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
