Responsibilities of this position:

·                 Manage the day to day activities of a commercial manufacturing group.

·                 Provides technical expertise and resources for the validation of both equipment and process. May lead actual process validation activities.

·                 Ensures compliance with all appropriate Federal Drug Administration (FDA) and other regulatory agency guidelines.

·                 Typically develops SOPs and batch records to support GMP manufacturing.

·                 Collaborates with Quality to ensure that all, products are manufactured according to specifications and are released in a timely manner.

·                 Provides commercial manufacturing input into failure investigations, deviations and CAPAs.

·                 Supervises employees, responsible for performance reviews and employee development. Participates in recruiting and training.

·                 Responsible for observing all Company, Health Safety and Environmental guidelines.