The Method Validation SME will be a crucial member of the Quality Control team and contribute to the development and performance of Quality Control methods, systems, policies, processes, procedures and controls as they related to the analytical testing of clinical materials.
Responsibilities
- Oversee the qualification, validation, and transfer of analytical methods (e.g., ELISA, quantitative PCR, cell-based assays) from Assay Development to Quality Control for gene therapy product testing.
- Review executed QC test records for product release, including investigation and resolution of deviations, Out of Specification and Out of Trend results, ensuring the appropriate corrective actions are implemented.
- Develop and review validation protocols, test plans, and analytical method reports, ensuring they meet GMP and regulatory standards (FDA, EMA, ICH) and are properly documented.
- Lead the creation and management of sample control processes for GMP release, stability testing, and additional testing needs, ensuring samples are tracked, stored, and processed in accordance with regulatory guidelines.
- Provide hands-on laboratory support, including routine cell culture (adherent and suspension cultures like HEK293, Sf9), and reagent preparation to ensure the timely execution of assays and testing activities.
- Oversee equipment qualification (IQ/OQ/PQ) and manage maintenance, calibration, and troubleshooting activities to ensure that laboratory instruments and equipment are compliant with GMP and perform at optimal standards.
- Work closely with QC management to identify and mitigate risks related to QC milestones and timelines, ensuring smooth progression through validation, testing, and release processes.
- Work cross functionally with various teams to facilitate the timely review and approval of documents, including validation reports, protocols, and test records, ensuring compliance with internal and regulatory requirements.
- Serve as a key point of contact for method validation inquiries, ensuring expertise is shared across teams, while actively participating in cross-functional meetings to drive progress on QC and assay-related initiatives.
Qualifications
- Bachelor's degree in scientific discipline.
- 7-10 years of experience in a GMP environment within the biotechnology or pharmaceutical industry, with expertise in QC testing, assay validation, and method qualification.
- Solid knowledge and understanding of US and international regulations and guidance applicable to Quality Control and method validation.
- Experience in quality control required. A strong background in molecular biology is desired.
- Hands-on experience with analytical techniques such as quantitative PCR, ELISA, and cell-based assays, and proficiency in cell culture (e.g., HEK293, Sf9).
- Experience with assay transfer from R&D to QC and managing assay qualification and validation activities. Familiarity with viral vector products (e.g., AAV) is a plus.
- Strong problem-solving abilities, with experience leading cross-functional teams and driving continuous improvement.
- Excellent interpersonal and communication skills, with the ability to collaborate effectively across teams.
- Flexibility to adapt to changing priorities and deadlines in a fast-paced environment.
Salary
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.