Lead Microbiologist

**Site Name**: UK - Hertfordshire - Ware

**Posted Date**: Apr 29 2024

The Quality Assurance Department at the GSK Ware Pharma Supply Chain site is responsible for ensuring that all aspects of the manufacture of products is performed in a controlled manner and meets commitments to international regulatory bodies, as well as the requirements of current Good Manufacturing Practice.

The Microbiology Laboratory team works as part of the Site Value Streams to ensure that manufactured products are compliant and fit for purpose. This includes product analysis, laboratory investigations, and trend analysis of microbiological results.

**Job Purpose**:
The purpose of the role is to perform analysis/collection of samples and support process or environmental monitoring (using a range of microbial/chemical techniques). The Lead Microbiologist is skilled / proficient in Microbiological techniques (set up and use). You will support the Laboratory Team Manager by providing expert laboratory analytical services for the site to ensure delivery of compliant products to our customers. This includes trouble-shoot and identify remedial actions in line with procedure and working on specific initiatives aligned to Laboratory strategy. You will work to assist the Laboratory Team Manager in overseeing the execution of batch/job testing and release (for testing groups), as well as providing guidance and support to the wider Microbiology team.

**Key Responsibilities**:

- Prepare and check data accurately according to company, customer and regulatory requirements.
- Verify the quality and accuracy of results for material to meet pre-defined acceptance criteria.
- Take a lead role in the batch/job approval process.
- Responsible for assigned items of Laboratory equipment and instrumentation or 5S standards (as an expert user, resolving issues and promoting best practice).
- Take a lead role in provision of training for New Starters, and for Microbiologists in areas of expertise.
- Responsible for the safety of self and others within the Laboratory.
- Carry out testing using appropriate aseptic techniques.

**About You**:
This role would suit a motivated person who has strong experience of working in a GMP (Quality) environment. Strong people skills and a proven ability to work in a team (eg; flexible approach, good communication, planning and organizational skills) as well as good report writing skills. You should have knowledge/experience of microbiology laboratory testing techniques, ideally within a GMP environment (including knowledge of the microbiological requirements for non
- sterile pharmaceutical manufacture). An excellent understanding and appreciation of the testing of raw materials and final product, as well as environmental and water testing is important. You will also have a strong continuous improvement mindset and a willingness to work towards standardised and lean working practices.

**About Ware Manufacturing Site**:
Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form. The site holds a unique position in our network as the only site responsible for launching the company’s pipeline of new medicines in these dose forms.

**Basic Qualifications**:

- Relevant qualifications and / or experience (laboratory / microbiological testing and experience of managing and planning day to day activities for a team)
- Good understanding of key microbiological methodologies

**Preferred Qualifications**:

- Ability to perform microbial identification utilising Gram staining, biochemical techniques and full speciation using MALDI-TOF
- Knowledge of current Good Manufacturing Practice (cGMP) and understanding of its impact on own role (and the implications of not following cGMP)
- Knowledgeable in the use of laboratory software, such as Sapphire/ LIFT and M-ERP

**Benefits**:
GSK offers a range of benefits to its employees, which include, but are not limited to:

- Competitive base Salary
- Shift allowance and contractual overtime
- Annual bonus based on company performance
- Opportunities to partake in on-the-job training courses
- Opportunities for support for professional development and chartership (accreditations and professional bodies)
- Access to healthcare and wellbeing programmes
- Employee recognition programmes

If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | GSK.

**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform