Senior Scientist Downstream Process Development
- Experience Level
- Senior Management
Hobson Prior are recruiting for a Senior Scientist Downstream Process Development to join a biotech organisation, focusing on improving health all over the world through discovering and developing vaccines to prevent serious diseases. This is a permanent position, located in Gaithersburg Maryland.
- You will generate, manage, evaluate, and maintain critical data in a highly orderly manner. Deliver reports for assessment by senior management.
- To take lead in the assessment of a new purification process, by reviewing and compiling relevant literature data to include structure, physico-chemical, and biological data on the target protein, to propose the most suitable purification process train of steps based on these data.
- To have ability to process complex data and communicate clearly and timely the implications of the results.
- You will perform and analyse Design of Experiment studies to develop or optimizing processes to ensure a phase-appropriate, consistent, high-yielding, high-purity, and scalable downstream purification.
- To assist in scale up and optimization of early stage processes, support critical operations as needed in our GMP manufacturing facility and deliver materials for pre-clinical and clinical studies.
- To provide substances and other supplies for various projects and departments.
- To collaborate and coordinate with colleagues from Discovery, Process Development, Analytical Development, Manufacturing, and QA/QC teams.
- You will support process characterization studies and tech transfer process. As needed, support process validation, including validation protocol writing, execution and report writing.
- Enhance the proposed process to demonstrate it is strong, economic and scalable for clinical stage manufacturing of nanoparticle vaccine and other biologic product candidates, with particular attention to regulatory expectations on product quality and also on suitability and sourcing of raw materials, reagents, and separation materials. Ensure unit operations are possible to implement at the intended manufacturing scale.
- You will design experimental work self-sufficiently or with minimal supervision.
- Be accountable for integrating robust viral clearance steps into the process and working closely with the Viral Clearance Validation team, including review of protocols, execution of studies, and report writing.
- This position is expected to be mainly hands on in the laboratory.
- Excellent at performing numerous functions in a fast-paced environment. Have strong technical protocol/report writing, and good organization skills.
- Excellent record keeping abilities to adequately record, analyse and document data generated in support of regulatory requirements.
- Have previously demonstrated verbal and written skills in communicating scientific and technical information.
- Requires PhD in relevant field or a minimum of 10 years relevant experience with a master's degree.
- Solid and hands-on downstream purification experience is required. Multi-year industrial purification experience with vaccines/biologics is preferred; direct experience with virus-derived recombinant products and/or viral particles is a plus.
- Have various knowledge and experience in relevant areas, including but not limited to molecular/cell biology, harvest, formulation and common analytical tools is preferred.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.