Senior Pharmaceutical Scientist
We are seeking a Senior Pharmaceutical Scientist to work in the Pharmaceutical Development department of a global client of LiCa Scientific’s in South Wales. This role will involve providing technical expertise to drug development, transfer and scale up of projects. You will provide technical expertise over a range of dosage forms, be client focusses and deliver projects to timescales and milestones.
What you’ll do:
You will be leading multiple development, technical transfer and scale-up projects. This will involve acting as Subject Matter Expert for the assigned processes or projects and support all of the companies internal and external needs. This broader heading covers various specific duties as below:
- Responsible for gap analysis (excipient, process, equipment, training) regards New Product Introduction Manufacturing processes
- Responsible for generation of Technical Protocols to allow generation of batch documentation by colleagues
- Review and update of batch records for development, technical transfer, scale-up and validation in accordance with cGMP
- Ensure availability of batch documentation
- Analysis and interpretation of complex data sets
- Generation of Development, Scale Up and Transfer manufacturing reports
- Advise on CAPEX
- CAPA and deviation implementation / investigation
- Customer communication – especially problem solving and continuous involvement activities
- Briefing manufacturing colleagues, promoting best practice (ICH, ISPE)
- Management of direct reports
Degree in suitable scientific discipline (Chemistry, Microbiology, Engineering).
Relevant experience in the above, for this role we require extensive Pharmaceutical Development and Manufacturing process environment, transfer and scale up of manufacturing processes and process validation experience / support.
On this occasion, LiCa Scientific is acting as an employment agency.