Pharma Analytical Development Scientist - HPLC & Validation

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

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