QC Scientist Analytical Method Validation - Genezen

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

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 25 pounds
• Occasionally lift and/or move up to 50 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus
  Communication
• Frequently required to communicate by talking, hearing, using telephone and e-mail