Manager, Laboratory Operations
Job descriptionJOB OVERVIEWResponsible for managing a team of 10-15 laboratory staff conducting a variety of cell-based assays supporting vaccine clinical trials.
Assists with administration of laboratory testing in accordance with applicable regulations governing clinical laboratories.
Frequently interacting with clients, conducting data analysis, writing reports, and troubleshooting any complications with assays.
RESPONSIBILITIES Manage a team of 15
performing cell-based assays for vaccine clinical trials Perform and document all specimen test procedures with accuracy, consistency, and timeliness in accordance with current standard operating procedures (SOPs) and regulatory guidelines.
Complete and prepare documentation in compliance with regulatory and corporate guidelines.
Exercise good judgment in assessing whether test procedure is proceeding according to expectations and that results are within acceptable tolerances.
Perform and document hands on training for other Laboratory Associates in areas of proven competency as assigned.
Identify abnormal progress of test procedure, potential QC failures, or otherwise unusual results and escalate to upper Management immediately.
Act as a backup in any area of daily laboratory operations, as needed, and meet expectations of the laboratory associate job responsibilities in that area.
Oversee the technology transfer of methods and SOPs from other groups within Q2 Solutions such as Research and Development departments.
This includes working with those departments to fill gaps that are identified to ensure the technology will be sustainable and scalable in laboratory operations.
Demonstrate advanced domain knowledge to provide input on technical inquiries and provide leadership in troubleshooting projects.
Including application of root cause analysis and advanced problem-solving techniques.
Produce technical documentation for laboratory assays and associated pipelines across all service areas in the business (i.
e.
, Laboratory Ops, Quality Systems, Information Technology, and Finance).
Identify and lead continuous process improvement initiatives for laboratory operations, including but not limited to the following
Responsibilities:
Review of laboratory metrics to identify initiatives as well as establish additional metrics such as cost savings that are associated with process improvement initiatives.
Work with stakeholders on process improvement initiatives to present projects and ensure that goals are met.
Independently identify and evaluate vendor platforms to that may help meet goals of the initiatives.
Documentation of all project aspects including formal validations of laboratory methods.
Present findings to a wide variety of audiences internal and external to Q2 Solutions.
MINIMUM EDUCATION REQUIRED AND EXPERIENCEBachelor's Degree in a technical field preferred with minimum of 4 years of prior relevant experience or equivalent combination of education and experience.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES Demonstrated subject matter expertise in cell culture.
Knowledge of neutralization assays preferred.
Former manager experience required.
Demonstrated attention to detail, flexibility, and initiative.
Demonstrated teamwork/interpersonal skills, project management skills.
Oral/written communication skills and customer-client orientation.
Decision making ability, results orientation, problem-solving ability.
Ability to maintain accurate records.
Ability to maintain clean and efficient laboratory operations.
Ability to perform fully GLP/GCP compliant sample and reference compound custody.
Ability to provide effective client communication.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Ability to trouble-shoot and perform minor repairs to daily use equipment.
Basic biological lab knowledge and how it relates to a safety in the workplace.
Q Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.
https:
//www.
q2labsolutions.
com/careers />We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.
https:
//jobs.
iqvia.
com/q2-solutions-eoe />As the COVID-19 virus continues to evolve, Q Solutions' ability to operate and provide certain services to customers and partners necessitates Q Solutions and its employees meet specific requirements regarding vaccination status.
https:
//jobs.
iqvia.
com/q2-solutions-covid-19-vaccine-status Recommended Skills Administration Attention To Detail Biology Business Process Improvement Cell Cultures Clinical Trials Estimated Salary: $20 to $28 per hour based on qualifications.
Assists with administration of laboratory testing in accordance with applicable regulations governing clinical laboratories.
Frequently interacting with clients, conducting data analysis, writing reports, and troubleshooting any complications with assays.
RESPONSIBILITIES Manage a team of 15
performing cell-based assays for vaccine clinical trials Perform and document all specimen test procedures with accuracy, consistency, and timeliness in accordance with current standard operating procedures (SOPs) and regulatory guidelines.
Complete and prepare documentation in compliance with regulatory and corporate guidelines.
Exercise good judgment in assessing whether test procedure is proceeding according to expectations and that results are within acceptable tolerances.
Perform and document hands on training for other Laboratory Associates in areas of proven competency as assigned.
Identify abnormal progress of test procedure, potential QC failures, or otherwise unusual results and escalate to upper Management immediately.
Act as a backup in any area of daily laboratory operations, as needed, and meet expectations of the laboratory associate job responsibilities in that area.
Oversee the technology transfer of methods and SOPs from other groups within Q2 Solutions such as Research and Development departments.
This includes working with those departments to fill gaps that are identified to ensure the technology will be sustainable and scalable in laboratory operations.
Demonstrate advanced domain knowledge to provide input on technical inquiries and provide leadership in troubleshooting projects.
Including application of root cause analysis and advanced problem-solving techniques.
Produce technical documentation for laboratory assays and associated pipelines across all service areas in the business (i.
e.
, Laboratory Ops, Quality Systems, Information Technology, and Finance).
Identify and lead continuous process improvement initiatives for laboratory operations, including but not limited to the following
Responsibilities:
Review of laboratory metrics to identify initiatives as well as establish additional metrics such as cost savings that are associated with process improvement initiatives.
Work with stakeholders on process improvement initiatives to present projects and ensure that goals are met.
Independently identify and evaluate vendor platforms to that may help meet goals of the initiatives.
Documentation of all project aspects including formal validations of laboratory methods.
Present findings to a wide variety of audiences internal and external to Q2 Solutions.
MINIMUM EDUCATION REQUIRED AND EXPERIENCEBachelor's Degree in a technical field preferred with minimum of 4 years of prior relevant experience or equivalent combination of education and experience.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES Demonstrated subject matter expertise in cell culture.
Knowledge of neutralization assays preferred.
Former manager experience required.
Demonstrated attention to detail, flexibility, and initiative.
Demonstrated teamwork/interpersonal skills, project management skills.
Oral/written communication skills and customer-client orientation.
Decision making ability, results orientation, problem-solving ability.
Ability to maintain accurate records.
Ability to maintain clean and efficient laboratory operations.
Ability to perform fully GLP/GCP compliant sample and reference compound custody.
Ability to provide effective client communication.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Ability to trouble-shoot and perform minor repairs to daily use equipment.
Basic biological lab knowledge and how it relates to a safety in the workplace.
Q Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.
https:
//www.
q2labsolutions.
com/careers />We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.
https:
//jobs.
iqvia.
com/q2-solutions-eoe />As the COVID-19 virus continues to evolve, Q Solutions' ability to operate and provide certain services to customers and partners necessitates Q Solutions and its employees meet specific requirements regarding vaccination status.
https:
//jobs.
iqvia.
com/q2-solutions-covid-19-vaccine-status Recommended Skills Administration Attention To Detail Biology Business Process Improvement Cell Cultures Clinical Trials Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
