13 Sep
Production Chemist (Carlsbad)
California, San diego 00000 San diego USA

Vacancy expired!

Qualigen (www.qualigeninc.com) is a biotechnology company focused on the development and commercialization of novel therapeutic products for the treatment of cancer and infectious diseases, as well as expansion of its flagship FastPack® diagnostic platform. The FastPack® line of FDA-cleared and CE-Marked products has been used successfully in diagnostics since 2002. Our therapeutics pipeline includes cancer drug compounds such as AS1411, ALAN, and RAS-F, as well as STARS, a DNA/RNA-based treatment device. By combining our demonstrated ability to quickly develop and commercialize innovative medical products with the advanced capabilities of leading cancer research centers, such as the University of Louisville, we are committed to providing exciting new therapeutic and diagnostic technologies to physicians and patients. Come join our team of talented people!

Position Reports To: VP R&D

Position Summary: Responsible for the formulation of kit components including bulk reagents according to written manufacturing instructions.

Responsibilities:

· Responsible for all aspects of reagent formulations including:

o Formulation and preparation of buffers, diluents, enzyme conjugations to proteins, biotinylation, calibrator/control preparation, paramagnetic microparticle solutions and other solutions/matrices.

o Evaluation of raw materials and in process testing

o Preparation of jobs based on the production schedule and initiating work orders

o Completing batch record documents and generating NCMRs and deviation reports as needed

o Maintaining lab equipment, wash glassware, and keep lab area clean

o Chemical inventory maintenance and perform raw materials cycle counts

o Order lab supplies and ensure any materials and equipment are available and in working order to complete jobs

· Additional responsibilities include but are not limited to:

o Filling and labeling operations

o In-process inspections and testing

o May support troubleshooting, investigation, and/or QC/R&D efforts

o SOP revision and change control processes.

Preferred Skills:

Education: B.S. degree in life sciences or chemistry

Experience: 2+ years experience in reagent manufacturing under FDA / GMP regulations.

Good working knowledge of chemistry/biochemistry and basic mathematics

Good laboratory skills including laboratory safety, equipment operation and maintenance

Good understanding of FDA regulations and GMP compliance

Excellent documentation skills

Ability to multi-task, handling multiple builds simultaneously.

Proficient in MS Word, Excel and PowerPoint.

Vacancy expired!


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