Analytical Development Scientist

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

Job Function Summary:

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.