Manager, Packaging and Labeling Technical Lead - Bristol Myers Squibb
New Brunswick, 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 .
Our Clinical Supply Operations is responsible for the supply of drug product administered to patients in clinical studies worldwide. In Global Product Development and Supply the team works closely with our partners to deliver quality products safely, efficiently and on time while operationalizing the innovative technologies that will deliver the transformative medicines of tomorrow. As a member of our team, you will get the chance to play a pivotal role to positively impact patients' lives while developing professionally to achieve your own career goals.
Role & Responsibilities:
+ Demonstrates a thorough working knowledge of the clinical supply process and the technical aspects of the CGMP's as they relate to product packaging and labeling. Applies this knowledge to day-to-day packaging and labeling activities that produce finished packaged clinical supplies while ensuring and maintaining compliance with all quality requirements.
+ Reviews the master production schedule and production orders, establishes priorities, and revises schedules according to production order specifications, established priorities and availability of workers, materials, and equipment.
+ Exhibits sound judgment and strong supervisory skills by executing shop floor orders against required timelines while utilizing shop floor resources in an optimized efficient and cost-effective manner.
+ Supervises union staff in all aspects of packaging and labeling of clinical supplies.
+ Print clinical labels utilizing label print software and supervise union staff in the label inspection process.
+ Maintains label stock inventory. Maintain employee records (attendance, vacation etc.) and conduct performance reviews of Hourly staff.
+ Assures all production orders are executed in accordance with CGMP's and departmental SOP's. Utilizing SAP, delivers complete, error free technical documentation supporting packaging & labeling and label inspection production processes.
+ Demonstrates knowledge and familiarity with a range of production equipment and can troubleshoot and resolve problems as they arise. Develops and recommends improvements to facilities, equipment, or procedures to improve quality, safety, and efficiency.
+ Establish and support a work environment of continuous improvements that supports the Company's Quality policy, Quality Systems, and the appropriate regulations for the area.
+ Utilizes technical writing skills to generate procedures and guidelines.
+ Utilizes prior skills to generate Master Batch Recipes Electronic Batch Record system.
+ Participates on high performing teams representing global packaging organization as subject matter expert.
+ Interacts and liaises with team members from CSO, Quality and Analytical & Bioanalytical Development.
+ Oversees and or conducts training of new or existing employees and ensures their training is documented.
+ Ensures that health and safety guidelines are followed. Maintains CGMP/Housekeeping at a high level within the department.
+ Leads root cause investigations for process deviations and assigns Corrective/Preventative Actions.
+ Conducts Cleaning Verification swab submission for product contact parts
Experience & Qualifications:
+ Bachelor of Science or Mechanical Engineering Degree, or an equivalent amount of relevant experience may substitute
+ 5+ years in a pharmaceutical industry preferably pharmaceutical manufacturing with a focus in the production of Clinical Trial Supplies.
+ 3-5 years of progressive leadership or supervisory experience in the pharmaceutical industry
+ Working knowledge and experience in lean /six sigma tools and concepts; 5S, Kanban, Kaizen, Green Belt Black Belt, etc.
+ Prior Supervision of production staff or leadership role within a production operation with demonstrated ability in scheduling, organizing and team building is required.
+ Strong working knowledge of cGMP's and regulatory (i.e., FDA, EU, OSHA, etc.) requirements and their application within a packaging and labeling production environment. Solid record of attention to detail and strict adherence to all procedures and regulations.
+ Good understanding of the pharmaceutical development process and associated scientific principles, Excellent written and communication skills. Demonstrated ability to liaise with various support groups and lead in a team environment.
+ Effectively manage competing priorities, adaptable to change, demonstrated ability to accept additional responsibilities and mange tasks thought teamwork.
+ Basic working knowledge of computers using MS Office, MS Outlook and business software systems commonly used in pharmaceutical industry (i.e., Electronic Batch Records).
+ Prior experience in recipe building/ Master Recipe creation within MES/Electronic Batch Record systems
#GPSProdDev
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: R1587440
Updated: 2024-11-21 03:16:23.739 UTC
Location: New Brunswick-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 .
Our Clinical Supply Operations is responsible for the supply of drug product administered to patients in clinical studies worldwide. In Global Product Development and Supply the team works closely with our partners to deliver quality products safely, efficiently and on time while operationalizing the innovative technologies that will deliver the transformative medicines of tomorrow. As a member of our team, you will get the chance to play a pivotal role to positively impact patients' lives while developing professionally to achieve your own career goals.
Role & Responsibilities:
+ Demonstrates a thorough working knowledge of the clinical supply process and the technical aspects of the CGMP's as they relate to product packaging and labeling. Applies this knowledge to day-to-day packaging and labeling activities that produce finished packaged clinical supplies while ensuring and maintaining compliance with all quality requirements.
+ Reviews the master production schedule and production orders, establishes priorities, and revises schedules according to production order specifications, established priorities and availability of workers, materials, and equipment.
+ Exhibits sound judgment and strong supervisory skills by executing shop floor orders against required timelines while utilizing shop floor resources in an optimized efficient and cost-effective manner.
+ Supervises union staff in all aspects of packaging and labeling of clinical supplies.
+ Print clinical labels utilizing label print software and supervise union staff in the label inspection process.
+ Maintains label stock inventory. Maintain employee records (attendance, vacation etc.) and conduct performance reviews of Hourly staff.
+ Assures all production orders are executed in accordance with CGMP's and departmental SOP's. Utilizing SAP, delivers complete, error free technical documentation supporting packaging & labeling and label inspection production processes.
+ Demonstrates knowledge and familiarity with a range of production equipment and can troubleshoot and resolve problems as they arise. Develops and recommends improvements to facilities, equipment, or procedures to improve quality, safety, and efficiency.
+ Establish and support a work environment of continuous improvements that supports the Company's Quality policy, Quality Systems, and the appropriate regulations for the area.
+ Utilizes technical writing skills to generate procedures and guidelines.
+ Utilizes prior skills to generate Master Batch Recipes Electronic Batch Record system.
+ Participates on high performing teams representing global packaging organization as subject matter expert.
+ Interacts and liaises with team members from CSO, Quality and Analytical & Bioanalytical Development.
+ Oversees and or conducts training of new or existing employees and ensures their training is documented.
+ Ensures that health and safety guidelines are followed. Maintains CGMP/Housekeeping at a high level within the department.
+ Leads root cause investigations for process deviations and assigns Corrective/Preventative Actions.
+ Conducts Cleaning Verification swab submission for product contact parts
Experience & Qualifications:
+ Bachelor of Science or Mechanical Engineering Degree, or an equivalent amount of relevant experience may substitute
+ 5+ years in a pharmaceutical industry preferably pharmaceutical manufacturing with a focus in the production of Clinical Trial Supplies.
+ 3-5 years of progressive leadership or supervisory experience in the pharmaceutical industry
+ Working knowledge and experience in lean /six sigma tools and concepts; 5S, Kanban, Kaizen, Green Belt Black Belt, etc.
+ Prior Supervision of production staff or leadership role within a production operation with demonstrated ability in scheduling, organizing and team building is required.
+ Strong working knowledge of cGMP's and regulatory (i.e., FDA, EU, OSHA, etc.) requirements and their application within a packaging and labeling production environment. Solid record of attention to detail and strict adherence to all procedures and regulations.
+ Good understanding of the pharmaceutical development process and associated scientific principles, Excellent written and communication skills. Demonstrated ability to liaise with various support groups and lead in a team environment.
+ Effectively manage competing priorities, adaptable to change, demonstrated ability to accept additional responsibilities and mange tasks thought teamwork.
+ Basic working knowledge of computers using MS Office, MS Outlook and business software systems commonly used in pharmaceutical industry (i.e., Electronic Batch Records).
+ Prior experience in recipe building/ Master Recipe creation within MES/Electronic Batch Record systems
#GPSProdDev
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: R1587440
Updated: 2024-11-21 03:16:23.739 UTC
Location: New Brunswick-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