QC Scientist Analytical Method Validation Expert

3 weeks ago

Lexington, Massachusetts, United States Genezen Full time
Job Summary

The QC Scientist Analytical Method Validation is a key role within our Quality Control Technical Services (QCTS) department at Genezen. This position 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.

Key Responsibilities
  • Optimize, qualify, transfer, and validate analytical methods associated with cGMP production under the guidance of the QC Manager.
  • Write protocols and reports related to QC method transfer, qualification, feasibility, and validation.
  • 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.
  • Train other QC Analysts within the department.
Requirements
  • Adaptability required as work schedule may change based on business needs.
  • Criminal background check required.
  • Other duties as assigned.
Preferred Qualifications
  • BS or MS in Chemistry/Biochemistry or other related Life Sciences.
  • Minimum 6 years of analytical laboratory experience in GLP/cGMP environment ideally associated with analytical method validation and transfer.
  • Prior experience with analytical method validations, analytical data trending/statistical analysis.
  • Understanding of QC instrument qualification is preferred.
  • Thorough understanding of industry testing requirements/standards.
  • Preferred experience with performing cell-based bioassays using mammalian cell-lines (such as HELA, HEK-293, Huh-7, etc.) along with QC instrument qualification is essential.
  • Thorough understanding of industry testing requirements/standards related to gene/cell therapy products.
  • Familiar with ICH, FDA, and EMA guidance documents relevant to gene/cell therapy.
  • Working knowledge of quality systems requirements.
Genezen's Cures Value-Based Competencies
  • Committed to Science: We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
  • Urgency in action for the patients: We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
  • Resilience & Grit in operations: We are committed to overcoming challenges, learning from failures, and persistently striving for success.
  • Execute with Excellence & Integrity: We are dedicated to delivering quality results and upholding ethical principles.
  • Solutions driven for our partners: We are committed to being a proactive, collaborative, creative, and open-minded partner.
Genezen's Benefits
  • Paid vacation days, amount based on tenure.
  • Paid sick time.
  • 9 observed holidays + 1 floating holiday + 1 volunteer day.
  • 401(k) plan with company match up to 6% of salary, vested immediately.
  • 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.

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