Associate III Manufacturing, Cell Therapy
Bristol-Myers Squibb
Associate III Manufacturing, Cell Therapy
Job Description
Execute operations as outlined in Standard Operating Procedures (SOPs) and batch records Executes transactions and process in all electronic systems 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 Train for proficiency in process systems and some supporting business systems Work within a controlled cleanroom environment and perform aseptic processing (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 Able to train new operators Role models and leaders for the culture of compliance Controlled document & Deviation authoring, change impact assessment and action owner Demonstrate a strong practical and theoretical knowledge in their work Can represent department in cross-functional department collaborations May before Team Lead duties as needed / delegated Complete documentation required by governing controlled documents and batch records Solve complex technical problems; takes new perspectives using existing solutions Train others on SOPs, 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: 3+ 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
- Execute operations as outlined in Standard Operating Procedures (SOPs) and batch records
- Execute transactions and processes in all electronic systems
- Perform all tasks in a manner consistent with safety policies, SOPs, quality systems, and GMP requirements
- Complete training assignments to ensure necessary technical skills and knowledge
- Train for proficiency in process systems and some supporting business systems
- Work within a controlled cleanroom environment and perform aseptic processing
- Maintain manufacturing environmental conditions by performing area disinfection regiment as required to meet global Health Authority requirements
- Able to train new operators
- Role model and leader for the culture of compliance
- Controlled document & Deviation authoring, change impact assessment, and action owner
- Demonstrate strong practical and theoretical knowledge in work
- Represent department in cross-functional department collaborations
- May perform Team Lead duties as needed/delegated
- Complete documentation required by governing controlled documents and batch records
- Solve complex technical problems; take new perspectives using existing solutions
- Train others on SOPs, Work Instructions to successfully complete manufacturing operations
Required Qualifications
- Associate or bachelor's degree in a related field preferred
- Minimum high school diploma and/or equivalent combination of education and experience required
- MBO 3 or 4 in a science-related field and/or equivalent
- + years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education
Preferred Qualifications
- Extensive knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
- Peer-level on the floor leadership experience demonstrating 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, attentive and approachable
Skills Required
- Ability to work in a controlled cleanroom environment
- Aseptic processing skills
- Strong practical and theoretical knowledge in work
- Good interpersonal skills, attentive and approachable
- Proficiency in common computer tools such as word processing, spreadsheet, and web-based applications
- Ability to solve complex technical problems and take new perspectives using existing solutions
Additional Requirements
- Maintain a professional and productive relationship with area management and co-workers
Locations
- Leiden – NL, United States
Salary
Estimated Salary Rangemedium confidence
70,000 - 110,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to work in a controlled cleanroom environmentintermediate
- Aseptic processing skillsintermediate
- Strong practical and theoretical knowledge in workintermediate
- Good interpersonal skills, attentive and approachableintermediate
- Proficiency in common computer tools such as word processing, spreadsheet, and web-based applicationsintermediate
- Ability to solve complex technical problems and take new perspectives using existing solutionsintermediate
Required Qualifications
- Associate or bachelor's degree in a related field preferred (experience)
- Minimum high school diploma and/or equivalent combination of education and experience required (experience)
- MBO 3 or 4 in a science-related field and/or equivalent (experience)
- + years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education (experience)
Preferred Qualifications
- Extensive knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing (experience)
- Peer-level on the floor leadership experience demonstrating 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, attentive and approachable (experience)
Responsibilities
- Execute operations as outlined in Standard Operating Procedures (SOPs) and batch records
- Execute transactions and processes in all electronic systems
- Perform all tasks in a manner consistent with safety policies, SOPs, quality systems, and GMP requirements
- Complete training assignments to ensure necessary technical skills and knowledge
- Train for proficiency in process systems and some supporting business systems
- Work within a controlled cleanroom environment and perform aseptic processing
- Maintain manufacturing environmental conditions by performing area disinfection regiment as required to meet global Health Authority requirements
- Able to train new operators
- Role model and leader for the culture of compliance
- Controlled document & Deviation authoring, change impact assessment, and action owner
- Demonstrate strong practical and theoretical knowledge in work
- Represent department in cross-functional department collaborations
- May perform Team Lead duties as needed/delegated
- Complete documentation required by governing controlled documents and batch records
- Solve complex technical problems; take new perspectives using existing solutions
- Train others on SOPs, Work Instructions to successfully complete manufacturing operations
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Answer 10 quick questions to check your fit for Associate III Manufacturing, Cell Therapy @ Bristol-Myers Squibb.
