Principle Production Scientist
Proclinical are seeking a bright, enthusiastic and motivated Principle Production Scientist with an understanding of immunology to join a pharmaceutical company. This is an excellent opportunity to join well-funded, exciting new start-up in London.
- Lead the scientific aspects of clinical studies
- Perform problem-solving of closed system cell culture production processes by identifying and implementing procedures in accordance with GMP and relevant regulatory standards and in accordance with Quality Systems.
- Develop and implement improvements or changes to production methods, techniques, processes and equipment in order to advance the process optimisation progress.
- Lead preparation of GMP compliant documentation for the GMP Facility including, but not limited to IMPD, PSF, BMR, SOP, Change Control, COSHH assessments and Risk assessments.
- Ensure operational excellence and to exercise good housekeeping.
- Ensure all manufacturing activities are undertaken in accordance with the production requirements and to current GMP regulatory and quality standards.
- Oversee performance of in process control and final release analytical assays, analyse and interpret the results.
- Master high standards in production documentation ensuring that all procedures are documented and reviewed to appropriate quality standard
- Responsible for reporting of any deviations occurring during the manufacturing process and ensure a deviation report is submitted and corrective and preventative actions progressed to completion.
Skills and Requirements
- PhD in a Biological Science discipline.
- 15 years' experience in a scientific laboratory role.
- 5 years' experience working in a regulated environment (GLP/GCLP/GMP).
- Experience in human cell culture (patient blood and tissue) in R&D as well as GMP compliant environment.
- Have good communication and interpersonal skills.
- Self-motivated with strong initiative and drive.
If you are having difficulty in applying or if you have any questions, please contact Dominic Cappell at firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.