Senior Manager, Quality Control Microbiology (4750)
Job Summary Lead all aspects of microbial Quality Control in support of bio therapeutic product manufacturing.
Manage environmental and utility programs and microbiological testing.
Play a key role in supporting the manufacturing plant's contamination control strategy and serve as the technical lead for evaluating, validating, and implementing microbiology methods.
Manage and schedule analysts to perform job functions.
Oversee EM and Micro laboratory data, final report, and lab operation.
Responsible for the quality and on-time delivery of test results, validation data, and all other QC deliverables to internal and external clients.
Demonstrate strong oral and written communication skills and actively contribute to training, report generation, and documentation.
Demonstrate strong supervisory skills and contributes to the achievement of company and departmental goals and objectives.
Job Functions In charge of QC EM and Micro team which covers the environmental monitoring testing program and microbiological testing for raw material, in-process and release samples.
Manage environmental monitoring and site contamination control programs, including EM risk assessment, testing, trending, interpretation of EM data, and oversight of the EM excursion business process.
Lead investigations and/or change control strategies for processes that impact environmental control.
Work closely with stakeholders in manufacturing, engineering, and validation to drive alignment to site contamination control goals and standards.
Responsible for establishing the microbiology testing function.
Serve as a key member of the Quality organization and subject matter expert on microbiological assays and new technology.
Provides key input and recommendation of data review or investigation process.
Serves as lead for client discussions regarding project quality or investigations/nonconformances as they relate to studies.
Conduct and direct assays and lab procedures according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
Provide training on areas of technical expertise and compliance issues relevant to the Micro Biology Lab.
Author, review, and approve SOPs, validation protocols, investigations, specifications, and related documents.
Closely work with staff members to initiate Microbiology deviations, CAPA, OOS, and OOL investigations.
Provides operational, technical, and administrative leadership to the Microbiology Department through supervision and planning.
Supervise, plan, and review operations for assigned staff members, including responsibilities for training, managing, and evaluating, as well as coordinating, scheduling, and assigning work.
Plan and budget for Lab personnel, supplies, and equipment resources.
Closely work with internal and external stakeholders to assure that the appropriate information is effectively communicated and documented.
Job RequirementTechnical Skills / Knowledge In-depth knowledge of microbial contamination control, microbiological methods and demonstrated capability in using that knowledge to provide Quality leadership to all aspect of microbiology.
Subject matter expertise and hands-on proficiency with all aspects of pharmaceutical microbial control.
Hands-on experience with microbiological methods such as Bacteriostasis and Fungistasis, endotoxin testing, bioburden and sterility testing.
Experience and extensive understanding of environmental control regulations and guidelines with in-depth understanding of cGMPs.
Experience validating and executing microbiological testing methods, identification methods, and evaluating new technology.
Experience with application of root cause analysis tools for the purpose of investigation execution.
Experience with Quality Systems (e.
g.
Document management system, Quality Management System, Learning management system, Change Control, Deviations, and CAPA programs).
Working knowledge of electronic quality systems/software applicationsIndependence/Accountability:
Must work in a self-motivated, highly flexible, well organized and detailed-oriented style.
in this leadership position require some evening conference call time.
Ability to rapidly pivot between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives.
Problem Solving:
Proven experience in risk mitigation planning and ability to solve complex QC technical and operation problems.
Candidate should be able to make appropriate judgment and decisions based on available informtation and data to ensure the safety and success of the manufacturing support and product testing.
Leadership Activities:
Proven track record of leading QC Microbiology function in bio manufacturing industry.
Candidate should possess strong and effective people management, problem solving and interpersonal skills.
Work closely with team members across all WuXi Biologics units and management teams to ensure coordination of all efforts and real-time communication with all stakeholders.
Demonstrate leadership skills in building team and developing the team.
Communication Skills:
Proficiency in English is required.
Excellent communications skills (verbal, written, and presentation skills).
Must be able to collaborate with clients, internal stakeholders, and support functions to achieve alignment and work effectively.
Education and
Experience:
Minimum Bachelor of Science degree and/or advanced Graduate degree in Chemistry, Microbiology, Biochemistry or equivalent field.
10
years of relevant experience or equivalent for Bachelors', 8
years for Master's in the Quality Control or related field or equivalent experience.
5
years' supervisory responsibilities in Pharmaceutical industry with emphasis in aseptic processing, QC microbiology, environmental monitoring, water systems, cGMP, and validation.
Physical Requirements:
Must be able to work in Lab setting with Biohazards /various Chemicals Must be able to wear appropriate PPE.
Must be able to work in environment with variable noise levels.
Ability to stand or sit for long periods of time.
Ability to perform light physical work, lifting up to 20 pounds as needed.
Ability to crouch, bend, twist, and reach.
Clarity of vision at all ranges, depth perception, and ability to identify and distinguish colors.
Must be able to perform activities with repetitive motions.
The job description does not intend to list all the duties and responsibilities assigned to this position.
Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.
Recommended Skills Administration Asepsis Biochemistry Biology Business Processes Document Management Systems Estimated Salary: $20 to $28 per hour based on qualifications.
Manage environmental and utility programs and microbiological testing.
Play a key role in supporting the manufacturing plant's contamination control strategy and serve as the technical lead for evaluating, validating, and implementing microbiology methods.
Manage and schedule analysts to perform job functions.
Oversee EM and Micro laboratory data, final report, and lab operation.
Responsible for the quality and on-time delivery of test results, validation data, and all other QC deliverables to internal and external clients.
Demonstrate strong oral and written communication skills and actively contribute to training, report generation, and documentation.
Demonstrate strong supervisory skills and contributes to the achievement of company and departmental goals and objectives.
Job Functions In charge of QC EM and Micro team which covers the environmental monitoring testing program and microbiological testing for raw material, in-process and release samples.
Manage environmental monitoring and site contamination control programs, including EM risk assessment, testing, trending, interpretation of EM data, and oversight of the EM excursion business process.
Lead investigations and/or change control strategies for processes that impact environmental control.
Work closely with stakeholders in manufacturing, engineering, and validation to drive alignment to site contamination control goals and standards.
Responsible for establishing the microbiology testing function.
Serve as a key member of the Quality organization and subject matter expert on microbiological assays and new technology.
Provides key input and recommendation of data review or investigation process.
Serves as lead for client discussions regarding project quality or investigations/nonconformances as they relate to studies.
Conduct and direct assays and lab procedures according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
Provide training on areas of technical expertise and compliance issues relevant to the Micro Biology Lab.
Author, review, and approve SOPs, validation protocols, investigations, specifications, and related documents.
Closely work with staff members to initiate Microbiology deviations, CAPA, OOS, and OOL investigations.
Provides operational, technical, and administrative leadership to the Microbiology Department through supervision and planning.
Supervise, plan, and review operations for assigned staff members, including responsibilities for training, managing, and evaluating, as well as coordinating, scheduling, and assigning work.
Plan and budget for Lab personnel, supplies, and equipment resources.
Closely work with internal and external stakeholders to assure that the appropriate information is effectively communicated and documented.
Job RequirementTechnical Skills / Knowledge In-depth knowledge of microbial contamination control, microbiological methods and demonstrated capability in using that knowledge to provide Quality leadership to all aspect of microbiology.
Subject matter expertise and hands-on proficiency with all aspects of pharmaceutical microbial control.
Hands-on experience with microbiological methods such as Bacteriostasis and Fungistasis, endotoxin testing, bioburden and sterility testing.
Experience and extensive understanding of environmental control regulations and guidelines with in-depth understanding of cGMPs.
Experience validating and executing microbiological testing methods, identification methods, and evaluating new technology.
Experience with application of root cause analysis tools for the purpose of investigation execution.
Experience with Quality Systems (e.
g.
Document management system, Quality Management System, Learning management system, Change Control, Deviations, and CAPA programs).
Working knowledge of electronic quality systems/software applicationsIndependence/Accountability:
Must work in a self-motivated, highly flexible, well organized and detailed-oriented style.
in this leadership position require some evening conference call time.
Ability to rapidly pivot between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives.
Problem Solving:
Proven experience in risk mitigation planning and ability to solve complex QC technical and operation problems.
Candidate should be able to make appropriate judgment and decisions based on available informtation and data to ensure the safety and success of the manufacturing support and product testing.
Leadership Activities:
Proven track record of leading QC Microbiology function in bio manufacturing industry.
Candidate should possess strong and effective people management, problem solving and interpersonal skills.
Work closely with team members across all WuXi Biologics units and management teams to ensure coordination of all efforts and real-time communication with all stakeholders.
Demonstrate leadership skills in building team and developing the team.
Communication Skills:
Proficiency in English is required.
Excellent communications skills (verbal, written, and presentation skills).
Must be able to collaborate with clients, internal stakeholders, and support functions to achieve alignment and work effectively.
Education and
Experience:
Minimum Bachelor of Science degree and/or advanced Graduate degree in Chemistry, Microbiology, Biochemistry or equivalent field.
10
years of relevant experience or equivalent for Bachelors', 8
years for Master's in the Quality Control or related field or equivalent experience.
5
years' supervisory responsibilities in Pharmaceutical industry with emphasis in aseptic processing, QC microbiology, environmental monitoring, water systems, cGMP, and validation.
Physical Requirements:
Must be able to work in Lab setting with Biohazards /various Chemicals Must be able to wear appropriate PPE.
Must be able to work in environment with variable noise levels.
Ability to stand or sit for long periods of time.
Ability to perform light physical work, lifting up to 20 pounds as needed.
Ability to crouch, bend, twist, and reach.
Clarity of vision at all ranges, depth perception, and ability to identify and distinguish colors.
Must be able to perform activities with repetitive motions.
The job description does not intend to list all the duties and responsibilities assigned to this position.
Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.
Recommended Skills Administration Asepsis Biochemistry Biology Business Processes Document Management Systems Estimated Salary: $20 to $28 per hour based on qualifications.
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