Specialist, Lead Manufacturing Associate, Cell Therapy - 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 Specialist, Lead Manufacturing Associate, Cell Therapy manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality
investigations are required, as applicable.
Shifts Available:
Breyanzi - Harvest
1 - Quad 1: 5am - 5:30pm Sunday - Tues and every other Wed.
1 - Quad 2: 5pm - 5:30am Sunday - Tues and every other Wed.
3 - Quad 4: 5pm - 5:30am Thur - Sat and every other Wed.
Responsibilities:
+ Oversee set-up and operation of equipment to support production of blood component lots through culture expansion, cell counting, data entry and media addition while maintaining good aseptic technique.
+ Lead deviation investigations and write ups as needed. Accountable for on time closure of any assigned CAPAs within the designated shift.
+ Good aseptic technique is required for most activities: tube welding, connections, and transfers, at minimum.
+ Weigh and measure in-process materials to ensure proper quantities are added/removed.
+ Adheres to the production schedule ensuring on-time, internal production logistics.
+ Records production data and information in a clear, concise, format according to proper GDPs.
+ Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.
+ Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
+ Must be highly motivated, team oriented with strong patient focus to fulfill job requirements.
+ Is a SME and qualified trainer within a designated function of manufacturing. Team Lead is responsible for the designated area within the shift. Shift supervision will be managed by the shift Supervisor, but Team Lead will act as Supervisor when needed.
+ Maintain on time completion of training assignments and those of the associates in the designated area to ensure the necessary technical skills and process knowledge required to execute operations in a GMP compliant manner.
+ Lead shift daily review and correction of all logbooks in the processing suites.
+ Performs other tasks as assigned: Lead continuous improvement projects, inspection readiness, right first-time initiatives, etc.
+ Issue pre/post shift reports and escalate issues for timely resolution.
Knowledge & Skills:
+ Advanced understanding of cell culture, cell expansion and aseptic processing or lab techniques within a cleanroom.
+ Familiarity with Lean Manufacturing initiatives
+ Knowledge of cGMP/FDA regulated industry requirements
+ Basic mathematical skills
+ Technical writing capability to support batch record revisions, deviation investigations, and closure of CAPAs.
+ Proficient in MS Office applications
+ Background to include an understanding of biology, chemistry, medical or clinical practices
+ Must be a Qualified Trainer in Expansion Operations with ability and willingness to train others
Basic Requirements:
+ Master's degree plus 1-2 years of experience in cell therapy or biopharmaceutical operations
+ OR Bachelor's degree plus 2-4 years of experience in cell therapy or biopharmaceutical operations
+ OR Associate/ Medical Technical degree and 6+ years of Manufacturing or Operations experience
+ OR High School diploma/GED and 8+ years of Manufacturing or Operations experience.
Working Conditions:
+ Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
+ Physical dexterity sufficient to use computers and documentation.
+ Sufficient vision and hearing capability to work in job environment.
+ Ability to lift up to 25 pounds.
+ Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
+ Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
+ Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
+ Flexibility to don clean room garments and personal protective equipment (PPE).
+ Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
+ Routine exposure to human blood components.
+ Designated manufacturing areas prohibit food, and any outside materials such as cell phones, tablets, at a minimum.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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: R1584658
Updated: 2024-11-29 07:36:06.026 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 Specialist, Lead Manufacturing Associate, Cell Therapy manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality
investigations are required, as applicable.
Shifts Available:
Breyanzi - Harvest
1 - Quad 1: 5am - 5:30pm Sunday - Tues and every other Wed.
1 - Quad 2: 5pm - 5:30am Sunday - Tues and every other Wed.
3 - Quad 4: 5pm - 5:30am Thur - Sat and every other Wed.
Responsibilities:
+ Oversee set-up and operation of equipment to support production of blood component lots through culture expansion, cell counting, data entry and media addition while maintaining good aseptic technique.
+ Lead deviation investigations and write ups as needed. Accountable for on time closure of any assigned CAPAs within the designated shift.
+ Good aseptic technique is required for most activities: tube welding, connections, and transfers, at minimum.
+ Weigh and measure in-process materials to ensure proper quantities are added/removed.
+ Adheres to the production schedule ensuring on-time, internal production logistics.
+ Records production data and information in a clear, concise, format according to proper GDPs.
+ Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.
+ Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
+ Must be highly motivated, team oriented with strong patient focus to fulfill job requirements.
+ Is a SME and qualified trainer within a designated function of manufacturing. Team Lead is responsible for the designated area within the shift. Shift supervision will be managed by the shift Supervisor, but Team Lead will act as Supervisor when needed.
+ Maintain on time completion of training assignments and those of the associates in the designated area to ensure the necessary technical skills and process knowledge required to execute operations in a GMP compliant manner.
+ Lead shift daily review and correction of all logbooks in the processing suites.
+ Performs other tasks as assigned: Lead continuous improvement projects, inspection readiness, right first-time initiatives, etc.
+ Issue pre/post shift reports and escalate issues for timely resolution.
Knowledge & Skills:
+ Advanced understanding of cell culture, cell expansion and aseptic processing or lab techniques within a cleanroom.
+ Familiarity with Lean Manufacturing initiatives
+ Knowledge of cGMP/FDA regulated industry requirements
+ Basic mathematical skills
+ Technical writing capability to support batch record revisions, deviation investigations, and closure of CAPAs.
+ Proficient in MS Office applications
+ Background to include an understanding of biology, chemistry, medical or clinical practices
+ Must be a Qualified Trainer in Expansion Operations with ability and willingness to train others
Basic Requirements:
+ Master's degree plus 1-2 years of experience in cell therapy or biopharmaceutical operations
+ OR Bachelor's degree plus 2-4 years of experience in cell therapy or biopharmaceutical operations
+ OR Associate/ Medical Technical degree and 6+ years of Manufacturing or Operations experience
+ OR High School diploma/GED and 8+ years of Manufacturing or Operations experience.
Working Conditions:
+ Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
+ Physical dexterity sufficient to use computers and documentation.
+ Sufficient vision and hearing capability to work in job environment.
+ Ability to lift up to 25 pounds.
+ Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
+ Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
+ Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
+ Flexibility to don clean room garments and personal protective equipment (PPE).
+ Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
+ Routine exposure to human blood components.
+ Designated manufacturing areas prohibit food, and any outside materials such as cell phones, tablets, at a minimum.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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: R1584658
Updated: 2024-11-29 07:36:06.026 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