Sr. Scientist/Scientist II-III, QC Critical Reagents

Genezen•Lexington, MA

1d•$100,000 - $145,000

About The Position

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 T h e Sr. Scientist/Scientist II-II, Critical Reagents i s respo n s i b le 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 p ipeline and commercial product s. This position requires strong leadership skills , sta tistical and technical knowledge, and a commitment to quality and compliance. The position will be hired at the Scientist II, Scientist III or Sr. Scientist level based upon the experience of the successful candidate.

Requirements

BS or MS in Life Sciences or Engineering Essential
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 . Essential
Expertise in reference standards programs, including ICH regulations and quality control methods. Essential
Proficiency in writing SOPs, qualifications protocols, and reports. Essential
Famil iarity with statistical software (JMP) . Essential
Excellent analytical and problem-solving skills Essential
Must possess excellent communication and organizational skills Essential
Cross functional collaboration ability to work well with diverse groups Essential
Ability to manage multiple activities with challenging timelines Essential
Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint ) Essential
Effective oral and written communication skills Essential
Confident, independent, self-starter, proactive, and results-oriented with high performance and compliance standards Essential
Exhibits highest integrity and committed to ethics and compliance standards Essential
Open and transparent in sharing data and information Essential

Nice To Haves

Strong background in biostatistics for evaluation comparability and qualification of new reference standards and control reagents. Desired
Experience in Qu ality Control within the biological pharmaceutical industry. Desired

Responsibilities

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