Bioanalytical Research Scientist, CGxP Assay Testing

Job Title:

Bioanalytical Research Scientist, cGxP Assay Testing

Job Description

This onsite Bioanalytical Research Scientist role supports analytical testing for development and process-characterization projects within a regulated Bioanalytics and Analytical Operations laboratory. The scientist independently executes established analytical methods, operates and maintains laboratory instrumentation, documents work in a regulated environment, and actively contributes to the investigation and troubleshooting of unexpected analytical results.

Responsibilities

+ Perform hands-on analytical testing using modern instrumental and biochemical techniques in a regulated laboratory setting.

+ Execute analytical testing that may include moisture analysis, coagulation assays, enzymatic assays, and immunoassays according to established methods.

+ Apply volumetric, positive-displacement, and reverse-pipetting techniques to ensure precision and reproducibility of assays.

+ Operate and perform routine maintenance on laboratory instruments, which may include coulometric titrators, coagulation analyzers, immunonephelometers, and plate readers.

+ Record all laboratory activities accurately and contemporaneously in research notebooks or laboratory information management systems (LIMS).

+ Identify aberrant or unexpected results, initiate investigations, and participate actively in technical problem-solving and troubleshooting.

+ Support development and process-characterization projects by generating high-quality analytical data.

+ Contribute to data summaries and technical reports as assigned, clearly communicating methods, results, and conclusions.

+ Follow applicable laboratory procedures, standard operating procedures, and cGxP requirements at all times.

+ Use Microsoft Office applications for documentation, data organization, and communication with project teams.

+ Perform analytical work with minimal assistance, including preparation, execution, assessment, documentation, and troubleshooting of assays.

Essential Skills

+ Masters degree in Biology, Biochemistry, Chemistry, or Toxicology with at least one year of relevant experience, or a Bachelors degree in Biology, Biochemistry, Chemistry, or Toxicology with three to four years of relevant experience.

+ Demonstrated relevant analytical testing experience in a laboratory environment.

+ Strong understanding of analytical test-method principles and their application to routine and complex testing.

+ Proven ability to perform hands-on analytical assay execution rather than solely reviewing data or coordinating studies.

+ High level of precision in pipetting, including volumetric, positive-displacement, and reverse-pipetting techniques.

+ Experience documenting laboratory work in a regulated environment, including contemporaneous recording in notebooks or LIMS.

+ Ability to recognize aberrant results and contribute to investigations and troubleshooting activities.

+ Capacity to work independently with minimal assistance while maintaining high quality and compliance standards.

+ Strong laboratory documentation, organizational, and communication skills.

+ Proficiency with Microsoft Office applications for documentation and communication.

Additional

Skills & Qualifications

+ Analytical testing experience in a cGxP-regulated environment.

+

Experience with moisture analysis, coagulation assays, enzymatic assays, or immunoassays.

+ Hands-on experience with instruments such as coulometric titrators, coagulation analyzers, immunonephelometers, or plate readers.

+ Familiarity with method validation and Chemistry, Manufacturing, and Controls (CMC) development activities.

+ Experience using LIMS for sample and data management.

+ Experience contributing to laboratory investigations or technical…