QC Scientist - Critical Reagents

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. 

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

JOB SUMMARY

The QC Scientist - Critical Reagents is responsible for overseeing all reference standards and other critical reagents in line with internal SOPs and ICH guidelines. This individual will work collaboratively with QC Operations, Analytical Development, and Quality Assurance in support of clinical pipeline and commercial products. This position requires strong leadership skills, statistical and technical knowledge, and a commitment to quality and compliance

ESSENTIAL JOB FUNCTIONS

• Oversee the Critical Reagents and Materials function.
• Oversee the day-to-day operations of the GC QC Technical Services group.
• Provided operational oversight for critical reagent and materials management across the quality organization.
• Develop and maintain robust systems for the qualification, monitoring, tracking and storage of critical reagents and materials.
• Collaborate with cross-functional groups to ensure the continued supply of qualified reagents and materials.
• Act as the primary point of contact for the monitoring, tracking, and storage of critical reagents and materials.
• Manage inventory, strategic planning, and lifecycle management of reference standards and critical materials.
• Represent Quality Control on project teams and in meetings as required.
• Authors and reviews standard operating procedures, protocols, and reports as required.
• Manages the implementation/maintenance/continuous improvement of Quality Systems as required. 

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

BS or MS in Life Sciences or Engineering

Essential

ON-THE-JOB EXPERIENCE

 

8+ years of pharma/biotech industry experience

Essential

Well versed in cGMP/ICH/FDA/EU regulations and guidelines 

Essential

Large molecule, gene or cell therapy experience is required. 

Essential

Expertise in reference standards programs, including ICH regulations and quality control methods. 

Essential

Strong background in biostatistics for evaluation comparability and qualification of new reference standards and control reagents. 

Desired

Experience in Quality Control within the biological pharmaceutical industry. 

Desired

Proficiency in writing SOPs, qualifications protocols, and reports. 

Essential

Familiarity with statistical software (JMP).

Essential

SKILLS / ABILITIES

 

Excellent analytical and problem-solving skills 

Essential

Must possess excellent communication and org