Principal Scientist/Team Leader Functional Genomics (Drug Discovery)Role Type: PermanentSalary: DOEWork Area: Drug DiscoveryStart Date: ASAPMy client is a leader in drug discovery and development based...
Microbiology Team Leader
GSK - Harlow
18 month contract
I am looking for an experienced Microbiology team leader to work for a major pharmaceutical company in Harlow. You will lead and manage the microbiology team personnel on a day to day basis, including organization, training, direction and recognition. You will also be responsible for establishing the development of robust and reliable and high-quality drug products.
- Ensure provision of microbiological support for identified projects in development within PD and to manage project-specific interfaces both within PD and with relevant external parties.
- Ensure appropriate Microbiological Quality Control activities are performed including: review and approval of microbiological analytical test results of bulk, intermediate and finished products.
- Ensure successful transfer of microbiological aspects of new drug project submissions including methods and process applications to commercial sites of manufacture.
- Evaluation of microbiological aspects of stability protocols
- Review and approval of microbiological specifications, test methods and other relevant Quality Control procedures
- Ensure appropriate validation of microbiological analytical methods is carried out.
- Responsible for ensuring that microbiological evaluation, method development and reports for products and excipients are carried out within agreed timelines.
- Responsible for ensuring that microbiological monitoring of PD facilities supporting GMP (eg Water systems, gas, air quality and surface monitoring of dispensing, manufacturing and packaging areas) are performed and reported within agreed timelines.
- Responsible for checking, approval and issuing results generated from product manufactures and stability samples, according to agreed deadlines.
- To ensure the microbiological support required, intellectual and practical, for process and product development of sterile and non-sterile products.
- To maintain familiarity with regulatory support required for sterile and non-sterile products.
- Highly experienced in Pharmaceutical Microbiology and related Pharmaceutical activities
- Good knowledge of microbiological standards (industry and regulatory) and laboratory practices
- Demonstrated a track record in Microbiology Reg submissions
- Good knowledge of safe and effective operation of a microbiology laboratory
- Demonstrate effective team leadership and team management skills
- Excellent understanding of the product development process and associated microbiological aspects
- Effective communication to team, peers, management and customers. Presents effectively to internal R&D forums.
- Able to guide daily activities of others and trains others in area of technical expertise
- Very good written and verbal communication skills
To apply for this position, please email a copy of your CV
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.