QC Scientist Analytical Method Validation

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 Analytical Method Validation is key role within our Quality Control Technical Services (QCTS) department. The individual in this role will work collaboratively with the analytical development team, quality control, and quality assurance to transfer and validate next generation analytical procedures for the testing of viral vectors, cell banks and gene therapy products in support of Genezen’s services and commercial products in compliance with company policies and procedures and regulatory guidelines.

ESSENTIAL JOB FUNCTIONS

• Works under guidance of QC Manger responsible for optimization, qualification, transfer and validation of analytical methods associated with cGMP production
• Writes protocols and reports related to QC Method transfer, qualification, feasibility and validation
• May assist in writing protocols or participate in instrument qualifications
• Perform statistical analyses of data generated during method validation studies, qualification and critical material qualification
• Support monitoring of analytical method performance, including assessment
• of analytical method system suitability requirements
• Assist with data trending and aid in compilation of trend reports
• Support cGMP operations, including generation of documentation in support of change controls and corrective actions/preventative actions, deviations, out-of-specification (OOS) results, and other investigations or assay troubleshooting
• Present to cross-functional teams and effectively communicate critical analytical issues and solutions
• Subject matter expertise in product quality attribute methods relevant to gene therapeutic product (e.g. cell function characterization assays, HPLC, PCR / qPCR, ELISA, Potency Assay, SDS-PAGE and western blot) and/or viral vector manufacturing
• Familiar with FDA and EMA guidance documents relevant to gene therapy
• Working knowledge of quality systems requirements
• Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities
• Demonstrated leadership skills and the ability to collaborate with and effectively influence others
• Establish, revise, review and maintain procedures (including protocol and technical report)
• Assure that laboratory procedures are current and facilitate updates as required
• As applicable perform routine/non-routine testing of in-process, final product in accordance with Standard Operating Procedures (e.g., Q-PCR, Potency Assay, Western Blot, Refractometry, ELISA, etc.) as needed
• Complete documentation in accordance with current Good Manufacturing Practices (cGMP)
• Maintain QC lab and related systems to ensure compliance with industry standards
• Identify, lead, and/or support continuous improvements to current processes/procedures accordingly for increased compliance and efficiency
• Troubleshoot equipment and analytical testing methods
• Training of other QC Analysts within the department

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 Chemistry/Biochemistry or other related Life Sciences

Essential

ON-THE-JOB EXPERIENCE

 

Minimum 6 years of analytical laboratory experience in GLP/cGMP environment ideally associated with analytical method validation and transfer.

Essential

Prior experience with analytical method validations, analytical data trending/statistical analysis

Essential

Understanding of QC instrument qualification is preferred.

Desired

Thoro