Research Associate

American Regent•Brea, CA

40d•Onsite

About The Position

The Research Associate is responsible for performing analytical activities to provide support for formulation development and process development. This role involves developing methods for raw materials, in-process, and finished drug products under cGLP/cGMP, ICH, and USP/EP guidelines. The associate will perform sample testing using various analytical instruments, conduct analytical studies to support development and scale-up, and develop, modify, and optimize SOPs and test methods. Additionally, the role includes conducting literature searches, organizing sample analysis by external laboratories, troubleshooting and maintaining analytical equipment, and ensuring compliance with safety regulations and company policies.

Requirements

BS degree in pharmaceutical science, chemistry, biology, or life science related field.
Ability to work independently and collaboratively in a fast-paced laboratory environment.
Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.
The employee is required to safely handle, use, and dispose of chemicals.
Able to lift and/or move up to 50 pounds and stand on feet for approximately 4-8 hours.

Nice To Haves

Method development experience in the pharmaceutical industry.
Prior experience in pharmaceutical, analytical, or research laboratory settings.

Responsibilities

Develop methods for raw materials, in-process and finished drug product under cGLP/cGMP, ICH, USP/EP Guideline.
Perform sample testing using HPLC, UPLC, UV/VIS, GC, particle sizer, pH meter, etc. to provide support for formulation and process development.
Conduct analytical studies in support of formulation development, process development, process scale-up, and stability studies.
Develop, modify, and optimize SOPs and test methods as appropriate.
Conduct literature search for method development.
Organize and prepare samples for analysis by external laboratories.
Troubleshoot and maintain analytical equipment.
Observe and maintain compliance, safety regulations, cGLP/GMP guidelines, and company policies and procedures.
Perform any other tasks/duties as assigned by management.