Scientist - Method Development

Olon USA; Concord (OH); On-site; USD 85,000 - 171,000; Full time

Job summary

Olon USA is seeking a Scientist - Method Development to join their team in Concord, Ohio. This role focuses on developing and validating HPLC procedures for pharmaceuticals within a GLP/GMP lab environment. The ideal candidate will have a strong background in chemistry and experience with analytical methods, ensuring compliance with regulatory standards.

Qualifications

• 5+ years analytical laboratory experience preferred.
• Experience in a GMP laboratory required.
• Must have basic knowledge of chemicals and safe handling techniques.

Responsibilities

• Develop and validate HPLC procedures for drug substances.
• Perform forced degradation studies and develop stability-indicating assays.
• Author and review protocols and reports.

Skills

HPLC

GC

Microsoft Excel

Communication

Multi-tasking

Education

B.S. to Ph.D. in Chemistry

Tools

Standard lab instrumentation

Job description

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• Develop and validate HPLC procedures for small molecule drug substances and drug products.
• Perform forced degradation studies and develop stability-indicating assay and impurities methods
• Work in a GLP/GMP laboratory. Coordinate the timely and compliant generation of data to support client projects.
• Perform routine HPLC, GC, NMR, MS, IR, ICP, KF and other analysis and validation studies.
• Author and review protocols and reports. Review data for technical content and accuracy.
• Maintain current expertise with relevant ICH, GMP, and FDA guidelines.
  
  

Method Development Associate Scientist/Scientist

Essential Responsibilities

• Develop and validate HPLC procedures for small molecule drug substances and drug products.
• Perform forced degradation studies and develop stability-indicating assay and impurities methods
• Work in a GLP/GMP laboratory. Coordinate the timely and compliant generation of data to support client projects.
• Perform routine HPLC, GC, NMR, MS, IR, ICP, KF and other analysis and validation studies.
• Author and review protocols and reports. Review data for technical content and accuracy.
• Maintain current expertise with relevant ICH, GMP, and FDA guidelines.
  
  

Requirements Educational Qualifications

B.S. to Ph.D. in Chemistry or related field with 5+ years analytical laboratory experience or equivalent combination of education and experience is required. Relevant experience in good manufacturing practices (GMP) laboratory is required.

Specific Skills And Requirements

• Experience with standard lab instrumentation (HPLC, UPLC, etc.)
• Experience with LCMS and GC preferred but not required.
• Be proficient Microsoft Excel and Word
• Must have basic knowledge chemicals their properties, structure, reactivity, and be able to handle with safe and appropriate techniques.
• Must have basic knowledge of arithmetic, algebra, and statistics.
• Must be able to communicate effectively with all plant and office personnel.
• Must be able to effectively multi task

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing

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