Quality Control Supervisor - Bristol Myers Squibb
Indianapolis, IN
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 .
RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
RayzeBio is seeking a Quality Control Supervisor, reporting to the Sr. Manager of Quality Control. The position will oversee quality control testing activities related to radiopharmaceuticals. This role will involve managing a team of QC chemists, ensuring compliance with regulatory and QA system requirements, and maintaining high standards of quality for radiopharmaceutical product release. The Quality Control Supervisor will also ensure laboratory personnel comply with Environmental Health and Radiation safety standards within daily laboratory operations.
The position will be located at RayzeBio's manufacturing plant, in Indianapolis, IN.
Job Responsibilities:
+ Team Management
+ Supervise and mentor a team of QC Chemists.
+ Assign tasks and prioritize workload to ensure timely completion of Quality Control activities, including release of drug product and isotopes in an on-time and right first time manner.
+ Foster a positive and collaborative work environment within the lab and with external stakeholders both within the site and outside the side.
+ Work with Management and Planning to schedule workflow and projects across the Quality Control team.
+ Continuous Improvement
+ Participate in method transfer activities from CMO or internal research facility to the production and QC teams, ensuring accuracy and reliability of data.
+ Identify other opportunities for process improvements and implement changes to increase quality and efficiency within the Quality Control laboratoroies.
+ Provide continuous improvement suggestions for analysis as novel radiopharmaceuticals move through regulatory stages to commercialization.
+ Release of product and other studies
+ Perform analyses of validated/verified methods to support novel RayzeBio Radiopharmaceuticals, raw materials, and components when required.
+ Collaborate with Manager and/or Reviewer to ensure all documentation for release is reviewed.
+ Work with Manager and/or Investigation Write to ensure any discrepancies are resolved in a timely manner.
+ Quality Assurance/Regulatory Compliance
+ Assist in the routine calibration and maintenance of laboratory equipment. Ensure schedule compliance to ensure GMP readiness.
+ Work with Quality Assurance and Management to implement internal audits.
+ Participate in troubleshooting of issues and implement corrective actions to improve quality processes as a result of investigations or internal audits.
+ Develop and maintain appropriate documentation, particularly data analysis and team KPI's.
+ Work with RSO and QA to ensure compliance with GMP regulations, safety guidelines, and quality standards (FDA, USP, NRC, EP, and other regulatory agencies as needed).
+ Assist in the reviewing of Standard Operating Procedures and other documents
+ Weekend work, early starts, or late ending times may be required.
+ Up to 10% of travel may be required.
Education and Experience:
+ BS in chemistry or related field with 9+ years of experience in pharmaceutical field OR MS in chemistry or related field with 7+ years of experience in pharmaceutical field.
+ Experience testing in a quality control chemistry lab.
Preferred Education and Experience:
+ Experience in radiopharmaceutical field
+ Experience handling radioactive materials
Skills:
+ Highly motivated and organized professional with the ability to work independently or in a team environment .
+ Multi-disciplined scientist with GMP experience
+ Experience with root cause techniques such as 6 M's, 5 Why's, fishbone, or similar preferred.
+ Very personable with strong communication skills
+ Ability to multi-task and prioritize work based on multiple work-flows.
+ Good organizational skills are required.
+ Work with multiple computer systems, including Microsoft Office, and chromatography systems.
+ Excellent professional ethics, integrity, and ability to maintain confidential information .
Physical Demands:
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 40 pounds. Specific vision abilities required by this job include close vision and distance vision.
This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials .
Work Environment
The noise level in the work environment is usually moderate.
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: R1585051
Updated: 2024-09-24 04:46:05.661 UTC
Location: Indianapolis-IN
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 .
RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
RayzeBio is seeking a Quality Control Supervisor, reporting to the Sr. Manager of Quality Control. The position will oversee quality control testing activities related to radiopharmaceuticals. This role will involve managing a team of QC chemists, ensuring compliance with regulatory and QA system requirements, and maintaining high standards of quality for radiopharmaceutical product release. The Quality Control Supervisor will also ensure laboratory personnel comply with Environmental Health and Radiation safety standards within daily laboratory operations.
The position will be located at RayzeBio's manufacturing plant, in Indianapolis, IN.
Job Responsibilities:
+ Team Management
+ Supervise and mentor a team of QC Chemists.
+ Assign tasks and prioritize workload to ensure timely completion of Quality Control activities, including release of drug product and isotopes in an on-time and right first time manner.
+ Foster a positive and collaborative work environment within the lab and with external stakeholders both within the site and outside the side.
+ Work with Management and Planning to schedule workflow and projects across the Quality Control team.
+ Continuous Improvement
+ Participate in method transfer activities from CMO or internal research facility to the production and QC teams, ensuring accuracy and reliability of data.
+ Identify other opportunities for process improvements and implement changes to increase quality and efficiency within the Quality Control laboratoroies.
+ Provide continuous improvement suggestions for analysis as novel radiopharmaceuticals move through regulatory stages to commercialization.
+ Release of product and other studies
+ Perform analyses of validated/verified methods to support novel RayzeBio Radiopharmaceuticals, raw materials, and components when required.
+ Collaborate with Manager and/or Reviewer to ensure all documentation for release is reviewed.
+ Work with Manager and/or Investigation Write to ensure any discrepancies are resolved in a timely manner.
+ Quality Assurance/Regulatory Compliance
+ Assist in the routine calibration and maintenance of laboratory equipment. Ensure schedule compliance to ensure GMP readiness.
+ Work with Quality Assurance and Management to implement internal audits.
+ Participate in troubleshooting of issues and implement corrective actions to improve quality processes as a result of investigations or internal audits.
+ Develop and maintain appropriate documentation, particularly data analysis and team KPI's.
+ Work with RSO and QA to ensure compliance with GMP regulations, safety guidelines, and quality standards (FDA, USP, NRC, EP, and other regulatory agencies as needed).
+ Assist in the reviewing of Standard Operating Procedures and other documents
+ Weekend work, early starts, or late ending times may be required.
+ Up to 10% of travel may be required.
Education and Experience:
+ BS in chemistry or related field with 9+ years of experience in pharmaceutical field OR MS in chemistry or related field with 7+ years of experience in pharmaceutical field.
+ Experience testing in a quality control chemistry lab.
Preferred Education and Experience:
+ Experience in radiopharmaceutical field
+ Experience handling radioactive materials
Skills:
+ Highly motivated and organized professional with the ability to work independently or in a team environment .
+ Multi-disciplined scientist with GMP experience
+ Experience with root cause techniques such as 6 M's, 5 Why's, fishbone, or similar preferred.
+ Very personable with strong communication skills
+ Ability to multi-task and prioritize work based on multiple work-flows.
+ Good organizational skills are required.
+ Work with multiple computer systems, including Microsoft Office, and chromatography systems.
+ Excellent professional ethics, integrity, and ability to maintain confidential information .
Physical Demands:
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 40 pounds. Specific vision abilities required by this job include close vision and distance vision.
This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials .
Work Environment
The noise level in the work environment is usually moderate.
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: R1585051
Updated: 2024-09-24 04:46:05.661 UTC
Location: Indianapolis-IN
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