Requirements

• Bachelor's degree in Microbiology, Biology, Chemistry or related scientific discipline.

• Master’s degree in the relevant fields is strongly preferred.

• 10+ years of laboratory experience in cGMP regulated environment.

• 4+ years of medical device experience.

• 5+ years of supervisory or managerial experience.

• Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:2007.

• Working knowledge of FDA requirements as per 21 CFR 820.

• Working knowledge of Good Documentation Practices (GDP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (cGMP).

• Experience should include method development/validation and/or transfer/verification, protocols, and trouble shooting skills.

• Requires understanding of microbiology testing, analytical testing, and quality principles as applied to a cGMP environment. This includes experience in raw material, in-process and finished product testing, e.g. bioburden, endotoxin studies, sterility assurance, appearance, cleaning methods, HPLC and rheometer.

• Proficient in the use of Microsoft Excel and Microsoft Word.

• Requires strong leadership skills, excellent communication and presentation skills.