MSAT Director

uniQure is dedicated to bringing innovative therapies for unmet medical needs to patients. In doing so, each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility is part of our day-to-day working life by (i) living up to high quality standards and (ii) recognizing the sense of urgency in areas of high medical need.

Purpose of the role

This role, within the Technical Operations and Quality organization is pivotal in ensuring seamless communication and operational manufacturing readiness between uniQure Internal functions and uniQure’s CDMO manufacturing partner(s). This position will report to the head of Global CMC Development. The role will require on-site presence at the manufacturing partner, as PIP (Person In Plant) for 50 % or more.

Key result areas (major duties, accountabilities and responsibilities)

• MSAT point of contact between internal teams and CDMO to ensure manufacturing readiness
• Owner of Process Control strategy, including relevant documentation
• Assist PD department in parameter classification and defining NORs and PARs
• Owner of PPQ related documentation (SOPs; protocols; reports)
• Owns production data analysis (with CDMO’s MSAT rep)
• Facilitate planning of manufacturing documentation updates in-line with production schedule and requirements
• Supports PD colleagues to deliver process description document that meet CDMO’s requirements
• When required, consulted for creation of BOM
• Person in Plant (PIP) as needed
• Suggest initiatives on process optimization and implementation of new technologies
• Assist MSAT at CDMO for process deviations
• Manage and coordinate technical reviews of manufacturing deviations, changes or other quality events related to manufacturing activities as required
• Monitor process capability, efficiency and quality
• Ensure MFG process is in valid state throughout the product life cycle
• Generate CPV plans and templates
• Review and approve monitoring, analysis and documenting process data
• Provide or approve continuous improvements

#LI-EB1

• At least 10 years of relevant experience, high preference for a PhD (Biosciences e.g. biotechnology, virology, biochemistry, molecular biology)
• Strong knowledge of manufacturing processes and excellent scientific background in gene therapy
• Relevant experience in the biotechnology or pharma industry within a MSAT, production or process development function
• Experience in experimental study design, statistical data and trend analysis is essential
• Good understanding of GMP, statistical methods, QbD approaches and quality control of data, with excellent attention to detail, communication, presentation, and organizational skills, effective troubleshooting ability, and the ability to work independently and as part of a team
• Working experience with regulatory framework regarding ATMPs (EP, USP, ICH, EMA/FDA guidelines)
• Fluent in English

• Sound scientific and technical proficiency
• Trouble shooter, problem solver mentality
• Excellent communicator
• Effective collaborator able to build strong relationships with both internal and external stakeholders
• Action oriented
• Ability to operate in a fast-paced, multi-disciplinary environment
• Strong Leadership skills
• Autonomous thinker with a sense of urgency
• Leader / team player with an attitude to mentor others
• Ability to travel – most if not all of uniQure’s CDMOs are in US