The Associate Scientist III Analytical Development will be part of the Product Analytical Development (PAD) group. The Associate Scientist III Analytical Development will focus on the execution and reporting of laboratory activities. The core tasks will be focused on planning and performance of laboratory work, data analysis, results trending and reporting, SOP/Documentation writing, and assay transfer activities.
Place in the Organization
The Associate Scientist III, Analytical Development will be part of the Product Analytical Development (PAD)
group supporting the late-stage
development of AAV-based gene therapy products. The Associate Scientist III Analytical Development will
focus on the execution and reporting of laboratory activities. The core tasks
will be focused on planning and execution of laboratory work, data analysis,
results trending and reporting, SOP/Documentation writing, and assay problem
solving activities. There will be a
significant amount of cross-functional communication activities as well.
The Product Analytical Development (PAD) Group is embedded within the Analytical Development department, which also consists of Drug Product Development (DPD). The Associate Scientist III Analytical Development will be a contributor to the activities of PAD group with a specific attention toward the critical activities of the PAD group:
- 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
- Developing, qualifying and transfer of product-specific assays to be used for release testing, stability testing, and extended characterization.
- Providing analytical support to 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 transfer and regulatory submissions.
The Associate Scientist III AD reports to the AD Senior Scientist /Team Leader.
Key result areas (major duties, accountabilities, and responsibilities)
- Perform assays following standard protocols and established procedures to support routine sample testing, assay development, optimization, qualification, and transfer.
- Independently plan laboratory work and interpret results and evaluate next steps in experimental design, including rationale supporting suggested path forward.
- Participate in troubleshooting and new technology evaluation/adoption, including method variations to aid in troubleshooting or optimization efforts.
- Document and archive experimental details and data in electronic system following good documentation practices with minimal supervision.
- Carry out laboratory associated duties e.g. orders (internal and external), logistic activities, reagent preparation, instrument maintenance, lab cleaning, etc
- Train Associate Scientists and co-op interns and assist them with their planning and coordination of daily activities.
- Communicate & coordinate with other internal teams to ensure alignment on timelines & deliverables associated with assigned projects
- Summarize and present data in a coherent manner within the AD group and to cross-functional teams.
- Acquire new skills and knowledge as needed to successfully support assigned tasks and projects
- Participate in AD process improvements and implementation when necessary
Qualifications & Skills
- Minimum of M.S. degree with 2+ years or B.S. degree with 4+ years’ relevant experience in biochemistry, molecular biology, analytical chemistry, or related disciplines is required.
- Knowledge of aseptic procedures and hands-on experience with cell culturing and manipulation, and cell-based assays (e.g. insect and human cells)
- Knowledge and hands-on experience in qPCR, HPLC, ELISA, SDS-PAGE, Western Blotting, or other bioanalytical assays.
- Experience in assay development and trouble shooting.
- Strong technical documentation skills (SOP, Protocols, Reports)
- Awareness of GxP pharmaceutical regulations or work experience in a GxP setting is a plus
- Experience in viral vaccines or gene therapy is a plus
- Computer software skills including Microsoft Office
- Strong interpersonal and communication skills in English, written and verbal including presentation of technically complex data
- Detail oriented: Demonstrates ability to carry out tasks with an eye for completeness (e.g. scrutinize results achieved according to agreed SOPs and/or protocols).
- Excellent planning and organizing skills: Able to set priorities, manage time, and plan own workload to achieve timely results while ensuring the highest standard of quality. Communicate with others to align planning and manage multiple complex activities simultaneously. Coordination of planning and scheduling activities for more junior team members
- Strong sense of accountability and ownership: take responsibility for and actively ensure the quality and success of the work assigned/performed.
- Capable of analytical thinking and problem solving: Able to recognize problems and identify solutions. Able to recognize and separate the key components of problems and situations, generate suitable solutions, evaluate possible solutions, and choose the most appropriate option.
- Strong written and spoken communication skills: including document writing and oral presentations. Able to critically analyze and present complex data sets in a clear and organized manner.
- Collaborative: Shares information and supports other team members. Prioritizes team goals over individual goals. Shows willingness to work in a high-demanding fast-changing environment.
- Soft Skills: accurate, organized, dependable, proactive, motivated, flexible