Associate II Manufacturing, Cell Therapy
Bristol-Myers Squibb
Associate II Manufacturing, Cell Therapy
Job Description
Learn and execute Cell Therapy Manufacturing operations Perform patient process unit operations and support operations described in standard operating procedures and batch records Executes transactions and process in all electronic systems Prioritizes safety of self and others Reports safety events within 24 hours Escalates any/all issues that may impact safety of self and/or others. Complete documentation required by governing controlled documents and batch records Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements Complete training assignments to ensure the necessary technical skills and knowledge Trains for proficiency in process systems and some supporting business systems Execute daily unit operations schedule, that includes people, product, and material flow across multiple shifts Work within a controlled cleanroom environment and execute aseptic processing procedures (as assigned). 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 Continues to refine and improve manufacturing process technique to improve individual operational times. Ensures training completion prior to production Demonstrate strong practical and theoretical knowledge Collaborate with support groups on recommendations and solving technical and operational problems Train others on SOPs and Work Instructions to successfully complete manufacturing operations. Associate or bachelor's degree in related field is preferred. A minimum high school diploma and/or equivalent combination of education and experience is required. MBO 3 of 4 in science related field and/or equivalent Experience: 1+ years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education Extensive knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing 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 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
Key Responsibilities
- Learn and execute Cell Therapy Manufacturing operations
- Perform patient process unit operations and support operations described in standard operating procedures and batch records
- Executes transactions and process in all electronic systems
- Prioritizes safety of self and others
- Reports safety events within 24 hours
- Escalates any/all issues that may impact safety of self and/or others
- Complete documentation required by governing controlled documents and batch records
- Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements
- Complete training assignments to ensure the necessary technical skills and knowledge
- Trains for proficiency in process systems and some supporting business systems
- Execute daily unit operations schedule, that includes people, product, and material flow across multiple shifts
- Work within a controlled cleanroom environment and execute aseptic processing procedures (as assigned)
- 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
- Continues to refine and improve manufacturing process technique to improve individual operational times
- Ensures training completion prior to production
- Demonstrate strong practical and theoretical knowledge
- Collaborate with support groups on recommendations and solving technical and operational problems
- Train others on SOPs and Work Instructions to successfully complete manufacturing operations
Required Qualifications
- A minimum high school diploma and/or equivalent combination of education and experience
- MBO 3 of 4 in science related field and/or equivalent
- + years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education
Preferred Qualifications
- Associate or bachelor's degree in related field
- Extensive knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
- Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence
- Demonstrated aptitude for engineering principles and manufacturing systems
- 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
Skills Required
- 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
Locations
- Leiden – NL, United States
Salary
Estimated Salary Rangemedium confidence
60,000 - 90,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applicationsintermediate
- Demonstrated good interpersonal skills, is attentive and approachableintermediate
- Maintain a professional and productive relationship with area management and co-workersintermediate
Required Qualifications
- A minimum high school diploma and/or equivalent combination of education and experience (experience)
- MBO 3 of 4 in science related field and/or equivalent (experience)
- + years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education (experience)
Preferred Qualifications
- Associate or bachelor's degree in related field (experience)
- Extensive knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing (experience)
- Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence (experience)
- Demonstrated aptitude for engineering principles and manufacturing systems (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)
Responsibilities
- Learn and execute Cell Therapy Manufacturing operations
- Perform patient process unit operations and support operations described in standard operating procedures and batch records
- Executes transactions and process in all electronic systems
- Prioritizes safety of self and others
- Reports safety events within 24 hours
- Escalates any/all issues that may impact safety of self and/or others
- Complete documentation required by governing controlled documents and batch records
- Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements
- Complete training assignments to ensure the necessary technical skills and knowledge
- Trains for proficiency in process systems and some supporting business systems
- Execute daily unit operations schedule, that includes people, product, and material flow across multiple shifts
- Work within a controlled cleanroom environment and execute aseptic processing procedures (as assigned)
- 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
- Continues to refine and improve manufacturing process technique to improve individual operational times
- Ensures training completion prior to production
- Demonstrate strong practical and theoretical knowledge
- Collaborate with support groups on recommendations and solving technical and operational problems
- Train others on SOPs and Work Instructions to successfully complete manufacturing operations
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Answer 10 quick questions to check your fit for Associate II Manufacturing, Cell Therapy @ Bristol-Myers Squibb.
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Associate II Manufacturing, Cell Therapy
Bristol-Myers Squibb
Associate II Manufacturing, Cell Therapy
Job Description
Learn and execute Cell Therapy Manufacturing operations Perform patient process unit operations and support operations described in standard operating procedures and batch records Executes transactions and process in all electronic systems Prioritizes safety of self and others Reports safety events within 24 hours Escalates any/all issues that may impact safety of self and/or others. Complete documentation required by governing controlled documents and batch records Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements Complete training assignments to ensure the necessary technical skills and knowledge Trains for proficiency in process systems and some supporting business systems Execute daily unit operations schedule, that includes people, product, and material flow across multiple shifts Work within a controlled cleanroom environment and execute aseptic processing procedures (as assigned). 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 Continues to refine and improve manufacturing process technique to improve individual operational times. Ensures training completion prior to production Demonstrate strong practical and theoretical knowledge Collaborate with support groups on recommendations and solving technical and operational problems Train others on SOPs and Work Instructions to successfully complete manufacturing operations. Associate or bachelor's degree in related field is preferred. A minimum high school diploma and/or equivalent combination of education and experience is required. MBO 3 of 4 in science related field and/or equivalent Experience: 1+ years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education Extensive knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing 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 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
Key Responsibilities
- Learn and execute Cell Therapy Manufacturing operations
- Perform patient process unit operations and support operations described in standard operating procedures and batch records
- Executes transactions and process in all electronic systems
- Prioritizes safety of self and others
- Reports safety events within 24 hours
- Escalates any/all issues that may impact safety of self and/or others
- Complete documentation required by governing controlled documents and batch records
- Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements
- Complete training assignments to ensure the necessary technical skills and knowledge
- Trains for proficiency in process systems and some supporting business systems
- Execute daily unit operations schedule, that includes people, product, and material flow across multiple shifts
- Work within a controlled cleanroom environment and execute aseptic processing procedures (as assigned)
- 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
- Continues to refine and improve manufacturing process technique to improve individual operational times
- Ensures training completion prior to production
- Demonstrate strong practical and theoretical knowledge
- Collaborate with support groups on recommendations and solving technical and operational problems
- Train others on SOPs and Work Instructions to successfully complete manufacturing operations
Required Qualifications
- A minimum high school diploma and/or equivalent combination of education and experience
- MBO 3 of 4 in science related field and/or equivalent
- + years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education
Preferred Qualifications
- Associate or bachelor's degree in related field
- Extensive knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
- Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence
- Demonstrated aptitude for engineering principles and manufacturing systems
- 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
Skills Required
- 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
Locations
- Leiden – NL, United States
Salary
Estimated Salary Rangemedium confidence
60,000 - 90,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applicationsintermediate
- Demonstrated good interpersonal skills, is attentive and approachableintermediate
- Maintain a professional and productive relationship with area management and co-workersintermediate
Required Qualifications
- A minimum high school diploma and/or equivalent combination of education and experience (experience)
- MBO 3 of 4 in science related field and/or equivalent (experience)
- + years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education (experience)
Preferred Qualifications
- Associate or bachelor's degree in related field (experience)
- Extensive knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing (experience)
- Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence (experience)
- Demonstrated aptitude for engineering principles and manufacturing systems (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)
Responsibilities
- Learn and execute Cell Therapy Manufacturing operations
- Perform patient process unit operations and support operations described in standard operating procedures and batch records
- Executes transactions and process in all electronic systems
- Prioritizes safety of self and others
- Reports safety events within 24 hours
- Escalates any/all issues that may impact safety of self and/or others
- Complete documentation required by governing controlled documents and batch records
- Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements
- Complete training assignments to ensure the necessary technical skills and knowledge
- Trains for proficiency in process systems and some supporting business systems
- Execute daily unit operations schedule, that includes people, product, and material flow across multiple shifts
- Work within a controlled cleanroom environment and execute aseptic processing procedures (as assigned)
- 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
- Continues to refine and improve manufacturing process technique to improve individual operational times
- Ensures training completion prior to production
- Demonstrate strong practical and theoretical knowledge
- Collaborate with support groups on recommendations and solving technical and operational problems
- Train others on SOPs and Work Instructions to successfully complete manufacturing operations
Tags & Categories
Answer 10 quick questions to check your fit for Associate II Manufacturing, Cell Therapy @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs