Validation Manager Biotech Extraordinaire!

Do you want to get in on the ground floor for a Bio-pharmaceutical upstart with 2 commercialized products and a strong pipeline? Do you want to build a Validation group the way you want it to be vs. dealing with what you have?

Growth orientated Maryland Company in the heart of the Chesapeake Bay region (a stone’s throw from the bay) is looking for a hands-on, self-starting, organization builder to run their Validation Department. You’d be responsible for developing the Master Validation Plan for the company, working with outsource partners (CMO’s, CRO’s etc) on their validation programs and interfacing with the FDA and EU vis-à-vis validation and vendor qualification. Reporting to the Director of Quality Assurance you would have full reign to develop the Corporate Validation Program.





Requirements
•80% of the job will be developing the MVP, process validation, facility, utility and equipment qualification
•20% of the job will be analytical method validation, part 11 and cleaning validation (not initially)
•5-8 years in biotech, pharma or biomedical industry
•3-5 years supervisory experience
•3-5 years experience interfacing with FDA/EU
•Hands-on, no politics, self starter
•BS Chemistry, Biology, Engineering or related field
•Travel 50-70% (visiting outsource partners in US)

Qualified, interested candidates should send a confidential word format resume. This opportunity will not last.