Senior Analytical Chemist - cGMP & Method Transfer

Stokes Pharmacy; Mount Laurel Township (NJ); On-site; USD 120,000 - 150,000; Full time

Job summary

Stokes Pharmacy is seeking a senior analytical chemist to support cGMP analytical chemistry activities including routine testing, stability testing and method transfer. You will test Finished Product, R&D Materials, Stability Samples, and Raw Materials in a regulated lab environment.

The role requires a Bachelor's in chemistry, 10 years in pharmaceutical analytics, experience with HPLC/UPLC (Empower 3 preferred), GMP/FDA/ICH/OSHA knowledge, and strong attention to detail.

Qualifications

• Bachelor’s degree in chemistry or a relevant field.
• Minimum 10 year of experience in pharmaceutical industry performing analytical testing
• Experience with HPLC/UPLC analysis, preferably using Empower 3 software
• Familiar with general laboratory instrumentation and equipment: Karl Fischer, micropipettes, pH meter, analytical balance, vortex, centrifuge, volumetric glassware etc.
• Familiar with GMPs, FDA, ICH and OSHA requirements
• Experience using MS word, Excel, and/or relevant applications
• Must be capable of wearing all protective wear as required by regulations/company standards. This includes, but not limited to; mask, gloves, gown, respirator, safety goggles etc.
• Must be capable of working with small delicate pieces of machinery to complete appropriate analysis in a timely manner
• Must be able to work with chemicals used in sample analysis including acids, bases, and solvents following any special safety precautions as required.
• Must have strong organizational skills and exceptional attention to detail
• Must exhibit punctuality and low absenteeism

Responsibilities

• Perform analytical testing of Finished Product, Research and Development Materials, Stability Samples, and Raw Materials
• Ensure testing is performed in accordance with cGMP, USP, ICH, FDA and company standards
• Review and approve analytical testing data
• Lead investigations
• Authors/revises SOPs, protocols and data reports
• Tracks and trends data
• Performs method transfer
• Lead qualification and calibration of equipment

Skills

Analytical testing

cGMP compliance

HPLC/UPLC analysis

Empower 3

Lab instrumentation

GxP knowledge

MS Word

Safety protocols

Problem solving

Attention to detail

Education

Bachelor's degree in chemistry

Tools

Karl Fischer

pH meter

Analytical balance

Job description

Stokes Pharmacy is seeking a senior analytical chemist to support cGMP analytical chemistry activities including routine testing, stability testing and method transfer. You will test Finished Product, R&D Materials, Stability Samples, and Raw Materials in a regulated lab environment.

The role requires a Bachelor's in chemistry, 10 years in pharmaceutical analytics, experience with HPLC/UPLC (Empower 3 preferred), GMP/FDA/ICH/OSHA knowledge, and strong attention to detail.