Validation Manager/Director Protein Sciences
This position is responsible for facilitating oversight, evaluation and performance of all equipment, facilities, systems, utilities and product/process validation for Protein Sciences Corp. The encumbant will be the SME (subject matter expert) and help troubleshoot equiptment and product problems related to validation, conducting testing and documents results to be reviewed by leadership team and auditors and any government inspectors. Interacts with cross functional groups such as QA/QC, Regulatory Affairs and Production. This role will participate in teams with intellectual honesty, insight and a supportive manner. Effectively anticipates and communicates issues and takes action as required. Performs all activities in compliance with GMPs, SOPs, corporate policies and the highest ethical standards
1.Bachelor?s degree in science; advanced degree preferred and at least 10 years of biopharmaceutical experience with at least 5 years in a leadership role within validation.
2.Must be well organized and able to effectively span the requirements of a small company
3.Demonstrated critical analytical and evaluation skills.
4.Communicates effectively in English (written and verbal)
5.Training in validation methodologies, i.e., prospective, concurrent, and retrospective.
6.Experience in commercial operations and regulatory health inspections a plus.
7.Experience in regulated (GMP) operation
||1000 Research Parkway |
Meriden, CT 06450