Specialist, Lead Manufacturing Associate, Cell Therapy Value Stream CAR-T Manufacturing
Bristol-Myers Squibb
Specialist, Lead Manufacturing Associate, Cell Therapy Value Stream CAR-T Manufacturing
Job Description
Execute operations described in Standard Operating Procedures (SOPs) and batch records Executes transactions and process in all electronic systems Demonstrate a strong practical and theoretical knowledge in their work Complete documentation required by governing controlled documents and batch records. Ensure that all documentation produced by their team is right first time. Solve complex problems; takes new perspectives using existing solutions Easily approachable and maintains a desire to build and foster relationships while working through challenges/opportunities. Perform tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements Evaluate team processing performance and communicate delays to leadership. Takes a proactive approach in resolving issues / bottlenecks. Complete training assignments to ensure the necessary technical skills and knowledge Proficient in process systems and supporting business systems Provide assistance setting up manufacturing areas and equipment/fixtures, as needed Collaborate with support groups on recommendations and solving technical problems. Ensure the shift works effectively in a team based, cross-functional environment to complete all production tasks required by shift schedule Collaborate closely with Shift Supervisors/Managers to ensure seamless pass down and communication of operational status Initiates deviations and supports investigations / CAPA development Qualified as a deviation investigator and completes assigned investigations timely Completes change actions for change controls or investigations Initiates and facilitates triage calls, provides support to Management as needed Identify and propose innovative solutions Support writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements Trains and qualifies others on SOPs, Work Instructions to successfully complete manufacturing operations Support production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts as needed Drive right first time (RFT) execution of manufacturing unit operations by providing direct training, guidance, and problem solving Aid in daily work coordination and distribution as demanded through the production schedule Maintain schedule adherence and cycle time. Report variances and communicate impact to cross functional groups and managers Provide shift handover, as needed Ensure shift notes communication is complete and accurate, as needed Provide daily update summary to functional group for SQDCP, as needed 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 Cross-trained into multiple processes (as assigned) as operator / verifier Leads cross-functional projects and ensure timelines and deliverables are adhered to Attends Leadership Development training as development opportunity for career path as a future people leader Shadows manager(s) on leadership tasks in preparation for potential future responsibilities (including but not limited to, preparing production schedule, running team meetings, providing technical feedback to colleagues, giving recognition when deserved) Work in areas that may have strong magnets. Work in areas with exposure to vapor phase liquid nitrogen. 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. Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence is highly desired. Demonstrated aptitude for engineering principles and manufacturing systems. Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications. Demonstrated good interpersonal skills, is attentive and approachable. Maintain a professional and productive relationship with area management and co-workers. Pre-requisites: Senior Associate in Manufacturing. Bachelor's degree and 4 years of experience in cell therapy in Biopharmaceutical operations. Or Associate / Medical Technical degree and 6+ years of Manufacturing Operations experience. Or High School diploma/GED and 8+ years of Manufacturing or Operations experience. 1 year of training experience within the pharmaceutical industry. 1 year of trouble-shooting technical issues on the manufacturing floor. Extensive knowledge of cGMP regulations and FDA guidance applicable to cell therapy manufacturing. Experience in cell therapy manufacturing, including Cell washing processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment. Cell expansion using incubators and single use bioreactors .
About the Role/Company
- The company offers work-life programs to support employees
- The company values leadership development and provides training opportunities for future people leaders
Key Responsibilities
- Execute operations described in Standard Operating Procedures (SOPs) and batch records
- Execute transactions and processes in all electronic systems
- Demonstrate strong practical and theoretical knowledge in work
- Complete documentation required by governing controlled documents and batch records
- Ensure all documentation produced by team is right first time
- Solve complex problems; take new perspectives using existing solutions
- Be easily approachable and maintain a desire to build and foster relationships while working through challenges/opportunities
- Perform tasks in a manner consistent with safety policies, SOPs, quality systems, and GMP requirements
- Evaluate team processing performance and communicate delays to leadership
- Take a proactive approach in resolving issues / bottlenecks
- Complete training assignments to ensure necessary technical skills and knowledge
- Be proficient in process systems and supporting business systems
- Provide assistance setting up manufacturing areas and equipment/fixtures, as needed
- Collaborate with support groups on recommendations and solving technical problems
- Ensure shift works effectively in a team-based, cross-functional environment to complete all production tasks required by shift schedule
- Collaborate closely with Shift Supervisors/Managers to ensure seamless pass down and communication of operational status
- Initiate deviations and support investigations / CAPA development
- Be qualified as a deviation investigator and complete assigned investigations timely
- Complete change actions for change controls or investigations
- Initiate and facilitate triage calls, provide support to Management as needed
- Identify and propose innovative solutions
- Support writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
- Train and qualify others on SOPs, Work Instructions to successfully complete manufacturing operations
- Support production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts as needed
- Drive right first time (RFT) execution of manufacturing unit operations by providing direct training, guidance, and problem solving
- Aid in daily work coordination and distribution as demanded through the production schedule
- Maintain schedule adherence and cycle time
- Report variances and communicate impact to cross functional groups and managers
- Provide shift handover, as needed
- Ensure shift notes communication is complete and accurate, as needed
- Provide daily update summary to functional group for SQDCP, as needed
- Maintain manufacturing environmental conditions by performing area disinfection regiment as required to meet global Health Authority requirements
- Be cross-trained into multiple processes as operator / verifier
- Lead cross-functional projects and ensure timelines and deliverables are adhered to
- Attend Leadership Development training as development opportunity for career path as a future people leader
- Shadow manager(s) on leadership tasks in preparation for potential future responsibilities
Required Qualifications
- Bachelor's degree and 4 years of experience in cell therapy in Biopharmaceutical operations
- Associate / Medical Technical degree and 6+ years of Manufacturing Operations experience
- High School diploma/GED and 8+ years of Manufacturing or Operations experience
- year of training experience within the pharmaceutical industry
- year of trouble-shooting technical issues on the manufacturing floor
- Extensive knowledge of cGMP regulations and FDA guidance applicable to cell therapy manufacturing
- Experience in cell therapy manufacturing, including Cell washing processes and automated equipment
- Cell separation techniques and automated equipment
- Cryopreservation processes and equipment
- Cell expansion using incubators and single use bioreactors
Preferred Qualifications
- Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence
- Demonstrated aptitude for engineering principles and manufacturing systems
- Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications
- Demonstrated good interpersonal skills, is attentive and approachable
Skills Required
- Strong practical and theoretical knowledge in work
- Ability to solve complex problems and take new perspectives using existing solutions
- Easily approachable with a desire to build and foster relationships
- Proficiency in process systems and supporting business systems
- Ability to collaborate effectively with support groups and cross-functional teams
- Qualified as a deviation investigator
- Ability to initiate and facilitate triage calls
- Proficiency in writing manufacturing operating procedures
- Ability to train and qualify others on SOPs and Work Instructions
- Ability to drive right first time (RFT) execution of manufacturing unit operations
- Proficiency in common computer tools such as word processing, spreadsheet and web-based applications
- Good interpersonal skills, attentive and approachable
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
- Work in areas that may have strong magnets
- Work in areas with exposure to vapor phase liquid nitrogen
Locations
- Summit West NJ, United States
Salary
Estimated Salary Rangemedium confidence
90,000 - 130,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong practical and theoretical knowledge in workintermediate
- Ability to solve complex problems and take new perspectives using existing solutionsintermediate
- Easily approachable with a desire to build and foster relationshipsintermediate
- Proficiency in process systems and supporting business systemsintermediate
- Ability to collaborate effectively with support groups and cross-functional teamsintermediate
- Qualified as a deviation investigatorintermediate
- Ability to initiate and facilitate triage callsintermediate
- Proficiency in writing manufacturing operating proceduresintermediate
- Ability to train and qualify others on SOPs and Work Instructionsintermediate
- Ability to drive right first time (RFT) execution of manufacturing unit operationsintermediate
- Proficiency in common computer tools such as word processing, spreadsheet and web-based applicationsintermediate
- Good interpersonal skills, attentive and approachableintermediate
Required Qualifications
- Bachelor's degree and 4 years of experience in cell therapy in Biopharmaceutical operations (experience)
- Associate / Medical Technical degree and 6+ years of Manufacturing Operations experience (experience)
- High School diploma/GED and 8+ years of Manufacturing or Operations experience (experience)
- year of training experience within the pharmaceutical industry (experience)
- year of trouble-shooting technical issues on the manufacturing floor (experience)
- Extensive knowledge of cGMP regulations and FDA guidance applicable to cell therapy manufacturing (experience)
- Experience in cell therapy manufacturing, including Cell washing processes and automated equipment (experience)
- Cell separation techniques and automated equipment (experience)
- Cryopreservation processes and equipment (experience)
- Cell expansion using incubators and single use bioreactors (experience)
Preferred Qualifications
- Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence (experience)
- Demonstrated aptitude for engineering principles and manufacturing systems (experience)
- Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications (experience)
- Demonstrated good interpersonal skills, is attentive and approachable (experience)
Responsibilities
- Execute operations described in Standard Operating Procedures (SOPs) and batch records
- Execute transactions and processes in all electronic systems
- Demonstrate strong practical and theoretical knowledge in work
- Complete documentation required by governing controlled documents and batch records
- Ensure all documentation produced by team is right first time
- Solve complex problems; take new perspectives using existing solutions
- Be easily approachable and maintain a desire to build and foster relationships while working through challenges/opportunities
- Perform tasks in a manner consistent with safety policies, SOPs, quality systems, and GMP requirements
- Evaluate team processing performance and communicate delays to leadership
- Take a proactive approach in resolving issues / bottlenecks
- Complete training assignments to ensure necessary technical skills and knowledge
- Be proficient in process systems and supporting business systems
- Provide assistance setting up manufacturing areas and equipment/fixtures, as needed
- Collaborate with support groups on recommendations and solving technical problems
- Ensure shift works effectively in a team-based, cross-functional environment to complete all production tasks required by shift schedule
- Collaborate closely with Shift Supervisors/Managers to ensure seamless pass down and communication of operational status
- Initiate deviations and support investigations / CAPA development
- Be qualified as a deviation investigator and complete assigned investigations timely
- Complete change actions for change controls or investigations
- Initiate and facilitate triage calls, provide support to Management as needed
- Identify and propose innovative solutions
- Support writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
- Train and qualify others on SOPs, Work Instructions to successfully complete manufacturing operations
- Support production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts as needed
- Drive right first time (RFT) execution of manufacturing unit operations by providing direct training, guidance, and problem solving
- Aid in daily work coordination and distribution as demanded through the production schedule
- Maintain schedule adherence and cycle time
- Report variances and communicate impact to cross functional groups and managers
- Provide shift handover, as needed
- Ensure shift notes communication is complete and accurate, as needed
- Provide daily update summary to functional group for SQDCP, as needed
- Maintain manufacturing environmental conditions by performing area disinfection regiment as required to meet global Health Authority requirements
- Be cross-trained into multiple processes as operator / verifier
- Lead cross-functional projects and ensure timelines and deliverables are adhered to
- Attend Leadership Development training as development opportunity for career path as a future people leader
- Shadow manager(s) on leadership tasks in preparation for potential future responsibilities
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
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Specialist, Lead Manufacturing Associate, Cell Therapy Value Stream CAR-T Manufacturing
Bristol-Myers Squibb
Specialist, Lead Manufacturing Associate, Cell Therapy Value Stream CAR-T Manufacturing
Job Description
Execute operations described in Standard Operating Procedures (SOPs) and batch records Executes transactions and process in all electronic systems Demonstrate a strong practical and theoretical knowledge in their work Complete documentation required by governing controlled documents and batch records. Ensure that all documentation produced by their team is right first time. Solve complex problems; takes new perspectives using existing solutions Easily approachable and maintains a desire to build and foster relationships while working through challenges/opportunities. Perform tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements Evaluate team processing performance and communicate delays to leadership. Takes a proactive approach in resolving issues / bottlenecks. Complete training assignments to ensure the necessary technical skills and knowledge Proficient in process systems and supporting business systems Provide assistance setting up manufacturing areas and equipment/fixtures, as needed Collaborate with support groups on recommendations and solving technical problems. Ensure the shift works effectively in a team based, cross-functional environment to complete all production tasks required by shift schedule Collaborate closely with Shift Supervisors/Managers to ensure seamless pass down and communication of operational status Initiates deviations and supports investigations / CAPA development Qualified as a deviation investigator and completes assigned investigations timely Completes change actions for change controls or investigations Initiates and facilitates triage calls, provides support to Management as needed Identify and propose innovative solutions Support writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements Trains and qualifies others on SOPs, Work Instructions to successfully complete manufacturing operations Support production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts as needed Drive right first time (RFT) execution of manufacturing unit operations by providing direct training, guidance, and problem solving Aid in daily work coordination and distribution as demanded through the production schedule Maintain schedule adherence and cycle time. Report variances and communicate impact to cross functional groups and managers Provide shift handover, as needed Ensure shift notes communication is complete and accurate, as needed Provide daily update summary to functional group for SQDCP, as needed 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 Cross-trained into multiple processes (as assigned) as operator / verifier Leads cross-functional projects and ensure timelines and deliverables are adhered to Attends Leadership Development training as development opportunity for career path as a future people leader Shadows manager(s) on leadership tasks in preparation for potential future responsibilities (including but not limited to, preparing production schedule, running team meetings, providing technical feedback to colleagues, giving recognition when deserved) Work in areas that may have strong magnets. Work in areas with exposure to vapor phase liquid nitrogen. 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. Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence is highly desired. Demonstrated aptitude for engineering principles and manufacturing systems. Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications. Demonstrated good interpersonal skills, is attentive and approachable. Maintain a professional and productive relationship with area management and co-workers. Pre-requisites: Senior Associate in Manufacturing. Bachelor's degree and 4 years of experience in cell therapy in Biopharmaceutical operations. Or Associate / Medical Technical degree and 6+ years of Manufacturing Operations experience. Or High School diploma/GED and 8+ years of Manufacturing or Operations experience. 1 year of training experience within the pharmaceutical industry. 1 year of trouble-shooting technical issues on the manufacturing floor. Extensive knowledge of cGMP regulations and FDA guidance applicable to cell therapy manufacturing. Experience in cell therapy manufacturing, including Cell washing processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment. Cell expansion using incubators and single use bioreactors .
