Remote

Contract, Analytical Science & Technology - Gene Therapy

PTC Therapeutics, Inc
United States
Feb 20, 2025
Job Description Summary: The Contract, Analytical Sciences & Technology (AS&T)- Gene Therapy is responsible for managing change controls, deviations, investigations within the Quality Management System (QMS) in support of method transfers; method improvement; method remediation and method validation/verification and/or troubleshooting for commercial products. She/he manages oversight of analytical data and data analysis for routine release and stability testing and for post-marketing commitments for clinical and commercial products. The Contract, AS&T- Gene Therapy is also responsible for assisting with investigating commercial product complaints/issues at all manufacturing sites, internal and external. She/he works cross-functionally in a matrix management environment that includes, but may not be limited to, Analytical Development (AD), Process Development (PD), Clinical and Commercial Manufacturing, Quality Assurance (QA), Quality Control (QC), Regulatory Affairs, Supply Chain, and Discovery Research. The Contract, AS&T- Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. Job Description: KNOWLEDGE/SKILLS/ABILITIES REQUIRED * Minimum level of education and years of relevant work experience. Master's in molecular biology, virology, biochemistry, or related field and a minimum of 5 years of relevant and progressively responsible experience in these same areas. * Special knowledge or skills needed and/or licenses or certificates required. Knowledge of the analytical methods used for gene therapy or biologics in-process testing, release testing and characterization, with an emphasis on potency assays. Proven experience with change controls, deviations/investigation within a Quality Management System Strong knowledge of CMC analytical and regulatory requirements. Demonstrated and applied experience in laboratory operations, including development and adherence to quality metric programs Applied knowledge of cGMP requirements as they pertain to analytical development and quality control testing. Knowledge of cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE, and molecular biology techniques. Experience overseeing clinical or commercial release testing within CROs/CMOs. Team oriented and able to manage assigned project responsibilities across various development stages. Hands-on experience writing/reviewing SOPs and/or analytical methods in support of quality systems. Proficiency with Microsoft Office Excellent oral and written communication skills. Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members. Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Excellent planning, organization and time-management skills including the ability to support and prioritize multiple projects. * Special knowledge or skills needed and/or licenses or certificates required. Small company and/or start-up experience. Proficiency with JMP Ability to present and interact in cross-functional teams. Experience in managing statement of work (SOW), purchase orders (PO) and material inventory with external partners. Certification in CMC technical writing. Travel requirements N/A Office/Remote-based position EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination. Click here to return to the careers page