Description:

This position is intended to provide analytical test method development, validation, and transfer support for the quality and stability laboratories. It will entail specific chemical and physical analyses on new and existing pharmaceutical (drug) substances and products through all stages of the manufacturing process from incoming raw materials, in-process assays, finished product release testing, and stability studies.

1. Conduct critical chemical and physical analyses upon raw materials; on initial, in-process and final products; supporting stability studies; and samples collected from cleaning or environmental monitoring programs at the manufacturing facility.

2. Use a variety of laboratory instrumentation with a focus on chromatographic techniques.

3. Computer proficiency allowing for the use of word processing and spreadsheets, and to collect and record data, e.g. Empower, and electronic laboratory notebooks (eLN).

4. Perform assays requiring precise analytical skills and understanding of chemistry principles.

5. Complete all testing, including special project / protocol testing in a timely and appropriate manner while maintaining data integrity and ensuring compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.

6. Draft or revise protocols, reports, SOPs, and supporting documents as necessary.

7. May perform equipment maintenance and calibrations as required.

Skills:

HPLC, Wet Chemistry, Laboratory, FDA, UV-Vis, pH, Titrations, GC, Chromatography, Analytical Chemistry, Empower, GMP

Top Skills Details:

HPLC,Wet Chemistry,Laboratory

Additional Skills & Qualifications:

Required:

• Bachelor’s Degree in Chemistry, or in Biological Sciences including Analytical Chemistry Laboratory coursework with 0-2 years experience in a GMP laboratory environment.

• Knowledge of HPLC or GC, and Wet Chemistry

• Knowledge of Empower CDS and LIMS is preferred but not required

• Knowledge of FDA GLP, cGMP requirements and familiar with USP/ICH guidelines is preferred but not required

Experience Level:

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.