Analytical Chemistry Specialist

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

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:
• Responsible for operating complex laboratory instrumentation, including HPLC, UPLC, ICP-MS, ICP-OES, GC-MS, GC-FID, IC and SEM.
• Maintain and troubleshoot issues related to complex instrumentation.
• Inventory Management: Maintain: Maintain inventory and storage of instrumentation equipment and accessories.
• Method Development & Validation:
• Assist in development of method feasibility for new products and streamline methods for existing products.
• Assist in method validation protocol generation, executing protocols, providing peer review and analysis of data.
• 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:
• 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.
• 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