Description:
Pacific BioLabs is an independent CRO providing cGMP/GLP testing in toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology. We are currently hiring to support our clients in the pharmaceutical, biotech, and medical device fields. Join us in our mission to improve public health through science!
Pacific BioLabs is seeking a detail-oriented and technically skilled Test Article Preparation Specialist who will support both in vivo, in vitro, and chemistry laboratory testing by preparing a variety of samples for analysis. This role involves handling and preparing samples such as but not limited to medical devices, patches, pharmaceutical packaging, and container closure systems. Key duties involve solvent extraction (sonication, incubation etc.), solvent evaporation, sample dilution and aliquoting, and precise, clean-handling techniques to prevent cross-contamination. The TA Specialist will ensure accurate sample preparation, maintain laboratory organization and document all activities in compliance with applicable regulatory guidelines.
This position plays a critical part in the biocompatibility and analytical testing pipeline for medical devices. The Test Article Preparation Specialist is responsible for preparing device samples and performing chemical extractions that feed directly into in vitro and in vivo testing protocols. Working closely with testing laboratories, the specialist must maintain precise timelines and meticulous documentation to support regulatory submissions. The role requires a strong foundation in chemistry or biological sciences, an eye for detail, and the ability to follow complex written protocols with consistency and accuracy.
PRIMARY RESPONSIBILITIES FOR THE TEST ARTICLE PREPARATION SPECIALIST INCLUDE
Sample Preparation
-
Prepare samples by performing cutting, weighing, rinsing, mixing, extracting and sterilization procedures in accordance with established protocols.
-
Ensure all samples meet dimensional, surface, and sterility requirements prior to submission for testing.
-
Perform samples dilutions and aliquoting using clean-handling techniques to prevent cross-contamination. When applicable, ensure all samples meet sterility requirements prior to submission for testing. Ensure accurate sample identification throughout the preparation process.
Extraction & Chemical Analysis
-
Conduct solvent feasibility studies and perform extractions for chemical characterization and biocompatibility evaluations per ISO 10993-18.
-
Perform non-volatile residue (NVR) analysis for exhaustive extractions to support chemical characterization studies.
Documentation & Regulatory Compliance
-
Following ALCOA++ principles, accurately document all sample preparation steps, observations and test results.
-
Prepare and report test results summaries to scientists.
-
Maintain accurate SDS documentation.
Laboratory Maintenance & Operations
-
Clean, maintain and calibrate basic laboratory equipment (incubators, ovens, balances, pH meters, rotary evaporators) to prevent contamination and ensure proper operation.
-
Prepare chemical solutions.
-
Prepare and maintain sterile glassware and consumables required for the sample preparation process.
-
Organize and restock the prep lab to maintain an efficient, clean, and safe work environment.
-
Train new staff in procedures, equipment operation and safe chemicals and samples handling.
Study Coordination & Timeline Management
-
Support laboratory analysts by ensuring samples are prepared and delivered according to project timelines.
-
Proactively communicate any deviations, delays, or issues that may impact study schedules.
Safety & Compliance:
-
Follow laboratory safety procedures and protocols for proper samples storage, handling and disposal.
-
Ensure appropriate Personal Protective Equipment (PPE) is always worn.
Requirements:
QUALIFICATIONS AND SKILLS FOR THE TEST ARTICLE PREPARATION SPECIALIST
-
Bachelor of Science (B.S.) in Biology, Chemistry, Biomedical Engineering, or a closely related field.
-
1–5 years of hands-on experience in a laboratory setting, with preference for medical device testing or regulated laboratory environments.
-
Working knowledge of ISO 10993 standards, including ISO 10993-1 (risk framework), ISO 10993-18 (chemical characterization), and ISO 10993-23 (irritation testing).
-
Familiarity with USP sample preparation techniques applicable to pharmaceutical container closure and/or single use manufacturing components.
-
Experience with analytical chemistry techniques and/or biocompatibility testing methodologies.
-
Demonstrate ability to prepare solutions, perform serial dilutions, and concentrate samples following written protocols.
-
Strong attention to detail with the ability to maintain accurate records in a GMP/GLP-compliant environment.
-
Knowledge of chemical handling and hazardous material disposal.
-
Ability to handle multiple samples and multitask in a fast-paced environment.
-
Ability to work collaboratively with other lab personnel.
PREFERRED QUALIFICATIONS AND SKILLS FOR THE TEST ARTICLE PREPARATION SPECIALIST
-
Experience operating rotoVaps, incubators, analytical balances, or other standard laboratory instrumentation.
-
Exposure to FDA regulatory submissions or experience supporting preclinical or ISO-compliance testing programs.
-
Familiarity with ALCOA++ data integrity principles in a regulated laboratory context.
The base pay offered for this position is $65,000 to $85,000 and will take into account internal equity and may also vary depending on the candidate’s job-related knowledge, skills, and experience among other factors. This position will be eligible for medical, dental, vision, life insurance, 401k, and other benefits.
PBL is an equal opportunity employer committed to diversity and inclusion. PBL considers all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veterans’ status, or any other legally protected factors.