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Associate III Manufacturing, Cell Therapy
Bristol-Myers Squibb
Associate III Manufacturing, Cell Therapy
Job Description
Execute operations as outlined in Standard Operating Procedures (SOPs) and batch records Executes transactions and process in all electronic systems 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 Train for proficiency in process systems and some supporting business systems Work within a controlled cleanroom environment and perform aseptic processing (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 Able to train new operators Role models and leaders for the culture of compliance Controlled document & Deviation authoring, change impact assessment and action owner Demonstrate a strong practical and theoretical knowledge in their work Can represent department in cross-functional department collaborations May before Team Lead duties as needed / delegated Complete documentation required by governing controlled documents and batch records Solve complex technical problems; takes new perspectives using existing solutions Train others on SOPs, 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: 3+ 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
- Execute operations as outlined in Standard Operating Procedures (SOPs) and batch records
- Execute transactions and processes in all electronic systems
- Perform all tasks in a manner consistent with safety policies, SOPs, quality systems, and GMP requirements
- Complete training assignments to ensure necessary technical skills and knowledge
- Train for proficiency in process systems and some supporting business systems
- Work within a controlled cleanroom environment and perform aseptic processing
- Maintain manufacturing environmental conditions by performing area disinfection regiment as required to meet global Health Authority requirements
- Able to train new operators
- Role model and leader for the culture of compliance
- Controlled document & Deviation authoring, change impact assessment, and action owner
- Demonstrate strong practical and theoretical knowledge in work
- Represent department in cross-functional department collaborations
- May perform Team Lead duties as needed/delegated
- Complete documentation required by governing controlled documents and batch records
- Solve complex technical problems; take new perspectives using existing solutions
- Train others on SOPs, Work Instructions to successfully complete manufacturing operations
Required Qualifications
- Associate or bachelor's degree in a related field preferred
- Minimum high school diploma and/or equivalent combination of education and experience required
- MBO 3 or 4 in a science-related field and/or equivalent
- + years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education
Preferred Qualifications
- Extensive knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
- Peer-level on the floor leadership experience demonstrating 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, attentive and approachable
Skills Required
- Ability to work in a controlled cleanroom environment
- Aseptic processing skills
- Strong practical and theoretical knowledge in work
- Good interpersonal skills, attentive and approachable
- Proficiency in common computer tools such as word processing, spreadsheet, and web-based applications
- Ability to solve complex technical problems and take new perspectives using existing solutions
Additional Requirements
- Maintain a professional and productive relationship with area management and co-workers
Locations
- Leiden – NL, United States
Salary
Estimated Salary Rangemedium confidence
70,000 - 110,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to work in a controlled cleanroom environmentintermediate
- Aseptic processing skillsintermediate
- Strong practical and theoretical knowledge in workintermediate
- Good interpersonal skills, attentive and approachableintermediate
- Proficiency in common computer tools such as word processing, spreadsheet, and web-based applicationsintermediate
- Ability to solve complex technical problems and take new perspectives using existing solutionsintermediate
Required Qualifications
- Associate or bachelor's degree in a related field preferred (experience)
- Minimum high school diploma and/or equivalent combination of education and experience required (experience)
- MBO 3 or 4 in a science-related field and/or equivalent (experience)
- + years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education (experience)
Preferred Qualifications
- Extensive knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing (experience)
- Peer-level on the floor leadership experience demonstrating 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, attentive and approachable (experience)
Responsibilities
- Execute operations as outlined in Standard Operating Procedures (SOPs) and batch records
- Execute transactions and processes in all electronic systems
- Perform all tasks in a manner consistent with safety policies, SOPs, quality systems, and GMP requirements
- Complete training assignments to ensure necessary technical skills and knowledge
- Train for proficiency in process systems and some supporting business systems
- Work within a controlled cleanroom environment and perform aseptic processing
- Maintain manufacturing environmental conditions by performing area disinfection regiment as required to meet global Health Authority requirements
- Able to train new operators
- Role model and leader for the culture of compliance
- Controlled document & Deviation authoring, change impact assessment, and action owner
- Demonstrate strong practical and theoretical knowledge in work
- Represent department in cross-functional department collaborations
- May perform Team Lead duties as needed/delegated
- Complete documentation required by governing controlled documents and batch records
- Solve complex technical problems; take new perspectives using existing solutions
- Train others on SOPs, Work Instructions to successfully complete manufacturing operations
Tags & Categories
Answer 10 quick questions to check your fit for Associate III Manufacturing, Cell Therapy @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs