Job Introduction

Role Responsibility

• Leading and directing the Microbiology department, providing hands-on guidance and support to ensure the team is successful in meeting their objectives.
• Developing and implementing learning and development opportunities for team members to enhance their skills and abilities.
• Making informed quality decisions related to non-sterile and Aseptic Processing across various areas such as manufacturing, facility design, certification & maintenance, investigations, documentation, CAPA, change control, and regulatory compliance.
• Ensuring timely initiation and closure of documentation related to deviations & investigations, CAPAs, change controls, SOPs, with standardized supporting documentation.
• Establishing and enforcing effective SOPs and training documents to promote consistency and compliance within the team.
• Oversees execution of testing including routine lot related analysis, environmental monitoring and raw material testing. Generation and approval of certificates of analysis for product release.
• Leads development, implementation, enhancement and maintenance of QC Microbiology systems.
• Evaluating QC Microbiology systems and recommending and/or implementing system improvements and CAPEX projects.
• Responsible for the QC Microbiology and Aseptic Techniques Training programs.
• Conducting laboratory investigations and writing reports for deviations, Environmental Monitoring excursions, and Out of Specification results.
• Oversee the Environmental Monitoring Program, reviewing EM data, EM excursion investigations and EM reports.
• Ensuring that development and implementation of testing programs meet departmental, company, and regulatory compliance requirements.
• Taking ownership of multidepartment projects (identifying tasks, assigning responsibilities and timelines, and ensuring timely completion of projects).
• Developing effective partnerships with other departments to facilitate problem solving and resolution of issues.
• Coordinates with operations and supply management team for scheduling and test material availability to meet production demand and timely delivery of finished goods to distribution.
• Provides guidance to subordinates to achieve goals in accordance with established company goals and objectives.
• Develop and maintain internal KPI’s to demonstrate department performance.
• Writing/revising test methods and SOPs. Writing and reviewing QC technical protocols and reports.
• Develops, revises and reviews investigations, SOPs, qualification/validation protocols and reports
• Manage QC files and Environmental Monitoring electronic databases.
• Evaluate electronic database systems for implementation into QC.
• Effectively communicates with other departments and/or internal groups.

The Ideal Candidate

• Degree in Microbiology field with a minimum 5 years of cGMP QC Microbiology experience in a cell therapy/biotech/pharmaceutical setting is required.
• Excellent critical thinking and technical writing skills.
• Ability to work effectively and efficiently on independent tasks as well as to accept direction on given assignments or in a team environment.
• A minimum of 2 years of management experience including leading, motivating, and developing technical staff.
• 5 years Environmental Monitoring experience is required.
• Demonstrated ability to apply comprehensive understanding of QC guidelines, regulations, and current industry practices, including cGMPs and aseptic processing guidelines.
• GMP instrument qualification/validation experience.
• Experience with FDA cGMP manufacturing processes.

Dechra Pharmaceuticals PLC