QC Analytical Manager, Molecular, Cell Therapy in Devens, MA
Bristol-Myers Squibb
QC Analytical Manager, Molecular, Cell Therapy in Devens, MA
Job Description
Supervise the QC Analytical lab staff on shift and oversee the daily lab activities related to in-process, final release, and stability testing of cell therapy drug product. Develop and execute a work plan for the shift, ensuring safety, quality, and performance targets are achieved. Perform QC data review ensuring results are compliant with specifications and regulations. Report abnormalities. Track, trend, and report key performance metrics. Drive continuous improvement in the lab to increase productivity and efficiency. May collaborate with other departments to identify and implement process improvements. Review and approve test methods and procedures to ensure operational alignment and compliance with corporate policies and procedures. Own and evaluate relevant change controls, investigations, deviations, CAPAs. Hire, mentor, and develop team members to support the business operations and employee career development. Oversee training of the team members. Communicate effectively with management regarding task completion, roadblocks, and needs. Responsible for cGMP compliance in all aspects of laboratory operations. Participate in site team supporting and managing regulatory inspections and findings. Perform other tasks as assigned. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Supporting People with Disabilities Experience with various bioanalytical techniques (cell-based assays, ELISA, qPCR, flow cytometry) and associated equipment. Experience with laboratory LIMS, ELN, and ERP systems (e.g., SAP) preferred. Ability to work in a highly regulated environment and follow regulatory requirements and GMPs. Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environment. Advanced ability to work collaboratively in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. Excellent organizational and critical thinking skills. Advanced problem-solving ability/mentality, technically adept and logical. Advanced ability to communicate effectively with peers, department management, and cross functional peers. Proficient with Excel, Visio, PowerPoint, and other common software applications. The incumbent will be working around biohazardous materials. Bachelor's degree required, preferably in Chemistry, Microbiology or related science. 6+ years of relevant laboratory work experience, preferably in a regulated environment. 2+ years of management and people leader experience. An equivalent combination of education and experience may substitute.
About the Role/Company
- The company supports people with disabilities
Key Responsibilities
- Supervise the QC Analytical lab staff on shift and oversee daily lab activities related to in-process, final release, and stability testing of cell therapy drug product
- Develop and execute a work plan for the shift, ensuring safety, quality, and performance targets are achieved
- Perform QC data review ensuring results are compliant with specifications and regulations
- Report abnormalities
- Track, trend, and report key performance metrics
- Drive continuous improvement in the lab to increase productivity and efficiency
- Collaborate with other departments to identify and implement process improvements
- Review and approve test methods and procedures to ensure operational alignment and compliance with corporate policies and procedures
- Own and evaluate relevant change controls, investigations, deviations, CAPAs
- Hire, mentor, and develop team members to support the business operations and employee career development
- Oversee training of the team members
- Communicate effectively with management regarding task completion, roadblocks, and needs
- Responsible for cGMP compliance in all aspects of laboratory operations
- Participate in site team supporting and managing regulatory inspections and findings
- Perform other tasks as assigned
Required Qualifications
- Bachelor's degree, preferably in Chemistry, Microbiology or related science
- + years of relevant laboratory work experience, preferably in a regulated environment
- + years of management and people leader experience
Preferred Qualifications
- Experience with laboratory LIMS, ELN, and ERP systems (e.g., SAP)
Skills Required
- Experience with various bioanalytical techniques (cell-based assays, ELISA, qPCR, flow cytometry) and associated equipment
- Ability to work in a highly regulated environment and follow regulatory requirements and GMPs
- Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environment
- Advanced ability to work collaboratively in a high-paced team environment, meet deadlines, and prioritize work from multiple projects
- Excellent organizational and critical thinking skills
- Advanced problem-solving ability/mentality, technically adept and logical
- Advanced ability to communicate effectively with peers, department management, and cross functional peers
- Proficient with Excel, Visio, PowerPoint, and other common software applications
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Additional Requirements
- Ability to work around biohazardous materials
Locations
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
120,000 - 180,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Experience with various bioanalytical techniques (cell-based assays, ELISA, qPCR, flow cytometry) and associated equipmentintermediate
- Ability to work in a highly regulated environment and follow regulatory requirements and GMPsintermediate
- Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environmentintermediate
- Advanced ability to work collaboratively in a high-paced team environment, meet deadlines, and prioritize work from multiple projectsintermediate
- Excellent organizational and critical thinking skillsintermediate
- Advanced problem-solving ability/mentality, technically adept and logicalintermediate
- Advanced ability to communicate effectively with peers, department management, and cross functional peersintermediate
- Proficient with Excel, Visio, PowerPoint, and other common software applicationsintermediate
Required Qualifications
- Bachelor's degree, preferably in Chemistry, Microbiology or related science (experience)
- + years of relevant laboratory work experience, preferably in a regulated environment (experience)
- + years of management and people leader experience (experience)
Preferred Qualifications
- Experience with laboratory LIMS, ELN, and ERP systems (e.g., SAP) (experience)
Responsibilities
- Supervise the QC Analytical lab staff on shift and oversee daily lab activities related to in-process, final release, and stability testing of cell therapy drug product
- Develop and execute a work plan for the shift, ensuring safety, quality, and performance targets are achieved
- Perform QC data review ensuring results are compliant with specifications and regulations
- Report abnormalities
- Track, trend, and report key performance metrics
- Drive continuous improvement in the lab to increase productivity and efficiency
- Collaborate with other departments to identify and implement process improvements
- Review and approve test methods and procedures to ensure operational alignment and compliance with corporate policies and procedures
- Own and evaluate relevant change controls, investigations, deviations, CAPAs
- Hire, mentor, and develop team members to support the business operations and employee career development
- Oversee training of the team members
- Communicate effectively with management regarding task completion, roadblocks, and needs
- Responsible for cGMP compliance in all aspects of laboratory operations
- Participate in site team supporting and managing regulatory inspections and findings
- Perform other tasks as assigned
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
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QC Analytical Manager, Molecular, Cell Therapy in Devens, MA
Bristol-Myers Squibb
QC Analytical Manager, Molecular, Cell Therapy in Devens, MA
Job Description
Supervise the QC Analytical lab staff on shift and oversee the daily lab activities related to in-process, final release, and stability testing of cell therapy drug product. Develop and execute a work plan for the shift, ensuring safety, quality, and performance targets are achieved. Perform QC data review ensuring results are compliant with specifications and regulations. Report abnormalities. Track, trend, and report key performance metrics. Drive continuous improvement in the lab to increase productivity and efficiency. May collaborate with other departments to identify and implement process improvements. Review and approve test methods and procedures to ensure operational alignment and compliance with corporate policies and procedures. Own and evaluate relevant change controls, investigations, deviations, CAPAs. Hire, mentor, and develop team members to support the business operations and employee career development. Oversee training of the team members. Communicate effectively with management regarding task completion, roadblocks, and needs. Responsible for cGMP compliance in all aspects of laboratory operations. Participate in site team supporting and managing regulatory inspections and findings. Perform other tasks as assigned. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Supporting People with Disabilities Experience with various bioanalytical techniques (cell-based assays, ELISA, qPCR, flow cytometry) and associated equipment. Experience with laboratory LIMS, ELN, and ERP systems (e.g., SAP) preferred. Ability to work in a highly regulated environment and follow regulatory requirements and GMPs. Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environment. Advanced ability to work collaboratively in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. Excellent organizational and critical thinking skills. Advanced problem-solving ability/mentality, technically adept and logical. Advanced ability to communicate effectively with peers, department management, and cross functional peers. Proficient with Excel, Visio, PowerPoint, and other common software applications. The incumbent will be working around biohazardous materials. Bachelor's degree required, preferably in Chemistry, Microbiology or related science. 6+ years of relevant laboratory work experience, preferably in a regulated environment. 2+ years of management and people leader experience. An equivalent combination of education and experience may substitute.
