The Analytical Support Supervisor will be part of the Product Analytical Development (PAD) group. The Analytical Support Supervisor will focus on planning, execution and reporting of laboratory activities. The core tasks will be focused on planning, designing, executing and reporting experimental work, data analysis trending, and reporting, SOP/Documentation writing.
Place in the Organization
The PAD Group is embedded within the Analytical Development department, which also consists of Bio-Analytical Development (BioAD), and Drug Product Development (DPD). The Analytical Support Supervisor will be a contributor to the activities of PAD group with a specific attention toward the critical activities of the PAD group:
- Developing, qualifying and transfer of product-specific assays to be used for release testing, stability testing, and extended characterization.
- Providing analytical support to DPD and PD (Process Development) 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 transfer and regulatory filing efforts.
The Analytical Support Supervisor reports to the Analytical Development Senior Scientist /Team Lead.
Key result areas (major duties, accountabilities and responsibilities)
- Independently plan own and team laboratory work to ensure maximum efficiency while ensuring alignment with overarching deliverables and laboratory resource utilization (e.g. use of lab equipment)
- Coordinate planning, scheduling activities of technicians within the team communication and alignment with internal stakeholders.
- Executes experiments and prepare data overviews and reports, including interpretation of results. Suggest next steps in experimental design including rationale for suggestions
- Drafts and reviews laboratory and technical documentation relevant to assay execution (Electronic Lab Notes, SOPs), assay development, qualification, transfer, troubleshooting or other PAD relevant studies (protocols, reports, position papers and memos)
- Collect, and store experimental data sets and document analytical results to ensure maximum traceability
- Prepare data overviews and reports, including interpretation of results. Suggest next steps in experimental design including rationale for suggestions
- Ensure training of technicians on relevant analytical methods and laboratory and data recording practice
- 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
- Notify superior of all observed deviations in a timely frame and provide input on the possible cause of the deviation and proposed remediation plan.
- Improvement of skills and knowledge necessary to successfully support assigned tasks and projects through training and independently. Continuously improve and update her/his area of expertise.
- Provide improvement suggestions and support the improvement implementation.