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ISO 20387

Laboratory Accreditation requirements. The Manager reports directly to the Chief Executive Officer (CEO) and Chief Operating Officer (COO) and provides hands-on oversight of daily technical, quality, service-delivery, and staffing operations. Supervisory Responsibilities Manages the day-to-day activities of the US Biolab Laboratory Services Department, including staff supporting biospecimen processing, IHC/Multiplex IHC testing, molecular services (ISH/FISH), and client service delivery, reporting directly to the CEO and COO. Essential Duties/Major Accountabilities Service Delivery and Operations

Owns day-to-day delivery of laboratory service offerings, ensuring client orders are completed on time, to specification, and to quality standards
Plans staffing requirements, hires to meet service demand, and schedules staff to ensure efficient turnaround and workflow
Monitors turnaround time (TAT) and service-level performance across service lines and drives corrective action when targets are missed
Develops systems for alternative uses of staff to flex with client volume and service demand
Supports development of technical/clinical talent across service lines
Utilizes company resources to implement policies/procedures
Applies Human Resource standards fairly and consistently throughout the department
Facilitates a multi-disciplinary and collaborative approach to interdepartmental problem-solving and service delivery
Fosters an environment of high morale and motivated team members
Oversees protocol development and process improvement to enhance service quality and delivery speed
Manages day-to-day laboratory infrastructure and workflow supporting the company's laboratory service lines
Oversees immunohistochemistry (IHC) and Multiplex IHC testing services, including staining protocols, assay optimization, and technical troubleshooting
Oversees molecular services, including in situ hybridization (ISH) and fluorescence in situ hybridization (FISH) testing, including protocol execution, assay optimization, and technical troubleshooting
Oversees biospecimen processing services for human whole blood, leukopaks and derivatives (serum, plasma, DNA, RNA, immune cell subtypes), FFPE blocks, urine, and other specimen types submitted as part of client service requests
Maintains best-in-class sample logistics as part of the service workflow, including intake, tracking, reconciliation, and timely turnaround to clients
Collaborates with IT and QA to maintain an effective sample traceability process through the LIMS, supporting accurate and timely service delivery
Evaluates standard and emerging technologies to improve service turnaround, quality, and cost-effectiveness
Supports vendor management with external laboratory service providers and may coordinate directly with project managers on client deliverables
Troubleshoots service issues proactively with laboratory staff and relevant stakeholders to ensure timely resolution and minimal client impact Client Service and Growth
Stays current on activities in the laboratory services field and recommends service improvements as needed
Supports space, equipment, and staffing planning in coordination with the CEO/COO to meet growing service demand
Supports the growth, expansion, and implementation of new laboratory service lines and/or site development
Assists in identifying and coordinating with external laboratory partners to extend service offerings
Serves as a primary laboratory point of contact for client service matters, including study design consultation, client troubleshooting, and participation in client calls as needed
Contributes technical and quality data for customer-facing service materials in collaboration with Product and Marketing teams
Assists with development of client-facing FAQs and internal training materials for new services, procedures, and policies
Identifies and recommends service-related business opportunities to leadership Quality
Collaborates with the Quality department to maintain a quality management system enabling consistent evaluation and improvement of services and products
Maintains ongoing quality data collection systems to monitor service levels
Works with laboratory staff and the QA team on a comprehensive quality and training program, including SOPs, CoAs, training records and oversight, and quality testing programs in accordance with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), CAP Biorepository Accreditation standards, and

ISO 20387

laboratory accreditation requirements

Incorporates results of quality audits into the improvement and enhancement of services
Communicates results of laboratory quality processes to relevant stakeholders to improve lab and organizational performance
Maintains current knowledge and utilizes appropriate resources to provide regulatory, consultative, educational, technical, or informational support as needed
Documents all significant quality activities and takes corrective action as necessary
Ensures the lab environment is clean, safe, and free from hazards for staff and guests
Monitors relevant literature for new methods, functions, and products, including advances in IHC, Multiplex IHC, ISH, and FISH techniques Financial Management
Supports the operating budget and adheres to budget throughout the year
Assists with variance analyses; identifies and explains trends
Helps monitor and control costs in relation to volume and pre-established targets
Reconciles statistics and adheres to revenue management standards
Maintains productivity standards; manages staffing levels in relation to volume, service, and financial goals
Supports negotiation of pricing/terms for supplies and maintenance agreements
Assists with equipment purchase proposals, selection, and documentation for equipment acquisition
Supports facility changes and planning Miscellaneous
Maintains a clean personal workspace
Maintains confidentiality of all US Biolab business
Takes on other duties as assigned or required by management when needs arise Accountability Standards for All Department Staff
Dependability, reliability, flexibility, adaptability, integrity, and communication
Ability to function successfully in a team setting and assist co-workers with departmental workflow as directed by the CEO or Chief Operating Officer Minimum Required Knowledge, Skills and Abilities
PhD or MSc degree or equivalent in one of the biological sciences
Hands-on experience with immunohistochemistry (IHC), ISH, Multiplex IHC required; experience with FISH strongly preferred
4 or more years of full-time general laboratory training and experience, including experience in biorepository operations, IHC/Multiplex IHC testing, and molecular services such as

ISH/FISH

Working knowledge of laboratory regulations and experience supporting laboratory service operations in accordance with CAP Biorepository Accreditation standards, ISO 20387 (General requirements for biobanking), and Good Laboratory Practice (GLP)
Working knowledge of biospecimen handling and cell-based services/assays as part of a client service offering
Solid technical and operational skills, with the ability to manage day-to-day laboratory service delivery effectively
Excellent communication and organizational skills; strong project management skills and ability to collaborate with internal and external stakeholders
Demonstrated leadership and team management experience
Demonstrated ability to effectively communicate across multidisciplinary departments
Problem-solving and decision-making skills; ability to appropriately confront and resolve issues
Ability to build teams and motivate individuals and groups
Ability to plan, organize, and direct the activities of others
Ability to communicate well and support change across the organization
Demonstrated sound, logical decision-making abilities
Organized and able to operate effectively with moderate day-to-day oversight, while following senior leadership's guidance and staying closely connected to key stakeholders Additional Preferred Qualifications
Proficient in Microsoft Office/365, Teams, SharePoint, Salesforce, and other relevant software
Prior experience working toward or maintaining

ISO 20387

laboratory accreditation

Excellent personal relations skills; able to explain procedures in a step-by-step manner Physical Requirements
Must be able to remain in a stationary position for prolonged periods
Must be able to lift and move items up to 10 pounds
Must be able to tolerate frequent exposure to a wide variety of chemicals common to the research industry.

Must be able to wear appropriate personal protective equipment if/when handling samples or materials Hours/Schedule This position is for on-site only.

Pay:

From $98,000.00 per year

Benefits:

401(k) Paid time off Application Question(s): Have you completed the following level of education: Doctor of Philosophy? Are you comfortable working in an onsite setting? How many years of work experience do you have with Histology? How many years of lab operation/management experience do you have? How many years of work experience do you have with Multiplex immunohistochemistry (mIHC)? How many years of work experience do you have with immunohistochemistry (IHC) and ISH?

Work Location:

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Find & Apply For Clinical Laboratory Manager Jobs in Germantown, Maryland

Laboratory Manager Histology and Molecular