Manager/Senior Manager, Quality Control - Microbiology

The role

This person will manage the Microbiology laboratory, personnel, and the site Environmental and Personnel Monitoring program. They will oversee testing for in-process samples, drug substance, drug product, and complaint samples while ensuring compliance with cGMP/GMP policies.

What you will do

• Maintain a safe, efficient, functional, and compliant laboratory operation in accordance with GMP SOP’s, guidelines and regulations.
• Coordinate day-to-day management of QC Microbiology operations.
• Manage and develop the performance of direct reports.
• Oversee testing in-process samples, drug substance and drug product release/stability and complaint samples.
• Oversee performance of environmental and utility monitoring.
• Maintain data integrity to the highest industry standards.
• Oversee timely investigation of OOS, OOT, and other laboratory exceptions.
• Manage outsourced testing activities.
• Develop, maintain, and continuously improve robust QC systems.
• Support and participate in internal and external inspections and audits.

Required qualifications

• BS in Microbiology/ Biology, or related scientific discipline
• At least 8 years’ GMP Quality Control experience
• At least 4 years management experience
• Advanced knowledge of global, especially US and EU GMP guidelines
• Strong leadership in team management, decision making, change management, collaboration, delivering desired business results, and ability to influence
• Confident, independent, self-starter, proactive, and results-oriented with high performance and compliance standards
• Strong ability to prioritize and operate with a sense of urgency
• Solid organizational, analytical, and problem-solving skills
• Effective communication skills with the ability to interact with all levels of the key stakeholder
• Demonstrated ability to effectively solve problems and implement practical solutions in a dynamic and innovative environment
• Strong operational and business acumen
• Exhibits highest integrity and committed to ethics and compliance standards

Nice to have

• Open and transparent in sharing data and information

Benefits

• Paid vacation days, amount based on tenure
• Paid sick time
• 10 observed holidays + 2 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance
• Accidental Death & Dismemberment (AD&D) Insurance

Before you apply

• Criminal background check required
• Drug screen required
• Not able to sponsor visas

About the company

Genezen provides process development, produces GMP viral vectors, and provides cell transduction for gene and cell therapy clinical trials. The company seeks innovative, collaborative problem solvers to meet the needs of the growing gene therapy field.