Key Responsibilities Include:

• Performs test methods validations for clinical and commercial projects.

• Understands and maintains a safe work environment for themselves and others in accordance with procedural requirements.

• Understands, implements and maintains cGMP with respect to laboratory records, procedures and systems in accordance with procedural requirements.

• Performs a multitude of laboratory techniques for which they are trained.

• Accepts responsibility to complete assigned tasks within required timelines and works with others to accomplish business objectives.

• Authors validation protocols and reports as well as corresponding test methods.

• Support laboratory investigations in a timely manner.

• Support a variety of testing techniques upon completion of training.

Basic:

• BA/BS in Chemistry, Biochemistry, Medical Technology, Biology or equivalent science degree and 2+ years of related work experience.

• CE-SDS, HPLC or ELISA existing experience and troubleshooting experience

• Empower or Softmax / PLA software experience

Preferred:

• Spectrophotometric concentration determination

• Quality Control testing of phase III and commercial products

• Experience with empower audit trail