Associate Director, Quality Control

This is an exciting new opportunity to work within an expanding US Biologics Contract Manufacturing Organization with an extensive network of cGMP facilities in the US, Europe and Asia. It's also an exciting opportunity to lead major growth efforts due to new client acquisitions and facility expansion projects.

This is a stellar opportunity to provide leadership for GMP analytical testing for clinical and commercial products. Your team will be responsible for method validation, transfer activities and specification setting associated with QC testing of our GMP products. The roles and responsibility will include:

* Leading a team of employees responsible for QC Biochemistry, in-process, lot release, and stability testing of therapeutic bulk drug substance and final drug product laboratories.

* Leading QC testing, methods development, and characterization including IEF, SDS PAGE, Western Blot, GC, UV, HPLC, Capillary Electrophoresis (CE), and UV & IR spectroscopy.

* Leading analytical methods development, methods qualification, and methods validation activities.

* Leading QC related technical troubleshooting including deviation handling and investigations.

* Ensuring (Pre-Approval Inspection) PAI readiness, hosting FDA & EMEA audits and inspections.

* Implementing and maintaining LIMS and Laboratory Quality Systems.

Minimum Requirements:

* BS in related scientific field, advanced degree preferred.

* Advanced skills and experience in QC.

* Experienced hands-on knowledge in management or leadership role.

* Proven experience developing budgets, monitoring, and escalating variances.

* In-depth understanding of concepts and principles in own discipline and basic knowledge of how these elements apply in other areas.

* Working knowledge of aseptic processing, environmental/utility monitoring, clean room qualification, and microbiological testing required.

* Maintains up to date knowledge of new technologies and potential applications.

* Knowledge of how to execute team methods/procedures and operate equipment, and ability to support analyst tasks on a non-routine basis.

* Knowledge of SAP and TrackWise systems a plus.

* Ability to use experience to problem solve, make decisions, and make plans to improve departmental strategies.