Supervisor of Quality Control (Microbiology)

College Station, TX

Introduction

A CDMO that specializes in the production of cell/gene therapies is looking to grow their team. Their main goal is to create solutions for their clients and expediting the path to a regulatory approval.

As the Supervisor of Quality Control you will act as a subject matter expert with regard to Quality Control Microbiology practices and procedures and serves as the main point-of-contact for all QC Microbiology activities. You will be responsible for planning, scheduling, and organizing QC Microbiology activities related to meeting the compliance, supply, profit plan and strategy objectives of the company and the department.

This role will offer you

• The opportunity to join a growing, dynamic, and innovative science company
• Desirable working environment with career growth opportunities
• Great benefits and annual bonus
• Competitive Salary

You will be responsible for

• Creation of all QC Microbiology quality systems and implementation of those systems.
• Coordinating the Quality Control Microbiology Budget
• Participation in internal audits, client audits and agency inspections of the site
• Support internal and external cGMP manufacture and supply of high-quality cell and gene therapy products including oversight of cGMP sample handling, testing, QC release
• Developing, implementing and monitoring QC Microbiology programs and procedures to ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelines

You will bring the following

• BS in related life sciences area, preferably in chemistry, biochemistry, microbiology, biotechnology, pharmaceutical sciences
• 8+ years related GMP experience in microbiology, pharmaceutical, manufacturing or laboratory environment
• Expert knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
• SME in QC Microbiology

For more information about this opportunity, please apply to the role directly or send an email to ariana.lopezcuevas@biotalent.com.