uniQure
Associate Director, QC Analytical Methods
uniQure, Lexington, Massachusetts, United States, 02173
Associate Director, QC Analytical Methods
uniQure is dedicated to bringing innovative therapies to patients. All functions directly or indirectly affect patient lives. This responsibility should be part of our day‑to‑day life by living up to high quality standards and recognizing the sense of urgency in high medical need areas. Overview
The Associate Director, QC Methods plays a pivotal role in the advancement of uniQure’s gene therapy pipeline and will oversee the availability of analytical methods needed for release and stability testing of AAV‑based products throughout program development phases, both in clinical and commercial settings. Key Responsibilities
Oversee selection and availability of analytical methods for cell substrates, starting materials, production process intermediates, purified bulk intermediates and drug product. Identify and maintain relationships with certification testing labs (CLOs) that can provide the necessary testing services; oversee technical transfer and phase‑appropriate validation/verification of analytical methods. Oversee performance of analytical methods, identify potential issues and investigate or replace methods as needed. Qualifications & Skills
Advanced degree (PhD, MSc) in Life Sciences or equivalent experience. 8+ years of analytical and/or quality control experience in a biotech or pharmaceutical industry under GMP environment. Strong experience with analytical methods related to cell & gene therapy products, preferably viral vectors, AAV. Experience with CLOs/CDMOs, outsourcing communication around analytical method panel, performance troubleshooting, technical transfer, validation. Knowledge of QC principles, industry practices, cGMP regulations and guidelines (ICH/FDA/EMA/USP/Ph. Eur.). Excellent written and verbal communication, interpersonal skills, independent work with minimal supervision. Benefits & Logistics
Hybrid position; office located in Lexington, MA; onsite 3 days per week; travel to CLO sites and uniQure Amsterdam site may be required. Waltham, MA • $135,000 – $189,000 (1 week ago)
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uniQure is dedicated to bringing innovative therapies to patients. All functions directly or indirectly affect patient lives. This responsibility should be part of our day‑to‑day life by living up to high quality standards and recognizing the sense of urgency in high medical need areas. Overview
The Associate Director, QC Methods plays a pivotal role in the advancement of uniQure’s gene therapy pipeline and will oversee the availability of analytical methods needed for release and stability testing of AAV‑based products throughout program development phases, both in clinical and commercial settings. Key Responsibilities
Oversee selection and availability of analytical methods for cell substrates, starting materials, production process intermediates, purified bulk intermediates and drug product. Identify and maintain relationships with certification testing labs (CLOs) that can provide the necessary testing services; oversee technical transfer and phase‑appropriate validation/verification of analytical methods. Oversee performance of analytical methods, identify potential issues and investigate or replace methods as needed. Qualifications & Skills
Advanced degree (PhD, MSc) in Life Sciences or equivalent experience. 8+ years of analytical and/or quality control experience in a biotech or pharmaceutical industry under GMP environment. Strong experience with analytical methods related to cell & gene therapy products, preferably viral vectors, AAV. Experience with CLOs/CDMOs, outsourcing communication around analytical method panel, performance troubleshooting, technical transfer, validation. Knowledge of QC principles, industry practices, cGMP regulations and guidelines (ICH/FDA/EMA/USP/Ph. Eur.). Excellent written and verbal communication, interpersonal skills, independent work with minimal supervision. Benefits & Logistics
Hybrid position; office located in Lexington, MA; onsite 3 days per week; travel to CLO sites and uniQure Amsterdam site may be required. Waltham, MA • $135,000 – $189,000 (1 week ago)
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