About the Role/Company
- The company supports people with disabilities
Key Responsibilities
- Supervise the QC Analytical lab staff on shift and oversee daily lab activities related to in-process, final release, and stability testing of cell therapy drug product
- Develop and execute a work plan for the shift, ensuring safety, quality, and performance targets are achieved
- Perform QC data review ensuring results are compliant with specifications and regulations
- Report abnormalities
- Track, trend, and report key performance metrics
- Drive continuous improvement in the lab to increase productivity and efficiency
- Collaborate with other departments to identify and implement process improvements
- Review and approve test methods and procedures to ensure operational alignment and compliance with corporate policies and procedures
- Own and evaluate relevant change controls, investigations, deviations, CAPAs
- Hire, mentor, and develop team members to support the business operations and employee career development
- Oversee training of the team members
- Communicate effectively with management regarding task completion, roadblocks, and needs
- Responsible for cGMP compliance in all aspects of laboratory operations
- Participate in site team supporting and managing regulatory inspections and findings
- Perform other tasks as assigned
Required Qualifications
- Bachelor's degree, preferably in Chemistry, Microbiology or related science
- + years of relevant laboratory work experience, preferably in a regulated environment
- + years of management and people leader experience
Preferred Qualifications
- Experience with laboratory LIMS, ELN, and ERP systems (e.g., SAP)
Skills Required
- Experience with various bioanalytical techniques (cell-based assays, ELISA, qPCR, flow cytometry) and associated equipment
- Ability to work in a highly regulated environment and follow regulatory requirements and GMPs
- Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environment
- Advanced ability to work collaboratively in a high-paced team environment, meet deadlines, and prioritize work from multiple projects
- Excellent organizational and critical thinking skills
- Advanced problem-solving ability/mentality, technically adept and logical
- Advanced ability to communicate effectively with peers, department management, and cross functional peers
- Proficient with Excel, Visio, PowerPoint, and other common software applications
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Additional Requirements
- Ability to work around biohazardous materials
Locations
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
120,000 - 180,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Experience with various bioanalytical techniques (cell-based assays, ELISA, qPCR, flow cytometry) and associated equipmentintermediate
- Ability to work in a highly regulated environment and follow regulatory requirements and GMPsintermediate
- Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environmentintermediate
- Advanced ability to work collaboratively in a high-paced team environment, meet deadlines, and prioritize work from multiple projectsintermediate
- Excellent organizational and critical thinking skillsintermediate
- Advanced problem-solving ability/mentality, technically adept and logicalintermediate
- Advanced ability to communicate effectively with peers, department management, and cross functional peersintermediate
- Proficient with Excel, Visio, PowerPoint, and other common software applicationsintermediate
Required Qualifications
- Bachelor's degree, preferably in Chemistry, Microbiology or related science (experience)
- + years of relevant laboratory work experience, preferably in a regulated environment (experience)
- + years of management and people leader experience (experience)
Preferred Qualifications
- Experience with laboratory LIMS, ELN, and ERP systems (e.g., SAP) (experience)
Responsibilities
- Supervise the QC Analytical lab staff on shift and oversee daily lab activities related to in-process, final release, and stability testing of cell therapy drug product
- Develop and execute a work plan for the shift, ensuring safety, quality, and performance targets are achieved
- Perform QC data review ensuring results are compliant with specifications and regulations
- Report abnormalities
- Track, trend, and report key performance metrics
- Drive continuous improvement in the lab to increase productivity and efficiency
- Collaborate with other departments to identify and implement process improvements
- Review and approve test methods and procedures to ensure operational alignment and compliance with corporate policies and procedures
- Own and evaluate relevant change controls, investigations, deviations, CAPAs
- Hire, mentor, and develop team members to support the business operations and employee career development
- Oversee training of the team members
- Communicate effectively with management regarding task completion, roadblocks, and needs
- Responsible for cGMP compliance in all aspects of laboratory operations
- Participate in site team supporting and managing regulatory inspections and findings
- Perform other tasks as assigned
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for QC Analytical Manager, Molecular, Cell Therapy in Devens, MA @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs