Sample Extraction Manager - Medical Device

GENERAL DESCRIPTION:

The Sample Extraction Manager is responsible for managing, coordinating, and overseeing all test article extraction activities performed in support of toxicology and related laboratory studies. This position supervises Sample Preparation Scientists, establishes departmental priorities and schedules, and ensures that preparations are completed accurately, efficiently, and in accordance with study protocols, PSL standard operating procedures, Good Laboratory Practices, and applicable safety requirements.

The Sample Extraction Manager serves as a primary technical and operational contact for clients, Study Directors, and laboratory personnel regarding extraction and preparation requirements. This individual is responsible for evaluating test articles and client instructions, resolving technical questions, and developing clear, detailed, study-specific instructions that laboratory personnel can follow when performing individual sample preparations.

Supervisory Responsibilities:

The Sample Extraction Manager directly supervises Sample Preparation Scientists and other assigned extraction or preparation personnel. Supervisory responsibilities include:

• Assigning and prioritizing daily and long-term departmental work.
• Coordinating staffing and resources to meet study schedules.
• Providing technical direction and day-to-day support.
• Training personnel on protocols, procedures, equipment, calculations, documentation, and safety requirements.
• Evaluating employee competency and work quality.
• Conducting performance evaluations and providing timely coaching and feedback.
• Addressing performance, attendance, conduct, or training concerns in coordination with laboratory management and Human Resources.
• Promoting teamwork, accountability, effective communication, and continuous improvement within the department.

Specific Responsibilities:

• Manage and oversee the evaluation, preparation, extraction, storage, and disposition of test articles submitted for testing.
• Review study protocols, client instructions, test article information, and other supporting documentation to determine preparation and extraction requirements.
• Communicate directly with clients to obtain clarification regarding test article characteristics, preparation requirements, extraction conditions, sample configuration, storage conditions, or other information necessary to perform the work.
• Serve as the primary departmental contact for Study Directors, scientific staff, and laboratory management regarding sample preparation feasibility, requirements, scheduling, status, and technical concerns.
• Translate client requirements, study protocols, and PSL procedures into clear, detailed, and executable preparation instructions for each individual preparation.
• Develop and issue preparation worksheets, extraction instructions, or other controlled documentation.
• Determine or verify test article surface area and calculate required extraction ratios, preparation concentrations, dilution factors, and final volumes.
• Review and approve calculations and preparation instructions before work is initiated.
• Evaluate the technical feasibility of requested preparations and promptly communicate any concerns, inconsistencies, missing information, or deviations from established procedures.
• Coordinate sample preparation and extraction schedules with Study Directors, laboratory departments, and other scientific personnel to support study initiation and dosing timelines.
• Assign preparations to qualified personnel based on study priority, technical complexity, staff competency, equipment availability, and departmental workload.
• Monitor departmental workload and preparation status to ensure that deadlines and study requirements are met.
• Provide hands-on technical support and perform sample preparations or extractions when required.
• Ensure that samples, extracts, and dosing solutions are prepared according to study protocols, approved instructions, and PSL standard operating procedures using appropriate laboratory and aseptic techniques.
• Review preparation records, worksheets, calculations, equipment records, and supporting documentation for accuracy, completeness, traceability, and compliance with Good Laboratory Practices.
• Identify, document, communicate, and assist in the investigation of deviations, preparation errors, unexpected observations, equipment issues, or other events that may affect sample integrity or study quality.
• Work with Study Directors, Quality Assurance, and laboratory management to develop appropriate corrective and preventive actions when necessary.
• Ensure that personnel are appropriately trained and qualified before independently performing assigned preparation or extraction procedures.
• Develop, revise, and maintain departmental standard operating procedures, work instructions, templates, forms, and training materials.
• Maintain adequate supplies of extraction vehicles, reagents, consumables, personal protective equipment, and other materials required for departmental operations.
• Coordinate the cleaning, calibration, maintenance, and availability of departmental equipment.
• Maintain a clean, organized, secure, and inspection-ready laboratory environment.
• Monitor departmental productivity, turnaround times, errors, rework, and other performance indicators, and implement improvements where appropriate.
• Support internal audits, Quality Assurance inspections, client visits, and regulatory inspections by providing requested records and explaining departmental processes.

Perform other duties as assigned.

A bachelor's degree in toxicology, biology, chemistry, pharmaceutical sciences, or a related scientific discipline is preferred. An associate degree with significant relevant laboratory and supervisory experience may be considered.

Prior experience performing or overseeing test article extractions, sample preparations, formulation preparations, or dosing solution preparations in a regulated laboratory environment is strongly preferred. Previous supervisory or team leadership experience is required or must be demonstrated through equivalent experience.

The individual holding this position must be of the highest integrity and have a very strong sense of responsibility. He/she must be mature, well organized, capable of adapting to a broad spectrum of responsibilities and able to maintain meticulous and accurate records.   Adherence to good laboratory practices (GLP) is of utmost importance. The ability to perform basic mathematical calculations and follow detailed instructions is critical to this role.

Position is full-time, Monday - Friday, 9:00am - 5:00pm.  Candidates currently living within a commutable distance of South Brunswick Township, NJ are encouraged to apply.

The pay range of this position is $70,000 - $100,000 depending on related experience and qualification.

Excellent full time benefits including

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.