Senior Scientist Product Development
Jason Johal at CK Science is currently recruiting for a Senior Scientist in Product Development to join a dynamic and ambitious organisation that has committed itself entirely to the research and development of innovative medications across an international stage.
The Senior Scientist will represent Technical Development on product development teams as well as project teams and will actively support and oversee the work of internal teams, external contractors and consultants to achieve company research project and product development goals. Responsibilities will cover all aspects of development related to CMC and product supply for clinical trials and the transition to commercial supply including drug substance, drug product, medical devices, manufacturing processes, analytical methods and characterization and quality control of the products. The role will set, communicate and work within realistic timelines and budgets to meet the overall project goals and ensure technical success. This will be a hands on position and is offered on a full time permanent basis.
Your main responsibilities in this role will be to:
- Support matrix CMC project teams, both internal and with external partners acting as work stream leader and / or subject matter expert on the teams
- Plan, coordinate and supervise work streams within the framework of complex projects or programs, supporting development of budget, timelines and resources, interface planning and project documentation of pharmaceutical development tasks.
- Be practically involved in and/or support the design and development of robust formulations, manufacturing processes and packaging of medicinal products with new chemical entities or existing drug molecules in accordance with industry and global regulatory best practices (eg Quality By Design)
- Be practically involved in and/or support the transfer of pharmaceutical manufacturing processes from lab scale to production scale and process validation
- Oversee and provide project support to method development and optimisation of analytical test methods to evaluate the quality of raw materials, intermediate and final products of drug substance, drug product or medical devices. This includes complex and specialised methods.
- Design, develop and optimise stability studies including complex and special study designs.
- Ensure documentation and data standards fulfil the global requirements to market and distribute the device in any global market (eg CE marking for EU)
- Provide practical and advisory operational support to ensure the in house GMP R&D facilities are maintained and participate in regulatory authority audits and inspections as required.
You are required to have the following qualifications, skills and experience:
- Expert knowledge of Formulations including solid, liquid or parenterals experience
- Demonstrated knowledge and experience of CMC development programmes as a team member or CMC work stream leader
- Specific expert knowledge in an area of pharmaceutics/pharmaceutical development and may have knowledge of pharmaceutical chemistry / analytics and medical devices
- Expertise in and awareness of current pharmaceutics technology, including pre-formulation, formulation and manufacture across a wide range of technologies and platforms including small and / or large molecules
- Awareness regarding clinical supplies requirements and regulations.
- Awareness of various analytical methods used during the development of pharmaceutical products, including, but not limited to, DSC, TGA, HPLC, IR, UV, NMR, Mass Spec
- Understanding of early or late stage development including product stability, product packaging and labeling requirements.
- Awareness of implementing structured experimental designs throughout drug development lifecycle.
- Knowledge of project management tools and processes
- Knowledge and understanding on pharmaceutical laws and regulations (current GMP regulations)
If you are employed by this client you will be joining a company wholly dedicated to the research and development of highly effective and innovative medications and will have the autonomy to make scientific and strategic decisions.
For more information or to apply for this role please contact Jason on +44 (0)1438 723 500 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria. Entitlement to work in the EEA is essential. Please quote reference ST33104 in all correspondence.