Associate Scientist II, Analytical Development

At uniQure our focus is delivering on the promise of gene therapy – single treatments with potentially curative results. We are leveraging our modular and validated technology platform to rapidly advance a pipeline of proprietary gene therapies to treat patients with hemophilia B, Huntington's disease, refractory temporal lobe epilepsy, Fabry disease, and other diseases.

Purpose of the role

The Associate Scientist II, Analytical Development will be part of the Product Analytical Development (PAD) group. The Associate Scientist II, Analytical Development, will be focusing on the execution and reporting of laboratory activities. The core tasks will be focused on hands on laboratory work, data analysis, ordering, and maintenance of laboratory according to best laboratory practices.

Place in the Organization

The Product Analytical Development (PAD) Group is embedded within the Analytical Development department, which besides PAD also consists of the Bio-Analytical Development (BioAD) and the Drug Product Development (DPD) groups. The Associate Scientist II Analytical Development will be a contributor to the activities of PAD group with a specific attention toward the core focuses of the PAD group:

• Developing, qualifying and transfer of product-specific analytical methods to be used for release testing, stability testing, and extended characterization.
• Providing analytical support to DPD and Process Development (PD) activities by ensuring consistent and timely execution of standardized platform product characterization assays, including data review, storage and trending.
• Integrating new program products into uniQure analytical platforms, to ensure timely progress of technology transfers and regulatory submissions.
• Providing late stage analytical development support to Quality and Regulatory efforts, during investigations, risk assessment, regulatory filings and validation activities, to ensure the maintenance and continuous improvement of the analytical packages for each program, in accordance with appropriate legislation and following the highest quality standards.

The Associate Scientist II AD reports to Senior Scientist/Team Lead in Lexington, MA.

Key result areas (major duties, accountabilities and responsibilities) 

• Perform assays according to standard protocols and established procedures to support routine sample testing, assay development, optimization, qualification, and transfer.
• Plan and carry out laboratory work with supervision.
• Ensure all laboratory activities are performed according to applicable protocols, and follow safety and quality procedures to ensure a safe working environment and high data quality
• Document and archive experimental details and assay data in electronic lab notebook system following good documentation practices.
• Notify supervisor of any planned and unplanned deviations in a timely frame.
• Carry out laboratory associated duties, e.g. orders (internal and external), logistic activities, reagent preparation, instrument maintenance, lab cleaning, etc
• Develop and improve new skills and knowledge necessary to successfully support assigned projects.

Qualifications & Skills

• S. or M.Sc. degree in biochemistry, molecular biology, biotechnology or related disciplines is required.
• Hands-on experience in qPCR, HPLC, ELISA, SDS-PAGE, Western Blotting, or other bioanalytical assays is preferred.
• Knowledge of aseptic techniques and hands-on experience with cell culture and manipulation or cell-based assays is preferred.
• Work experience in a regulated setting (GxP), and awareness of GxP pharmaceutical regulations is a plus.
• Basic computer software skills including Microsoft Office is required.
• Fluency in English and good written and verbal communication skills.

Core competencies

• Detail oriented and thorough: Demonstrates ability to carry out tasks with an eye for completeness (e.g. scrutinize results achieved according to acceptance criteria per SOPs and/or protocols).
• Good at planning and organization: able achieve results in a quality and timely way while working on multiple tasks simultaneously.
• Strong sense of accountability and ownership: take responsibilities and be pro-active for the quality and success of the work assigned/performed.
• Collaborative: Shares information and supports other team members. Prioritizes team goals over individual goals. Has good written and spoken communication skills, ability and willingness to work in a high-demanding fast-changing environment.
• Soft Skills: integrity, accurate, organized, dependable, proactive, motivated, flexible.