Analytical Development Scientist - CGMP & Validation

Sigmapharm Laboratories, LLC; Bensalem Township (Bucks County); Hybrid; USD 52,000 - 68,000; Full time

Job summary

Sigmapharm Laboratories, LLC in the United States is seeking a laboratory professional to perform physical and chemical testing across raw materials, in-process, release, and stability samples. You will record data, analyze results, and support development to approval for ANDA/NDA projects under CGMP guidelines.

The role requires familiarity with analytical instruments (HPLC, GC, Dissolution, UV-VIS, IR) and strong data interpretation, documentation, and teamwork within a regulated QC

Qualifications

• BS in Chemistry or Pharmaceutical sciences with 1–3 years of relevant laboratory experience.
• Experience with CGMPs and regulated environments.
• Ability to perform routine/new procedures with minimal supervision.

Responsibilities

• Perform physical and chemical testing of raw material, packaging material, in-process, release, and stability samples.
• Record experimental data, analyze results, and maintain notebooks.
• Support ANDA/NDA projects from development to approval with guidance.
• Assist in maintaining the laboratory in compliance with SOPs, CGMPs, FDA and OSHA.
• Use and maintain instruments such as HPLC, GC, Dissolution, UV-VIS, IR, Titrator, etc.
• Troubleshoot and perform minor maintenance and repair of lab instrumentation.
• Assist in writing technical documents (specifications, test methods, protocols and reports).

Skills

Communication skills

General Chemistry knowledge

Multi-tasking / prioritization

CGMP experience

Technical terminology understanding

Data analysis / plotting

Education

BS in Chemistry or Pharmaceutical sciences

Tools

HPLC

GC

Dissolution

UV-VIS

IR

Titrator

Job description

Sigmapharm Laboratories, LLC in the United States is seeking a laboratory professional to perform physical and chemical testing across raw materials, in-process, release, and stability samples. You will record data, analyze results, and support development to approval for ANDA/NDA projects under CGMP guidelines.

The role requires familiarity with analytical instruments (HPLC, GC, Dissolution, UV-VIS, IR) and strong data interpretation, documentation, and teamwork within a regulated QC