Analytical Development Scientist for Drug Analysis cGMP Lab

Germer International - Pharmaceutical Recruiting; Birmingham (AL); On-site; USD 65,000 - 90,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting is seeking an Analytical Development Scientist to perform routine and validation analyses on raw materials, in-process materials, and finished products in a cGMP setting. The role requires proficiency with HPLC/UPLC, Empower 3, and adherence to FDA/DEA/OSHA regulations, with 2–3 years in a analytical lab.

Strong data interpretation, teamwork, and communication are essential, along with familiarity with USP/NF and stability requirements.

Qualifications

• BS or MS in Chemistry, Organic Chemistry, or Biochemistry.
• Minimum of 2–3 years relevant experience in an analytical laboratory.

Responsibilities

• Perform routine, method and process validation analyses according to SOPs, cGMPs, GLP, GDP, and FDA/DEA/OSHA regulations.
• Follow regulatory guidelines and compendia pertaining to laboratory analyses, method validation, verification and transfer.
• Troubleshoot methods or instruments (HPLC/UPLC) using Empower 3 and interpret data.
• Complete projects timely to ensure safety, quality and customer service.
• Think beyond routine analysis to detect issues with methods, products, or instrumentation.

Skills

HPLC/UPLC methods

Empower 3

cGMP/GLP/GDP knowledge

Regulatory guidelines

Data analysis

Microsoft Office

Team collaboration

Education

BS or MS in Chemistry, Organic Chemistry, or Biochemistry

Tools

HPLC

GC

UV/Vis

FT-IR

Karl Fischer titrator

Dissolution Bath

Job description

Germer International - Pharmaceutical Recruiting is seeking an Analytical Development Scientist to perform routine and validation analyses on raw materials, in-process materials, and finished products in a cGMP setting. The role requires proficiency with HPLC/UPLC, Empower 3, and adherence to FDA/DEA/OSHA regulations, with 2–3 years in a analytical lab.

Strong data interpretation, teamwork, and communication are essential, along with familiarity with USP/NF and stability requirements.