The Laboratory Manager is responsible for overseeing the daily operations of a high-complexity clinical and/or translational laboratory within a CAP/CLIA-regulated environment. This role ensures scientific excellence regulatory compliance and operational efficiency across Immunohistochemistry (IHC) and Fluorescence In Situ Hybridization (FISH) testing.
In a Contract Research Organization (CRO) setting the Laboratory Manager partners closely with cross-functional teams to support client-driven projects clinical trials and biomarker development efforts.
Essential functions of the job include but are not limited to:
Oversee IHC and FISH analyses support assay development and cross-train laboratory personnel on regulated IHC and FISH SOPs
Manage testing personnel and ensure adherence to CAP/CLIA and GxP guidelines relevant to each assay/study
Develop and manage staff schedules including rotation and holiday coverage; serve as backup for laboratory testing as needed
Ensure laboratory procedures are performed in accordance with SOPs by appropriately trained personnel; address deviations promptly and report issues to management and QA
Ensure accurate sample tracking and testing documentation within LIMS
Monitor and report KPIs including turnaround time (TAT) quality event investigations and closures staff capacity and special project progress
Maintain proficiency in laboratory operations by completing training on all relevant SOPs
Oversee laboratory equipment and workspaces to ensure they are clean well-maintained and fully operational
Recommend equipment replacement or maintenance based on performance and notify management/QA of any issues
Monitor inventory of laboratory supplies reagents and consumables; order and replenish as needed
Identify opportunities to improve efficiency and reduce laboratory supply costs
Maintain competency across applicable assays and serve as backup testing personnel when necessary
Drive efficient use of time resources and equipment
Evaluate and improve laboratory procedures; provide recommendations to management
Perform other duties as assigned
Qualifications:
Minimum Required:
Bachelors degree in Biology Chemistry or a related scientific field
8 years of industry experience in a clinical diagnostic or CRO laboratory including hands-on IHC assay experience
2 years of leadership experience in a CAP- or CLIA-regulated laboratory
ASCP certification (HT or equivalent)
Other Required:
Strong organizational and time management skills
Ability to work independently and make decisions with minimal supervision
Experience operating analytical instruments commonly used in laboratory settings
Proficiency in Microsoft Office (Word Excel PowerPoint)
Strong communication and interpersonal skills with the ability to directly supervise staff
Demonstrated sound judgment and discretion
Ability to read write and speak English fluently
Willingness to work extended hours including evenings weekends and holidays and occasional travel as required to support business and scientific objectives
Preferred:
Specialized knowledge in biochemistry immunology molecular biology or cell biology
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets experience and training licensure and certifications and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus health insurance retirement savings benefits life insurance and disability benefits parental leave and paid time off for sick leave and vacation among other benefits.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race color age religion sex sexual orientation gender identity national origin disability veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying you may contact Precision Medicine Group at .
Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal financial or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment banking details or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam we encourage you to report the incident to your local law enforcement authorities consumer protection agency or relevant cybercrime reporting organization in your country. Please also notify us at so we can investigate and take appropriate action.
Required Experience:
Manager
Position Summary:The Laboratory Manager is responsible for overseeing the daily operations of a high-complexity clinical and/or translational laboratory within a CAP/CLIA-regulated environment. This role ensures scientific excellence regulatory compliance and operational efficiency across Immunohist...
Position Summary:
The Laboratory Manager is responsible for overseeing the daily operations of a high-complexity clinical and/or translational laboratory within a CAP/CLIA-regulated environment. This role ensures scientific excellence regulatory compliance and operational efficiency across Immunohistochemistry (IHC) and Fluorescence In Situ Hybridization (FISH) testing.
In a Contract Research Organization (CRO) setting the Laboratory Manager partners closely with cross-functional teams to support client-driven projects clinical trials and biomarker development efforts.
Essential functions of the job include but are not limited to:
Oversee IHC and FISH analyses support assay development and cross-train laboratory personnel on regulated IHC and FISH SOPs
Manage testing personnel and ensure adherence to CAP/CLIA and GxP guidelines relevant to each assay/study
Develop and manage staff schedules including rotation and holiday coverage; serve as backup for laboratory testing as needed
Ensure laboratory procedures are performed in accordance with SOPs by appropriately trained personnel; address deviations promptly and report issues to management and QA
Ensure accurate sample tracking and testing documentation within LIMS
Monitor and report KPIs including turnaround time (TAT) quality event investigations and closures staff capacity and special project progress
Maintain proficiency in laboratory operations by completing training on all relevant SOPs
Oversee laboratory equipment and workspaces to ensure they are clean well-maintained and fully operational
Recommend equipment replacement or maintenance based on performance and notify management/QA of any issues
Monitor inventory of laboratory supplies reagents and consumables; order and replenish as needed
Identify opportunities to improve efficiency and reduce laboratory supply costs
Maintain competency across applicable assays and serve as backup testing personnel when necessary
Drive efficient use of time resources and equipment
Evaluate and improve laboratory procedures; provide recommendations to management
Perform other duties as assigned
Qualifications:
Minimum Required:
Bachelors degree in Biology Chemistry or a related scientific field
8 years of industry experience in a clinical diagnostic or CRO laboratory including hands-on IHC assay experience
2 years of leadership experience in a CAP- or CLIA-regulated laboratory
ASCP certification (HT or equivalent)
Other Required:
Strong organizational and time management skills
Ability to work independently and make decisions with minimal supervision
Experience operating analytical instruments commonly used in laboratory settings
Proficiency in Microsoft Office (Word Excel PowerPoint)
Strong communication and interpersonal skills with the ability to directly supervise staff
Demonstrated sound judgment and discretion
Ability to read write and speak English fluently
Willingness to work extended hours including evenings weekends and holidays and occasional travel as required to support business and scientific objectives
Preferred:
Specialized knowledge in biochemistry immunology molecular biology or cell biology
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets experience and training licensure and certifications and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus health insurance retirement savings benefits life insurance and disability benefits parental leave and paid time off for sick leave and vacation among other benefits.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race color age religion sex sexual orientation gender identity national origin disability veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying you may contact Precision Medicine Group at .
Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal financial or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment banking details or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam we encourage you to report the incident to your local law enforcement authorities consumer protection agency or relevant cybercrime reporting organization in your country. Please also notify us at so we can investigate and take appropriate action.
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