Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations
Myokardia, Denville, NJ, United States
Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations
Summit West - NJ - US
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. 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.
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.
Our Manufacturing Associate, Cell Therapy team manufactures human blood-derived components per Batch Record and Standard Operating Procedures 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.
Shift Available:
Wednesday - Saturday (with e/o Wednesday off), Onsite Overnight Shift, 5 p.m. - 5:30 a.m.
*Start and end times are subject to change based on business demands.
Responsibilities:
Learn and execute Cell Therapy Manufacturing operations compliantly.
Execute operations as outlined in Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms).
Executes transactions and process in all electronic systems and adheres to business continuity processes.
Prioritizes safety of self and others.
Reports safety events within 24 hours.
Immediately escalates any/all issues that may impact compliance or safety of self and/or others.
Complete documentation required by Source Governing Documents contemporaneously.
Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements including ALCOA+.
Complete training assignments prior to assigned due date to ensure necessary technical skills and knowledge.
Train for proficiency in process systems and some supporting business systems.
Execute the daily unit operations schedule, that includes people, product, and material flow across multiple shifts.
Work within a control cleanroom environment and execute aseptic processing procedures (as assigned).
Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.
Continues to refine and improve manufacturing process technique to improve individual operational times.
Verifies training completion prior to performing any GxP tasks.
Author Manufacturing operating procedures that are technically sound, promote effective and efficient operations and comply with cGMP requirements.
Knowledge & Skills:
Proven experience working on teams where collaboration and results were expected.
Proficiency in common computer tools such as word processing, spreadsheet and web-based applications.
Meticulous attention to detail and personal accountability is critical to success.
Possess excellent interpersonal skills, is attentive and approachable.
Maintain a professional and productive relationship with area management and co-workers.
Basic understanding of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.
Minimum Requirements:
High School Diploma required. Bachelor's or associate degree preferred.
0-1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience.
Working Conditions:
Must be able to stand/walk for extended periods of time.
Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets (as assigned), which require gowning and personal protective equipment (PPE), including by not limited to: safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves, and hearing protection.
Required to carry and/or lift up to 30 pounds / 15 kg, several times a day, while handling production equipment and/or materials.
Required to push and/or pull up to 50 pounds / 25 kg, several times a day, while handling production equipment and/or materials.
Work in areas that may have strong magnets.
Must be able to work in a BSL2 / ML1 work environment handling human blood components.
Work in areas with exposure to vapor phase liquid nitrogen.
Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays).
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.
Compensation Overview:
Summit West - NJ - US: $27.83 - $33.72per hour
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. 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 https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:
Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager.
Summit West - NJ - US
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. 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.
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.
Our Manufacturing Associate, Cell Therapy team manufactures human blood-derived components per Batch Record and Standard Operating Procedures 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.
Shift Available:
Wednesday - Saturday (with e/o Wednesday off), Onsite Overnight Shift, 5 p.m. - 5:30 a.m.
*Start and end times are subject to change based on business demands.
Responsibilities:
Learn and execute Cell Therapy Manufacturing operations compliantly.
Execute operations as outlined in Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms).
Executes transactions and process in all electronic systems and adheres to business continuity processes.
Prioritizes safety of self and others.
Reports safety events within 24 hours.
Immediately escalates any/all issues that may impact compliance or safety of self and/or others.
Complete documentation required by Source Governing Documents contemporaneously.
Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements including ALCOA+.
Complete training assignments prior to assigned due date to ensure necessary technical skills and knowledge.
Train for proficiency in process systems and some supporting business systems.
Execute the daily unit operations schedule, that includes people, product, and material flow across multiple shifts.
Work within a control cleanroom environment and execute aseptic processing procedures (as assigned).
Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.
Continues to refine and improve manufacturing process technique to improve individual operational times.
Verifies training completion prior to performing any GxP tasks.
Author Manufacturing operating procedures that are technically sound, promote effective and efficient operations and comply with cGMP requirements.
Knowledge & Skills:
Proven experience working on teams where collaboration and results were expected.
Proficiency in common computer tools such as word processing, spreadsheet and web-based applications.
Meticulous attention to detail and personal accountability is critical to success.
Possess excellent interpersonal skills, is attentive and approachable.
Maintain a professional and productive relationship with area management and co-workers.
Basic understanding of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.
Minimum Requirements:
High School Diploma required. Bachelor's or associate degree preferred.
0-1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience.
Working Conditions:
Must be able to stand/walk for extended periods of time.
Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets (as assigned), which require gowning and personal protective equipment (PPE), including by not limited to: safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves, and hearing protection.
Required to carry and/or lift up to 30 pounds / 15 kg, several times a day, while handling production equipment and/or materials.
Required to push and/or pull up to 50 pounds / 25 kg, several times a day, while handling production equipment and/or materials.
Work in areas that may have strong magnets.
Must be able to work in a BSL2 / ML1 work environment handling human blood components.
Work in areas with exposure to vapor phase liquid nitrogen.
Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays).
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.
Compensation Overview:
Summit West - NJ - US: $27.83 - $33.72per hour
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. 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 https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:
Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager.