NIGHT SHIFT: Manager, Cell Therapy Manufacturing in Devens, MA
Bristol-Myers Squibb
NIGHT SHIFT: Manager, Cell Therapy Manufacturing in Devens, MA
Job Description
Manage the creation, implementation and compliance for all documentation, procedures and policies Operate within the requirements of a validated manufacturing systems, plan, assign and oversee daily operational activities associated with assigned areas of responsibility. Maintain operating and storage areas that are compliant, efficient, effective and safe. Identify strategic and operational issues to prevent deviations and maintain a compliant environment. Lead and manage the development of corrective and preventative actions, deviation responses and investigations. Manage implementation and maintenance of appropriate training curricula Create an environment of teamwork, open communication, and a sense of urgency. Foster a culture of safety and compliance that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements. Efficiently coordinate, communicate, and provide Operations project information and activities status to Planning, Manufacturing, Quality Assurance / Operations, Global Supply and other associated functions in a timely manner in accordance to schedules and defined implementation timelines Perform unit operations and support operations described in standard operating procedures and batch records in a safe and GMP compliant manner. Assist in the setup of manufacturing areas and equipment/fixtures and perform facility and equipment commissioning, qualification and validation activities. 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. Advanced ability to accurately and completely understand, follow, interpret and apply global regulatory and cGMP requirements. Demonstrated advanced technical writing skills. Advanced strategic thinking and problem-solving ability/mentality, technically adept and logical. Ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects. Advanced ability to communicate and collaborate effectively with peers, senior management and cross-functional peers about task status, roadblocks and needs, locally and globally. Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills. Bachelors in relevant science or engineering discipline, or equivalent in work experience. 5+ years of experience in cGMP biologics cell culture manufacturing Cell therapy manufacturing Aseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human derived materials in BSL-2 containment areas. Cell expansion using incubators and single use bioreactors, Cell washing processes, Cell separation techniques and cryopreservation processes and equipment.
Key Responsibilities
- Manage the creation, implementation, and compliance for all documentation, procedures, and policies
- Operate within the requirements of validated manufacturing systems
- Plan, assign, and oversee daily operational activities associated with assigned areas of responsibility
- Maintain operating and storage areas that are compliant, efficient, effective, and safe
- Identify strategic and operational issues to prevent deviations and maintain a compliant environment
- Lead and manage the development of corrective and preventative actions, deviation responses, and investigations
- Manage implementation and maintenance of appropriate training curricula
- Create an environment of teamwork, open communication, and a sense of urgency
- Foster a culture of safety and compliance that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements
- Efficiently coordinate, communicate, and provide Operations project information and activities status to Planning, Manufacturing, Quality Assurance/Operations, Global Supply, and other associated functions in a timely manner in accordance with schedules and defined implementation timelines
- Perform unit operations and support operations described in standard operating procedures and batch records in a safe and GMP compliant manner
- Assist in the setup of manufacturing areas and equipment/fixtures and perform facility and equipment commissioning, qualification, and validation activities
Required Qualifications
- Bachelor's degree in a relevant science or engineering discipline, or equivalent work experience
- + years of experience in cGMP biologics cell culture manufacturing
- Experience in cell therapy manufacturing
- Experience with aseptic processing in ISO 5 biosafety cabinets
- Experience with universal precautions for handling human-derived materials in BSL-2 containment areas
- Experience with cell expansion using incubators and single-use bioreactors
- Experience with cell washing processes
- Experience with cell separation techniques
- Experience with cryopreservation processes and equipment
Skills Required
- Advanced ability to accurately and completely understand, follow, interpret, and apply global regulatory and cGMP requirements
- Demonstrated advanced technical writing skills
- Advanced strategic thinking and problem-solving ability/mentality, technically adept and logical
- Ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects
- Advanced ability to communicate and collaborate effectively with peers, senior management, and cross-functional peers about task status, roadblocks, and needs, locally and globally
- Advanced mentoring, coaching, influencing, negotiating, and personnel interaction skills
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
- Night shift work schedule
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
- Advanced ability to accurately and completely understand, follow, interpret, and apply global regulatory and cGMP requirementsintermediate
- Demonstrated advanced technical writing skillsintermediate
- Advanced strategic thinking and problem-solving ability/mentality, technically adept and logicalintermediate
- Ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projectsintermediate
- Advanced ability to communicate and collaborate effectively with peers, senior management, and cross-functional peers about task status, roadblocks, and needs, locally and globallyintermediate
- Advanced mentoring, coaching, influencing, negotiating, and personnel interaction skillsintermediate
Required Qualifications
- Bachelor's degree in a relevant science or engineering discipline, or equivalent work experience (experience)
- + years of experience in cGMP biologics cell culture manufacturing (experience)
- Experience in cell therapy manufacturing (experience)
- Experience with aseptic processing in ISO 5 biosafety cabinets (experience)
- Experience with universal precautions for handling human-derived materials in BSL-2 containment areas (experience)
- Experience with cell expansion using incubators and single-use bioreactors (experience)
- Experience with cell washing processes (experience)
- Experience with cell separation techniques (experience)
- Experience with cryopreservation processes and equipment (experience)
Responsibilities
- Manage the creation, implementation, and compliance for all documentation, procedures, and policies
- Operate within the requirements of validated manufacturing systems
- Plan, assign, and oversee daily operational activities associated with assigned areas of responsibility
- Maintain operating and storage areas that are compliant, efficient, effective, and safe
- Identify strategic and operational issues to prevent deviations and maintain a compliant environment
- Lead and manage the development of corrective and preventative actions, deviation responses, and investigations
- Manage implementation and maintenance of appropriate training curricula
- Create an environment of teamwork, open communication, and a sense of urgency
- Foster a culture of safety and compliance that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements
- Efficiently coordinate, communicate, and provide Operations project information and activities status to Planning, Manufacturing, Quality Assurance/Operations, Global Supply, and other associated functions in a timely manner in accordance with schedules and defined implementation timelines
- Perform unit operations and support operations described in standard operating procedures and batch records in a safe and GMP compliant manner
- Assist in the setup of manufacturing areas and equipment/fixtures and perform facility and equipment commissioning, qualification, and validation activities
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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Answer 10 quick questions to check your fit for NIGHT SHIFT: Manager, Cell Therapy Manufacturing in Devens, MA @ Bristol-Myers Squibb.
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NIGHT SHIFT: Manager, Cell Therapy Manufacturing in Devens, MA
Bristol-Myers Squibb
NIGHT SHIFT: Manager, Cell Therapy Manufacturing in Devens, MA
Job Description
Manage the creation, implementation and compliance for all documentation, procedures and policies Operate within the requirements of a validated manufacturing systems, plan, assign and oversee daily operational activities associated with assigned areas of responsibility. Maintain operating and storage areas that are compliant, efficient, effective and safe. Identify strategic and operational issues to prevent deviations and maintain a compliant environment. Lead and manage the development of corrective and preventative actions, deviation responses and investigations. Manage implementation and maintenance of appropriate training curricula Create an environment of teamwork, open communication, and a sense of urgency. Foster a culture of safety and compliance that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements. Efficiently coordinate, communicate, and provide Operations project information and activities status to Planning, Manufacturing, Quality Assurance / Operations, Global Supply and other associated functions in a timely manner in accordance to schedules and defined implementation timelines Perform unit operations and support operations described in standard operating procedures and batch records in a safe and GMP compliant manner. Assist in the setup of manufacturing areas and equipment/fixtures and perform facility and equipment commissioning, qualification and validation activities. 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. Advanced ability to accurately and completely understand, follow, interpret and apply global regulatory and cGMP requirements. Demonstrated advanced technical writing skills. Advanced strategic thinking and problem-solving ability/mentality, technically adept and logical. Ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects. Advanced ability to communicate and collaborate effectively with peers, senior management and cross-functional peers about task status, roadblocks and needs, locally and globally. Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills. Bachelors in relevant science or engineering discipline, or equivalent in work experience. 5+ years of experience in cGMP biologics cell culture manufacturing Cell therapy manufacturing Aseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human derived materials in BSL-2 containment areas. Cell expansion using incubators and single use bioreactors, Cell washing processes, Cell separation techniques and cryopreservation processes and equipment.
