Associate Technical Writer, MTS CAR-T Manufacturing S12 - 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 Associate Technical Writer, MTS CAR-T Manufacturing will collaborate with internal Manufacturing partners, such as but not limited to MS&T (Manufacturing Science & Technology), Warehouse, EHS (Environmental Health and Safety) and Quality groups to support the completion of improvement actions (No Impacts, Minors, CAPAs, Change Control Actions and Document updates). Additionally, the Associate is to collect information from triage and initiate the record in the Quality Management System (QMS) with the applicable information.
The Associate Technical Writer, MTS CAR-T Manufacturing will also be responsible for working with the MO and QA teams on CAPAs and Change Control Actions as needed and ensure on time implementation, effectiveness checks and closure of actions. Associates will write, revise, and review all related GMP documentation for S12 CAR-T manufacturing documents.
Shifts Available:
Monday - Friday, Standard Working Hours
Responsibilities:
Deviations
+ Attend alignment meetings, evaluate and provide feedback on severity classification.
+ Able to handle no Impact deviations, which require rapid turnaround.
+ Ability to create and/or review already created QMS deviations, provide feedback when needed, and ensure timelines are met.
+ Complete investigations for minor deviations.
CAPAs
+ Responsible for opening CAPAs as needed to revise, SOPs, Work Instructions, to support new product/process implementation.
+ Ability to complete CAPA Actions as needed within QMS.
+ Ability to complete effectiveness checks that may require historical reviews or spot checks as needed.
+ Responsible for on-time closure of CAPAs and Effectiveness Checks.
+ Ability to work cross-functionally to make necessary updates to procedures/documents to address procedural gaps.
Change Controls
+ Ability to complete change control actions within EQMS as needed.
+ Ability to work cross-functionally to make necessary updates to procedures to address procedural gaps and/or new processes implementation.
+ Responsible for on-time closure of Change Controls Actions
Continuous Improvement
+ Human avoidable deviation reduction driven with continuous improvement.
Required for all job functions
+ Demonstrated ability to collaborate with Manufacturing Operations, QA, MS&T, and other groups to verify the correct reviewers/approvers are selected.
+ Ensuring on time review/approval/effectiveness.
+ Other duties may be assigned, as necessary.
Knowledge & Skills:
+ Must have knowledge of cGMP manufacturing, Quality, FDA and compliance.
+ Knowledge of US and global cGMP requirements.
+ Must possess an independent and critical thinking mindset.
+ Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
+ Builds relationships internally within and with cross functional teams.
+ Contributes to goals within the work group.
+ Able to recognize conflict and notify management with proposed recommendations for resolution.
+ Able to prepare written communications and communicate problems to management with clarity and accuracy.
+ Able to effectively multi-task.
+ Excellent verbal and written communication skills.
+ Understanding of cell culture, cryopreservation, and aseptic processing for cell therapy drug products.
+ Knowledge of cGMP/FDA regulated industry.
+ Strong technical and compliance writing capability.
+ Proficient in MS Office applications
+ Background to include an understanding of biology, chemistry, medical or clinical practices.
Basic Requirements:
+ Bachelor's degree with ability to learn Manufacturing Technical Writing skills.
+ OR Associate/ Medical Technical degree and 1-2 years of Manufacturing or Operations experience.
+ OR High School diploma/GED and 2 years of Manufacturing or Operations experience, with emphasis on Technical Writing and/or QA role.
Working Conditions:
+ On site presence is based on business need and will be communicated by management In our shared office space, designated seating arrangements are available for all Specialists. There will be sufficient lighting and temperature control regardless of season or time of day. Noise ideally is kept to a minimum in this shared environment to maximize your efficiency and communication skills. Heavy lifting and other strenuous activities are unnecessary and should not be performed unless otherwise stated by your manager. Sitting for long periods of time is required for this position, however, at times employees may be obligated to walk to other departments for several reasons. It is recommended, but not required, to get up every hour or so for a short walk as defined in ergonomics training.
+ Although position is primarily office based, some on floor/clean room interactions may be required. Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals and exposure to sanitization agents could be expected. Potential exposure to human blood components and strong magnets. Designated clean room areas will prohibit food, 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.
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: R1585052
Updated: 2024-09-24 04:46:05.852 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 Associate Technical Writer, MTS CAR-T Manufacturing will collaborate with internal Manufacturing partners, such as but not limited to MS&T (Manufacturing Science & Technology), Warehouse, EHS (Environmental Health and Safety) and Quality groups to support the completion of improvement actions (No Impacts, Minors, CAPAs, Change Control Actions and Document updates). Additionally, the Associate is to collect information from triage and initiate the record in the Quality Management System (QMS) with the applicable information.
The Associate Technical Writer, MTS CAR-T Manufacturing will also be responsible for working with the MO and QA teams on CAPAs and Change Control Actions as needed and ensure on time implementation, effectiveness checks and closure of actions. Associates will write, revise, and review all related GMP documentation for S12 CAR-T manufacturing documents.
Shifts Available:
Monday - Friday, Standard Working Hours
Responsibilities:
Deviations
+ Attend alignment meetings, evaluate and provide feedback on severity classification.
+ Able to handle no Impact deviations, which require rapid turnaround.
+ Ability to create and/or review already created QMS deviations, provide feedback when needed, and ensure timelines are met.
+ Complete investigations for minor deviations.
CAPAs
+ Responsible for opening CAPAs as needed to revise, SOPs, Work Instructions, to support new product/process implementation.
+ Ability to complete CAPA Actions as needed within QMS.
+ Ability to complete effectiveness checks that may require historical reviews or spot checks as needed.
+ Responsible for on-time closure of CAPAs and Effectiveness Checks.
+ Ability to work cross-functionally to make necessary updates to procedures/documents to address procedural gaps.
Change Controls
+ Ability to complete change control actions within EQMS as needed.
+ Ability to work cross-functionally to make necessary updates to procedures to address procedural gaps and/or new processes implementation.
+ Responsible for on-time closure of Change Controls Actions
Continuous Improvement
+ Human avoidable deviation reduction driven with continuous improvement.
Required for all job functions
+ Demonstrated ability to collaborate with Manufacturing Operations, QA, MS&T, and other groups to verify the correct reviewers/approvers are selected.
+ Ensuring on time review/approval/effectiveness.
+ Other duties may be assigned, as necessary.
Knowledge & Skills:
+ Must have knowledge of cGMP manufacturing, Quality, FDA and compliance.
+ Knowledge of US and global cGMP requirements.
+ Must possess an independent and critical thinking mindset.
+ Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
+ Builds relationships internally within and with cross functional teams.
+ Contributes to goals within the work group.
+ Able to recognize conflict and notify management with proposed recommendations for resolution.
+ Able to prepare written communications and communicate problems to management with clarity and accuracy.
+ Able to effectively multi-task.
+ Excellent verbal and written communication skills.
+ Understanding of cell culture, cryopreservation, and aseptic processing for cell therapy drug products.
+ Knowledge of cGMP/FDA regulated industry.
+ Strong technical and compliance writing capability.
+ Proficient in MS Office applications
+ Background to include an understanding of biology, chemistry, medical or clinical practices.
Basic Requirements:
+ Bachelor's degree with ability to learn Manufacturing Technical Writing skills.
+ OR Associate/ Medical Technical degree and 1-2 years of Manufacturing or Operations experience.
+ OR High School diploma/GED and 2 years of Manufacturing or Operations experience, with emphasis on Technical Writing and/or QA role.
Working Conditions:
+ On site presence is based on business need and will be communicated by management In our shared office space, designated seating arrangements are available for all Specialists. There will be sufficient lighting and temperature control regardless of season or time of day. Noise ideally is kept to a minimum in this shared environment to maximize your efficiency and communication skills. Heavy lifting and other strenuous activities are unnecessary and should not be performed unless otherwise stated by your manager. Sitting for long periods of time is required for this position, however, at times employees may be obligated to walk to other departments for several reasons. It is recommended, but not required, to get up every hour or so for a short walk as defined in ergonomics training.
+ Although position is primarily office based, some on floor/clean room interactions may be required. Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals and exposure to sanitization agents could be expected. Potential exposure to human blood components and strong magnets. Designated clean room areas will prohibit food, 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.
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: R1585052
Updated: 2024-09-24 04:46:05.852 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
