Formulation Scientist

SUMMARY:

- Vaccine Research seeks to discover novel vaccines (prophylactic and therapeutic) for the prevention and treatment of significant human diseases using a variety of vaccine technology platforms combined with immune-modulatory agents.
- An individual with biological formulation and characterization experience is required to join the Vaccine Research West group to run a variety of assays to support vaccine candidate evaluation.
- Large stability studies involving numerous viral targets, various formulations and using specific biological characterization endpoints are required to progress a particular project forward.
- The candidate will have strong knowledge and practical experience in the application of stability studies and characterization techniques to the selection of promising formulation candidates.
- Stability studies will focus on viral targets, with typical biological (protein) biophysical characterization tools being applied.
- This will involve numerous colleagues across different lines, thus communication and the ability to interact well with others is key.
- A clear and organized thought process, with an attention to detail and a high quality work ethic are essential.
- Experience in buffer manufacture, buffer exchange methodologies (dialysis, desalt columns and UF/DF) and working within Class II environments is also highly beneficial.
- Experience in biophysical techniques, such as DLS, BCA, CD, intrinsic fluorescence, SEC, SEC-MALS et al, as applied to protein and/or viral vectors is required. The use of these in a high-throughput format and in the context of a stability studies is preferred. In addition, ensuring the execution of these characterization tools to reduce and control inter-day variability within a stability study is essential.
- Candidates must be independent and able to proactively apply their knowledge in the design, execution and qualification of analytical methodologies, to enable progression of vaccines projects and hand over to pharmaceutical science partners.
- Experience of viral lyophilization may also be beneficial.
- An understanding of the regulatory environment, particularly ICH, FDA and EMA guidelines on stability guidelines would also be advantageous.
- The candidate will be required to work under minimal supervision and as a member of a project team, be accountable for the critical appraisal of their results and regularly present them for review at team meetings and for specific project milestones.
- The role is laboratory based, with support as needed in areas requiring further development.
- RESPONSIBILITIES:
- Laboratory and related work (80% of time) under supervision of project leader -
- Experimental design of stability studies for selection of viral formulations to enter clinical testing.
- Experimental design based on literature review and discussion with peers or supervisor as required.
- Interaction and organization with other parties required for successful execution of stability studies, such like analytical and in vivo colleagues.
- Execute a series of experimental tasks to address specific scientific objectives of the project (with guidance in areas of significant novelty).
- Analysis of data generated (your own and by others) to identify issues and implement necessary changes.
- Analysis and critically interpret experimental data, results and methodology used.
- Will have and maintain skills and experience to be fully conversant with the operation and validation of all items of equipment or IT needed for experimentation, data analysis, storage and data entry.
- Will regularly use the scientific literature and electronic information critically to enhance understanding of disease/technology area and generate novel methods and testable hypotheses
- Documentation.
- Authorship of SOPs, study reports and protocols.
- Write-up laboratory notebooks regularly in compliance with IP policy and GSP
- Preparation of presentation materials.

SKILLS:

QUALIFICATIONS:

- BSc in a relevant science, preferably in analytical chemistry, protein biochemistry or pharmaceutical sciences.
- At least 3 years working in a laboratory in an industrial setting, with a primary focus on the formulation and characterization of proteins or other biologics using standard methods.
- Demonstrable evidence of ability to troubleshoot, propose alternatives and critically review analytical data trends.
- Ability to work from first principles (literature review, internal development documents etc) to establish analytical methods and techniques.

PREFERRED:

- Proven expertise with a range of physicochemical methodologies consistent with ICH guidelines for quantifying purity/quality of proteins, peptides, VLPs and viral vectors.
- Experience in characterization of formulated vaccine drug products.
- Design and executing assays in accordance with industry best practice for quantifying components of formulated vaccines.
- Compiling and analysing data which is routinely presented to project teams to enable decision making.
- Transfer of validated methodologies to partner lines consistent with project timelines and regulatory expectations.
- Experience in analysis of higher-order structure in proteins, especially in the context of lyophilized products.