Sr Manager Microbiology Laboratory

Purpose

Ensures quality control and environmental control compliance across the manufacturing site. Create and implement environmental programs and policies, oversee the organization's environmental performance, and ensure the organization is complying with regulations and requirements of environmental control policies. Serves as an integral member of site leadership team with a focus on ensuring quality environmental requirements are achieved.

Responsibilities

• Lead the biologics site micro laboratory process for a high volume, high level of product complexity including multi products to ensure compliance with regulations including EU Annex 1, ISO, WHO, FDA Guidelines for Aseptic Processing, among others. Ensure robustness and approves Investigations Microbiology EM, quality and process excursions or incident.
• Direct MEC laboratory operations such as micro methods for in process, finished product, and stability, microbiological...