Your new role
As a (Senior) Scientist PAD you will be part of the Product Analytical Development (PAD) group. You will focus on defining and managing the execution of the analytical development strategies and activities across the product lifecycle through in depth understanding of the product properties and TPP (Target Product Profile), aligned with AD function and CMC team. You own the analytical development lifecycle both from a technical and planning stand point. Responsibilities will include scientific review and oversight of assay design, development, qualification, troubleshooting, and transfer as well as product characterization. You will also be responsible for ensuring oversight the analytical project timelines, and alignment across different members contributors to the analytical development efforts. You will report to the Analytical Development Team Lead.

Your responsibilities include:

• Owning the development lifecycle (Assay development, qualification, transfer), planning and timelines for multiple projects

• Responsible for analytical strategy and timeline definition and monitoring in line with overall project timelines and functional team input.
• Overseeing the project from an analytical standpoint as core member of the project (CMC) team, and has key interactions with drug product development, drug substance development, supply chain, quality assurance, regulatory affairs and external consultants and vendors
• Communicating and aligning with internal and external stakeholders activities relevant to specific projects planning and progression.
• Coordinating activities to be executed by the team and with help of other teams. Defining experimental plans underlining development, qualification, transfer and troubleshooting relevant to CMC activities or regulatory filing (e.g. extended characterization, early ref materials, etc.)
• Preparing data overviews and reports, including interpretation of results. Proposing next steps in experimental design including rationale and timelines.
• Drafting or reviewing laboratory and technical documentation such as SOPs, protocols, reports, position papers and memos
• Assisting team members with their planning and coordination of activities
• Ensuring all laboratory activities are performed according to applicable procedures to ensure a safe working environment and high data quality
• Providing improvement suggestions and enforce improvement implementation

Your profile
To be successful as a (Senior) Scientist PAD you need to have a PhD with at least 3 years of industrial experience in a Life Sciences-related field (biochemistry, molecular biology, biotechnology). You combine this with very good knowledge of biostatistics and development of bioassays and specifically potency assays under FDA and ICH guidelines.
You also have broad knowledge of the pharmaceutical industry, including in depth operating knowledge of functions involved in analytical within drug development processes. Because it’s such a senior role, you need to have project management skills and leadership experience, including setting timelines, alignment and helping others to meet timelines.

Additional requirements include:

• Extended firsthand experience in technical documentation writing and reviewing (SOP, protocols, reports, IND/IMPD/BLA sections), and good understanding of pharmaceutical regulations
• Thorough scientific knowledge and hands on experience with cell based assays and bioassays
• Thorough scientific knowledge and hands on experience with relevant molecular biology techniques (e.g. (q)PCR, DNA electrophoresis)
• Thorough scientific knowledge and hands on experience with biochemical analyses (e.g. protein electrophoresis, western blotting, ELISA)
• Thorough scientific knowledge in the process of assay design, assay development and trouble shooting
• Thorough scientific knowledge product characterization and forced degradation studies
• Experience in viral vaccines or gene therapy

About the organization
Your new company is based in the Amsterdam area and focuses on making the future of medicine better using gene therapy. By doing so, they help patients with serious unfulfilled medical needs. This means that you will, indirectly, contribute to helping those patients and potentially giving them a better life. On a daily basis you will contribute to this as well. The company is continuously looking for highly motivated and skilled people who are willing to make a difference.

The benefits
You will work in an international and dynamic environment with many opportunities to grow your career for the long term. The salary depends on your education and experience and they offer great secondary benefits, such as 30 holidays, travel expenses, stock options, a good pension scheme, a monthly allowance for your health insurance, an annual personal education budget and a company fitness plan. It’s an amazing environment, will you join them as a (Senior) Scientist PAD?

What you need to do now
Are you interested in this vacancy as (Senior) Scientist PAD ? Click on 'Apply' and send an up-to-date CV or call Merel Hasselo on +31620076590. If this vacancy is not exactly what you are looking for, but you are looking for a different position, please contact us for a confidential discussion about your career options. #1045760