Key Responsibilities
- Manage the creation, implementation, and compliance for all documentation, procedures, and policies
- Operate within the requirements of validated manufacturing systems
- Plan, assign, and oversee daily operational activities associated with assigned areas of responsibility
- Maintain operating and storage areas that are compliant, efficient, effective, and safe
- Identify strategic and operational issues to prevent deviations and maintain a compliant environment
- Lead and manage the development of corrective and preventative actions, deviation responses, and investigations
- Manage implementation and maintenance of appropriate training curricula
- Create an environment of teamwork, open communication, and a sense of urgency
- Foster a culture of safety and compliance that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements
- Efficiently coordinate, communicate, and provide Operations project information and activities status to Planning, Manufacturing, Quality Assurance/Operations, Global Supply, and other associated functions in a timely manner in accordance with schedules and defined implementation timelines
- Perform unit operations and support operations described in standard operating procedures and batch records in a safe and GMP compliant manner
- Assist in the setup of manufacturing areas and equipment/fixtures and perform facility and equipment commissioning, qualification, and validation activities
Required Qualifications
- Bachelor's degree in a relevant science or engineering discipline, or equivalent work experience
- + years of experience in cGMP biologics cell culture manufacturing
- Experience in cell therapy manufacturing
- Experience with aseptic processing in ISO 5 biosafety cabinets
- Experience with universal precautions for handling human-derived materials in BSL-2 containment areas
- Experience with cell expansion using incubators and single-use bioreactors
- Experience with cell washing processes
- Experience with cell separation techniques
- Experience with cryopreservation processes and equipment
Skills Required
- Advanced ability to accurately and completely understand, follow, interpret, and apply global regulatory and cGMP requirements
- Demonstrated advanced technical writing skills
- Advanced strategic thinking and problem-solving ability/mentality, technically adept and logical
- Ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects
- Advanced ability to communicate and collaborate effectively with peers, senior management, and cross-functional peers about task status, roadblocks, and needs, locally and globally
- Advanced mentoring, coaching, influencing, negotiating, and personnel interaction skills
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
- Night shift work schedule
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
- Advanced ability to accurately and completely understand, follow, interpret, and apply global regulatory and cGMP requirementsintermediate
- Demonstrated advanced technical writing skillsintermediate
- Advanced strategic thinking and problem-solving ability/mentality, technically adept and logicalintermediate
- Ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projectsintermediate
- Advanced ability to communicate and collaborate effectively with peers, senior management, and cross-functional peers about task status, roadblocks, and needs, locally and globallyintermediate
- Advanced mentoring, coaching, influencing, negotiating, and personnel interaction skillsintermediate
Required Qualifications
- Bachelor's degree in a relevant science or engineering discipline, or equivalent work experience (experience)
- + years of experience in cGMP biologics cell culture manufacturing (experience)
- Experience in cell therapy manufacturing (experience)
- Experience with aseptic processing in ISO 5 biosafety cabinets (experience)
- Experience with universal precautions for handling human-derived materials in BSL-2 containment areas (experience)
- Experience with cell expansion using incubators and single-use bioreactors (experience)
- Experience with cell washing processes (experience)
- Experience with cell separation techniques (experience)
- Experience with cryopreservation processes and equipment (experience)
Responsibilities
- Manage the creation, implementation, and compliance for all documentation, procedures, and policies
- Operate within the requirements of validated manufacturing systems
- Plan, assign, and oversee daily operational activities associated with assigned areas of responsibility
- Maintain operating and storage areas that are compliant, efficient, effective, and safe
- Identify strategic and operational issues to prevent deviations and maintain a compliant environment
- Lead and manage the development of corrective and preventative actions, deviation responses, and investigations
- Manage implementation and maintenance of appropriate training curricula
- Create an environment of teamwork, open communication, and a sense of urgency
- Foster a culture of safety and compliance that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements
- Efficiently coordinate, communicate, and provide Operations project information and activities status to Planning, Manufacturing, Quality Assurance/Operations, Global Supply, and other associated functions in a timely manner in accordance with schedules and defined implementation timelines
- Perform unit operations and support operations described in standard operating procedures and batch records in a safe and GMP compliant manner
- Assist in the setup of manufacturing areas and equipment/fixtures and perform facility and equipment commissioning, qualification, and validation activities
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 NIGHT SHIFT: Manager, Cell Therapy Manufacturing in Devens, MA @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs