Analytical Development Scientist — Pharma Method Validation

Germer International; Birmingham (AL); On-site; USD 70,000 - 90,000; Full time

Job summary

Germer International is seeking an Analytical Development Scientist to conduct routine laboratory analyses on raw materials, in-process materials, finished products and stability studies.

The role requires experience in a cGMP laboratory, regulatory awareness, and strong skills in HPLC/UPLC, instrumentation, and data interpretation. BS or MS in Chemistry with 2–3 years’ relevant experience is expected, with solid writing and communication abilities.

Qualifications

• BS or MS in Chemistry, Organic Chemistry, or Biochemistry.
• Minimum of 2-3 years relevant experience in an analytical laboratory.
• Experience in a cGMP laboratory and knowledge of FDA/DEA/OSHA regulations is preferred.
• Knowledge of USP/NF and Product Stability requirements is a plus.

Responsibilities

• Perform routine, method and process validation analyses according to SOPs and regulatory requirements.
• Follow regulatory guidelines for laboratory analyses, method validation, verification, and transfer.
• Troubleshoot methods or instruments (HPLC/UPLC) and interpret Empower 3 data.
• Complete projects timely to ensure safety, quality and customer service.

Skills

Interpersonal communication

Writing skills

Microsoft Office

Independent work

Analytical thinking

Education

BS in Chemistry

MS in Chemistry

Organic Chemistry

Biochemistry

Tools

HPLC

UPLC

GC

Karl Fischer titrator

UV/Vis

FT-IR Spectrometer

Job description

Germer International is seeking an Analytical Development Scientist to conduct routine laboratory analyses on raw materials, in-process materials, finished products and stability studies.

The role requires experience in a cGMP laboratory, regulatory awareness, and strong skills in HPLC/UPLC, instrumentation, and data interpretation. BS or MS in Chemistry with 2–3 years’ relevant experience is expected, with solid writing and communication abilities.