Analytical Chemistry Specialist

Socket.dev; Bangor (Northampton County); On-site; USD 65,000 - 90,000; Full time

Job summary

BioSpectra is seeking an Analytical Chemistry Specialist to lead method development, validation, and routine analysis in a GMP laboratory. The role focuses on bringing new instrumentation online, troubleshooting advanced systems, and training QC analysts to operate LC, ICP, and GC technologies.

You will contribute to analytical report generation, organic impurity analyses for regulatory submissions, and instrument qualification activities to ensure data integrity and compliance with cGMP

Qualifications

• Must be able to perform data analysis, complex analytical calculations and statistical analysis.
• Must be able to train QA Analysts on instrument analysis.
• Must have prior experience writing analytical protocols and reports.
• Must have prior experience performing organic impurity analysis.

Responsibilities

• Oversee method development and validation for new products and streamline existing methods.
• Operate and troubleshoot complex instrumentation (LC, ICP, GC) and maintain compliance in a cGMP environment.
• Train QA Analysts to perform analyses on advanced instrumentation.
• Support regulatory submissions with organic impurity analysis data and report generation.

Skills

Data analysis

Instrument training

Analytical protocols

Organic impurity analysis

Education

Bachelor's degree in Science

Tools

LC

ICP

GC

Job description

Job Overview

This position plays an important role in BioSpectra’s Laboratory Services department. The position is responsible for all stages of method implementation from method development and method validation to routine analysis. The Analytical Chemistry Specialist will be responsible for instrumentation development work, which includes getting new instrumentation online and operational while streamlining existing methods.

This position would be ideal for an analytical chemistry professional who is seeking a challenging opportunity with a growing Bio-Pharmaceutical Company.

Key Responsibilities

Laboratory Instrumentation

1. Responsible for operating complex laboratory instrumentation, including HPLC, UPLC, ICP-MS, ICP-OES, GC-MS, GC-FID, IC and SEM.
2. Maintain and troubleshoot issues related to complex instrumentation.

Inventory Management

• Maintain inventory and storage of instrumentation equipment and accessories.

Method Development & Validation

1. Assist in development of method feasibility for new products and streamline methods for existing products.
2. Assist in method validation protocol generation, executing protocols, providing peer review and analysis of data.
3. Assist in report generation regarding instrumentation.

Out of Specification Investigations

• Assist in out-of-specification (OOS) result investigations by processing/interpreting data, conducting analysis and evaluating instrumentation.

Instrumentation Analytical Method Expertise

• Function as an analytical subject matter expert for instrument analytical methods.

Analyst Training

• Train QC Analysts to perform analysis on complex instrumentation.

Organic Impurity Analysis

• Perform organic impurity analysis to support regulatory submissions.

Reference Standards

• Source and qualify, when applicable, reference standards for analysis.

Routine Testing and Analysis

• Perform analysis and review of routine instrument testing.

Skills & Qualifications

• Education: Bachelor's degree in Science or related field, and/or commensurate experience.
• Experience:
  1. A minimum of one to three years of experience in a quality control and/or cGMP laboratory, with demonstrated knowledge and experience operating LC, ICP and GC instrumentation in a GMP laboratory.
  2. Experience in the pharmaceutical or related industry in a laboratory setting, with knowledge of cGMP and related compliance regulations.
• Skills & Capabilities: The ideal candidate will have demonstrated the following abilities:
  • Must be able to perform data analysis, complex analytical calculations and statistical analysis
  • Must be able to train QA Analysts on instrument analysis
  • Must have prior experience writing analytical protocols and reports
  • Must have prior experience performing organic impurity analysis