Associate Director/Director Analytical Development
Drug Substance, Drug Product and Devices
Zafgen is a biopharmaceutical company leading the way in addressing the unmet need of severely obese patients by bringing ZGN-1061, a first-in-class novel medicine, to market to help patients live longer, better lives. Our purpose as a company is to collaborate with the world’s leading obesity and metabolic disease experts from academic institutions and contract research organizations to apply the best thinking to advance our understanding of the molecular mechanism of our diabetes and obesity treatment program. This thinking is embedded throughout all aspects of our clinical trials, which are designed to evaluate the safety and efficacy of ZGN-1061 in Type 2 Diabetes Mellitus and severely obese patients. We look for talented people to grow our business, advance our science and contribute to our unique culture.
This position will be located in Boston, MA. The person hired for this position provide leadership for Zafgen’s Analytical Development function for Drug Substance, Drug Product and Devices, including:
• Create and implement analytical strategies and phase appropriate procedures in order to build the analytical department.
• Lead method development, implementation, validation and optimization for all stages of small molecule drug substance and drug product candidates.
• Lead overall outsourcing strategy to address analytical needs at external CMO or 3rd party laboratories.
• Lead the drug substance and drug product method development, qualification, validation and transfer of analytical methods for clinical and commercial products to external CMOs and QC laboratories.
• Support the QC stability program for drug substance and drug product development, and review stability data with the CMC team on a periodic basis to report Out of Trend or Out of Specification events.
• Provide input to the development of project strategies, budgets, timelines, and product development plans. Helps ensure that the scientific and business expectations are met.
• Create and/or revise specifications for clinical stage and commercial products.
• Represent analytical function regarding overall CMC strategy as well as content of analytical sections for global CMC submissions.
• Provide support and troubleshooting to Quality Control groups for analytical test methods.
• Establishes systems within the area of responsibility to ensure compliance, good lab practices and work efficiency.
Ideal candidate will have:
• PhD in analytical chemistry or related disciplines with a minimum of 8 years of experience in the pharma/biotech industry in required.
• Proven track record of managing 3rd party CMOs
• Excellent troubleshooting skills in the analytical sciences required.
• cGMP experience and expertise in analytical laboratories is required.
• Experience and expertise in CMC areas of analytical development is required.
• Demonstrated expertise in product specification development is a must
• Action oriented and responsive focus across all levels of the company, as well as with external vendors
• Excellent verbal and written communication skills, detail-oriented personality, and ability to work productively in an interdisciplinary, multi-site team environment
• Ability to travel globally
Zafgen is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Zafgen will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.