Analytical Development Chemist

Germer International - Pharmaceutical Recruiting; Birmingham (AL); On-site; USD 70,000 - 110,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting is seeking an Analytical Development Scientist responsible for routine laboratory analyses of raw materials, in-process materials, finished products, stability, and process validations related to drug product development and submission. The role requires hands-on cGMP laboratory experience and knowledge of industry regulations.

The candidate will perform method validation analyses, troubleshoot instruments (HPLC/UPLC) with Empower 3, and ensure

Qualifications

• BS or MS in Chemistry, Organic Chemistry, or Biochemistry.
• Experience in a cGMP laboratory.
• Knowledge of FDA/DEA/OSHA regulations.

Responsibilities

• Perform routine, method and process validation analyses according to SOPs, cGMPs, GLP, GDP, and FDA/DEA/OSHA regulations.
• Follow regulatory guidelines and compendia for laboratory analyses, validation, verification and transfer.
• Troubleshoot methods or instruments, HPLC/UPLC using Empower 3; analyze data from Empower 3.
• Complete projects in a timely manner to ensure Safety, Quality and Customer Service.
• Think beyond routine analysis to detect issues with the method, product, or instrumentation.
• Basic knowledge of USP/NF, Product Stability, and Process and Method validation.
• 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.

Skills

Interpersonal communication

Writing skills

Education

BS or MS in Chemistry/Organic Chemistry/Biochemistry

Tools

Empower 3

HPLC/UPLC instrumentation

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.
• 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.

Education and Experience

• BS or MS in Chemistry, Organic Chemistry, or Biochemistry.