Oversee microbiological testing activities for several of the following functions but not limited to raw material, component, drug product, stability, validation, investigational, in-process testing, etc.

Oversee environmental monitoring, aseptic process simulation and gowning qualification programs.

Serve as a subject matter expert for microbiology.

Lead, guide, and mentor analysts

Foster a culture of continuous improvement.

Ensure the laboratories are clean, organized, compliant, and audit ready always.

Support formulation, process development, and scale-up activities

Review and approve laboratory data for accuracy and completeness.

Lead and serve on cross-functional project teams.

Prepare protocols, technical reports, and other documentation for CMC related activities.

Identify and resolve project-related issues that have the potential to impact project deliverables.

Ensure compliance of laboratory personnel and equipment

Prepare annual laboratory budgeting.

Perform annual performance assessments of direct reports.