Analytical Scientist

Germer International - Pharmaceutical Recruiting; Birmingham (AL); On-site; USD 65,000 - 95,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting is seeking an Analytical Development Scientist in Birmingham, AL to perform routine and method validations under cGMP constraints, analyzing raw materials through finished products.

The role requires hands-on experience with HPLC/UPLC, Empower 3, and regulatory compliance, along with strong writing and teamwork in a quality-focused environment.

Qualifications

• BS or MS in Chemistry, Organic Chemistry, or Biochemistry.
• 2–3 years relevant experience in an analytical laboratory.
• cGMP/GLP knowledge preferred.
• Ability to work in a regulated environment.

Responsibilities

• Perform routine, method and process validation analyses according to SOPs, cGMPs, GLP, GDPs, and FDA/DEA/OSHA regulations.
• Follow regulatory guidelines and compendia pertaining to laboratory analyses, method validation, verification, and transfer.
• Troubleshoot methods or instruments, HPLC and/or UPLC, using Empower 3 software and interpret data.
• Complete all projects in a timely manner to ensure Safety, Quality and Customer Service.

Skills

HPLC/UPLC

Empower 3

Regulatory knowledge

Data analysis

Writing skills

Microsoft Office

Teamwork

Education

BS or MS in Chemistry/Organic Chemistry/Biochemistry

Tools

HPLC

Dissolution Bath

GC

Karl Fischer titrator

UV/Vis

FT-IR Spectrometer

Job description

The Analytical Development Scientist is responsible for routine laboratory analysis of raw materials, in-process materials, finished products, stability and process validations associated with the development and submission of drug products. The candidate must demonstrate experience working in a cGMP laboratory and possess broad knowledge of industry regulations related to pharmaceutical analytical analysis.

Core Responsibilities

• Perform routine, method and process validation analyses according to company established Standard Operating Procedures (SOP’s), Current Good Manufacturing Practices (cGMP’s), Good Laboratory Practices (GLP’s), Good Documentation Practices (GDP’s), as well as FDA/DEA/OSHA regulations.
• Follow regulatory guidelines and compendia pertaining to laboratory analyses, method validation, verification, and transfer.
• Troubleshoot methods or instruments, HPLC and/or UPLC, using Empower 3 software. Must be able to analyze and interpret data from Empower 3.
• Complete all projects in a timely manner to ensure Safety, Quality and Customer Service.

R&D Specific Requirements

• Ability to think beyond routine analysis of samples to detect issues with the method, product, or instrumentation.
• Basic knowledge of USP/NF, Product Stability requirements, and Process and Method validation.
• Ability to integrate into team-based projects.
• Experience with laboratory instrumentation such as HPLC, Dissolution Bath, GC, Karl Fischer titrator, UV/Vis, and FT-IR Spectrometer.
• Strong interpersonal communication and writing skills.
• Competency in Microsoft Office Suite.
• Ability to work under minimal supervision.

Physical Requirements

• Ability to wear personal protective equipment (safety glasses, respirator, gloves, etc.).
• Ability to stand for long periods of time.
• Ability to lift/carry 10–15 lbs.

Education and Experience

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