About the Role/Company
- The company offers work-life programs to support employees
- The company values leadership development and provides training opportunities for future people leaders
Key Responsibilities
- Execute operations described in Standard Operating Procedures (SOPs) and batch records
- Execute transactions and processes in all electronic systems
- Demonstrate strong practical and theoretical knowledge in work
- Complete documentation required by governing controlled documents and batch records
- Ensure all documentation produced by team is right first time
- Solve complex problems; take new perspectives using existing solutions
- Be easily approachable and maintain a desire to build and foster relationships while working through challenges/opportunities
- Perform tasks in a manner consistent with safety policies, SOPs, quality systems, and GMP requirements
- Evaluate team processing performance and communicate delays to leadership
- Take a proactive approach in resolving issues / bottlenecks
- Complete training assignments to ensure necessary technical skills and knowledge
- Be proficient in process systems and supporting business systems
- Provide assistance setting up manufacturing areas and equipment/fixtures, as needed
- Collaborate with support groups on recommendations and solving technical problems
- Ensure shift works effectively in a team-based, cross-functional environment to complete all production tasks required by shift schedule
- Collaborate closely with Shift Supervisors/Managers to ensure seamless pass down and communication of operational status
- Initiate deviations and support investigations / CAPA development
- Be qualified as a deviation investigator and complete assigned investigations timely
- Complete change actions for change controls or investigations
- Initiate and facilitate triage calls, provide support to Management as needed
- Identify and propose innovative solutions
- Support writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
- Train and qualify others on SOPs, Work Instructions to successfully complete manufacturing operations
- Support production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts as needed
- Drive right first time (RFT) execution of manufacturing unit operations by providing direct training, guidance, and problem solving
- Aid in daily work coordination and distribution as demanded through the production schedule
- Maintain schedule adherence and cycle time
- Report variances and communicate impact to cross functional groups and managers
- Provide shift handover, as needed
- Ensure shift notes communication is complete and accurate, as needed
- Provide daily update summary to functional group for SQDCP, as needed
- Maintain manufacturing environmental conditions by performing area disinfection regiment as required to meet global Health Authority requirements
- Be cross-trained into multiple processes as operator / verifier
- Lead cross-functional projects and ensure timelines and deliverables are adhered to
- Attend Leadership Development training as development opportunity for career path as a future people leader
- Shadow manager(s) on leadership tasks in preparation for potential future responsibilities
Required Qualifications
- Bachelor's degree and 4 years of experience in cell therapy in Biopharmaceutical operations
- Associate / Medical Technical degree and 6+ years of Manufacturing Operations experience
- High School diploma/GED and 8+ years of Manufacturing or Operations experience
- year of training experience within the pharmaceutical industry
- year of trouble-shooting technical issues on the manufacturing floor
- Extensive knowledge of cGMP regulations and FDA guidance applicable to cell therapy manufacturing
- Experience in cell therapy manufacturing, including Cell washing processes and automated equipment
- Cell separation techniques and automated equipment
- Cryopreservation processes and equipment
- Cell expansion using incubators and single use bioreactors
Preferred Qualifications
- Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence
- Demonstrated aptitude for engineering principles and manufacturing systems
- Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications
- Demonstrated good interpersonal skills, is attentive and approachable
Skills Required
- Strong practical and theoretical knowledge in work
- Ability to solve complex problems and take new perspectives using existing solutions
- Easily approachable with a desire to build and foster relationships
- Proficiency in process systems and supporting business systems
- Ability to collaborate effectively with support groups and cross-functional teams
- Qualified as a deviation investigator
- Ability to initiate and facilitate triage calls
- Proficiency in writing manufacturing operating procedures
- Ability to train and qualify others on SOPs and Work Instructions
- Ability to drive right first time (RFT) execution of manufacturing unit operations
- Proficiency in common computer tools such as word processing, spreadsheet and web-based applications
- Good interpersonal skills, attentive and approachable
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
- Work in areas that may have strong magnets
- Work in areas with exposure to vapor phase liquid nitrogen
Locations
- Summit West NJ, United States
Salary
Estimated Salary Rangemedium confidence
90,000 - 130,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong practical and theoretical knowledge in workintermediate
- Ability to solve complex problems and take new perspectives using existing solutionsintermediate
- Easily approachable with a desire to build and foster relationshipsintermediate
- Proficiency in process systems and supporting business systemsintermediate
- Ability to collaborate effectively with support groups and cross-functional teamsintermediate
- Qualified as a deviation investigatorintermediate
- Ability to initiate and facilitate triage callsintermediate
- Proficiency in writing manufacturing operating proceduresintermediate
- Ability to train and qualify others on SOPs and Work Instructionsintermediate
- Ability to drive right first time (RFT) execution of manufacturing unit operationsintermediate
- Proficiency in common computer tools such as word processing, spreadsheet and web-based applicationsintermediate
- Good interpersonal skills, attentive and approachableintermediate
Required Qualifications
- Bachelor's degree and 4 years of experience in cell therapy in Biopharmaceutical operations (experience)
- Associate / Medical Technical degree and 6+ years of Manufacturing Operations experience (experience)
- High School diploma/GED and 8+ years of Manufacturing or Operations experience (experience)
- year of training experience within the pharmaceutical industry (experience)
- year of trouble-shooting technical issues on the manufacturing floor (experience)
- Extensive knowledge of cGMP regulations and FDA guidance applicable to cell therapy manufacturing (experience)
- Experience in cell therapy manufacturing, including Cell washing processes and automated equipment (experience)
- Cell separation techniques and automated equipment (experience)
- Cryopreservation processes and equipment (experience)
- Cell expansion using incubators and single use bioreactors (experience)
Preferred Qualifications
- Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence (experience)
- Demonstrated aptitude for engineering principles and manufacturing systems (experience)
- Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications (experience)
- Demonstrated good interpersonal skills, is attentive and approachable (experience)
Responsibilities
- Execute operations described in Standard Operating Procedures (SOPs) and batch records
- Execute transactions and processes in all electronic systems
- Demonstrate strong practical and theoretical knowledge in work
- Complete documentation required by governing controlled documents and batch records
- Ensure all documentation produced by team is right first time
- Solve complex problems; take new perspectives using existing solutions
- Be easily approachable and maintain a desire to build and foster relationships while working through challenges/opportunities
- Perform tasks in a manner consistent with safety policies, SOPs, quality systems, and GMP requirements
- Evaluate team processing performance and communicate delays to leadership
- Take a proactive approach in resolving issues / bottlenecks
- Complete training assignments to ensure necessary technical skills and knowledge
- Be proficient in process systems and supporting business systems
- Provide assistance setting up manufacturing areas and equipment/fixtures, as needed
- Collaborate with support groups on recommendations and solving technical problems
- Ensure shift works effectively in a team-based, cross-functional environment to complete all production tasks required by shift schedule
- Collaborate closely with Shift Supervisors/Managers to ensure seamless pass down and communication of operational status
- Initiate deviations and support investigations / CAPA development
- Be qualified as a deviation investigator and complete assigned investigations timely
- Complete change actions for change controls or investigations
- Initiate and facilitate triage calls, provide support to Management as needed
- Identify and propose innovative solutions
- Support writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
- Train and qualify others on SOPs, Work Instructions to successfully complete manufacturing operations
- Support production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts as needed
- Drive right first time (RFT) execution of manufacturing unit operations by providing direct training, guidance, and problem solving
- Aid in daily work coordination and distribution as demanded through the production schedule
- Maintain schedule adherence and cycle time
- Report variances and communicate impact to cross functional groups and managers
- Provide shift handover, as needed
- Ensure shift notes communication is complete and accurate, as needed
- Provide daily update summary to functional group for SQDCP, as needed
- Maintain manufacturing environmental conditions by performing area disinfection regiment as required to meet global Health Authority requirements
- Be cross-trained into multiple processes as operator / verifier
- Lead cross-functional projects and ensure timelines and deliverables are adhered to
- Attend Leadership Development training as development opportunity for career path as a future people leader
- Shadow manager(s) on leadership tasks in preparation for potential future responsibilities
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 Specialist, Lead Manufacturing Associate, Cell Therapy Value Stream CAR-T Manufacturing @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs