Analytical Chemistry Specialist: Method Dev & Instrumentation

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

Job summary

BioSpectra, Inc. is seeking an Analytical Chemistry Specialist to oversee all stages of method implementation from development and validation to routine analysis. The role includes bringing new instrumentation online and streamlining existing methods.

The ideal candidate has 1–3 years of experience in a QC or cGMP laboratory with skills in LC, ICP and GC instrumentation, and will participate in organic impurity analyses and regulatory support.

Qualifications

• A minimum of one to three years of experience in a quality control and/or cGMP laboratory with knowledge of operating LC, ICP and GC instrumentation in a GMP laboratory.
• Experience in the pharmaceutical or related industry in a laboratory setting with knowledge of cGMP and related compliance regulations.
• Ability to perform data analysis, complex analytical calculations and statistical analysis.
• Ability to train QA Analysts on instrument analysis and to write analytical protocols and reports.
• Experience performing organic impurity analysis.

Responsibilities

• Operate complex laboratory instrumentation (HPLC/UPLC, ICP-MS, GC-MS, GC-FID, IC and SEM).
• Maintain and troubleshoot issues related to instrumentation.
• Assist in method development feasibility for new products and streamline existing methods.
• Assist in method validation protocol generation and data analysis.
• Support OOS investigations by processing and interpreting data.
• Serve as instrument-analytical methods subject matter expert.
• Train QC Analysts to perform analyses on complex instrumentation.
• Perform organic impurity analysis to support regulatory submissions.
• Source and qualify reference standards for analysis.
• Perform routine testing and review of instrument performance.

Skills

Data analysis

Statistical analysis

Instrument training

Analytical protocol writing

Education

Bachelor's degree in Science

Tools

HPLC/UPLC

ICP-MS

ICP-OES

GC-MS

GC-FID

IC

SEM

Job description

BioSpectra, Inc. is seeking an Analytical Chemistry Specialist to oversee all stages of method implementation from development and validation to routine analysis. The role includes bringing new instrumentation online and streamlining existing methods.

The ideal candidate has 1–3 years of experience in a QC or cGMP laboratory with skills in LC, ICP and GC instrumentation, and will participate in organic impurity analyses and regulatory support.