We are recruiting for a Senior Pharmaceutical Scientist to join a client in South Wales on a permanent basis.
Salary to£40,000 (depending on experience)
Our client is a pharmaceutical manufacturer with facilities for highly potent compounds, specialising in niche pharmaceutical therapies. The company offers a range of out-sourced pharmaceutical services and can support clients from early stages in development to clinical trials through to commercial supply. Due to continued expansion they are looking to recruit an additional Development Team Leader for their analytical development services department.
What you’ll do:
The main purpose of the Senior Pharmaceutical Scientist role is to lead a team of scientists and manage multiple complex pharmaceutical development, transfer and scale up processes. You’ll provide technical expertise for this over a range of dosage forms and be client focussed, delivering projects to agreed timelines.
Key responsibilities for the Senior Pharmaceutical Scientist:
- Lead multiple complex pharmaceutical development, technical transfer and scale up projects.
- Able to act as SME for assigned process/projects to support all internal and external needs, including client visits and regulatory audits.
- Responsible for generation of various gap analysis e.g. excipient, process, equipment, training to support efficient and effective on-boarding of NPI manufacturing process.
- Responsible for the generation of technical protocols to allow generation of required batch documentation by Associate Process Scientist. Generation of DOE protocols to support development activities
- Responsible for the reviewing and generation of manufacturing batch records for development, technical transfer, scale up and validation in accordance with cGMP practices.
- Responsible for the analysis and interpretation of complex data sets e.g. DOE results using statistical tools including JMP, Minitab and Design Expert.
- Responsible for the generation of Development, Transfer and Scale up manufacturing reports within agreed SLA to support achievement of project milestones.
- Ensure up to date engineering solutions and technologies are employed when working on new projects
- Advise and support CAPEX and/or improvement activities in the manufacturing area required to support client projects.
- Lead Complex deviation investigations using RCA tools to determine Root cause and support CAPA implementation.
- Liaise with all functions to ensure that production schedules are adhered to 100% of the time where this is possible.
- To communicate effectively with internal and external customers and participate with them in problem solving and continuous improvement activities
As an experienced Senior Pharmaceutical Scientist the essential requirements are:
- Degree in scientific subject (Chemistry or Microbiology)
- Higher Degree in a suitable scientific discipline (e.g. chemistry, pharmacy, microbiology, engineering) or equivalent experience.
- Knowledge of Potent molecules and other dosage forms Technical transfer and
scale up of manufacturing process, including process validation.
- Knowledge of EMEA/FDA and Japanese markets
- Experience of leading and development of small team of technical specialists
- Extensive experience in Pharmaceutical development and manufacturing
- processing environment, ideally in OSD/Liquids
- cGMP knowledge and experience
On this occasion LiCa Scientific is acting as an employment agency.
Do email email@example.com with any questions or your application.