Sr Manufacturing Technician

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

The department Manufacturing has an important role regarding the quantity and quality of our AAV-based products. cGMP is applied to manufacture and verify the quality of our products to ensure (i) proper delivery and functionality as well as (ii) safety. Those activities are supporting the whole scope of AAV product and process development. By strict application of cGMP guidelines, monitoring and qualification of our manufacturing environment and systems, the manufacturing of drug substance and drug product is performed.

Manufacturing performs all required process steps and in process controls, in close collaboration with Process Development, QC and QA.

Key result areas (major duties, accountabilities and responsibilities)

• Independently perform manufacturing of uniQure’s therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements
• Experiences with Down Stream Processing (column packing / purification and/or UF/DF)
• Review of performed process steps of co-workers
• Contributes to keeping the GMP documents up to date and thinks about ways and means of improvements
• Keep the manufacturing plant, labs and activities up-to-date in order to meet uniQure’s needs in terms of planning, quality, safety, health and environment
• Participate in troubleshooting and document Quality Indicator investigations
• Interact with the Quality Control department for the planning of analytical samples and monitoring activities

Qualifications

• A college degree / courses in chemistry or biology preferred or equivalent experience
• Preferably working experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization
• Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes and procedures
• Hands-on experience in writing and reviewing documentation
• Experience in (bio)-manufacturing unit operations (USP and/or DSP)
• Good writing and oral communication skills
• Applies experience and skills to complete assigned work within own area of expertise
• Works within standard operating procedures and/or scientific methods

Core competencies

• Process-oriented way of thinking and working
• Detail oriented
• Self-organized
• Able to communicate in professional way on diverse levels and channels
• Capable of taking initiative when necessary
• Flexible attitude in a challenging environment
• Intrinsically motivated