Back to search
Job title: Head of Therapeutic Drug Monitoring Unit Laboratory
Location: South Buckinghamshire
Contract: Permanent Full time - 37.5 hours per week Mon to Friday 9am to 5pm
Salary Range: £63,000 to £70,000
Client/Service:
Castlefield Recruitment are partnering with a leading charity based in Buckinghamshire who are seeking a qualified and experienced Clinical Scientist with HCPC registration to head up their Epilepsy Therapeutic Drug Monitoring (TDM) Unit which is the foremost provider of anti-seizure drug monitoring services in the United Kingdom and internationally. The ISO15189 accredited medical service provides personalised medication dosing support for people with epilepsy, enabling better seizure control and improving the lives of people with epilepsy.
Key Responsibilities:
- Responsible for successfully operating the ISO15189 accredited laboratory.
- Ensures that all regulatory and accreditation requirements for the laboratory are met.
- Assists in maintaining and continually improving the high-quality analytical service the Unit provides.
- Ensures that all the requirements of ISO15189:2022 are maintained.
- Implement regulatory-compliant laboratory information management system.
Main Duties:
Service Delivery
- Able to work closely with the TDM Unit's team to maintain stringent analytical criteria and fast sample turnaround times for service users.
- Responsible for daily review, validation, interpretation, authorisation and reporting of results.
- To provide scientific and clinical advisory activities for service users.
- To review and revalidate LCMS assays as required.
- To assist in developing and validating LCMS assays on new equipment and obtain accreditation for developed services.
- To be responsible for preventative maintenance of LCMS and other lab equipment to minimise downtime of instruments.
- To work closely with colleagues and the Directorate.
- Ensure the continued availability of resources for service deliver
Quality, Compliance and Safety
- To work closely with the Quality Manager to ensure the continuous fulfilment of ISO15189:2022 standard requirements.
- To commit to good professional practice, ensure that all lab procedures are fit for intended use and comply with the requirements of ISO15189:2022.
- Ensure that all analyses are undertaken according to written protocols and quality assurance procedures so that the results are of the highest quality and accuracy possible.
- Ensure the fulfilment of Health and Safety regulations in the laboratory.
- Assist in laboratory quality improvements (e.g. resolve audit findings, implement CAPAs, conduct management reviews etc.
People leadership
- To manage the clinical and biomedical scientists’ team and a quality manager, ensuring they perform their duties effectively and in line with international standards and internal policies and procedures.
- To support the personal development of the team to help them perform in their current role and maintain CPD.
- To ensure that the team is integrated with the broader teams, keep them updated with developments and build relationships with colleagues across the organisation.
External Relations
- Assist in co-ordinating and hosting regulatory inspections.
- Provide excellent customer service for internal and external service users.
Other Duties
- To take an active role in risk management, identifying potential risks and challenges in projects and the environment at the TDM Unit and implementing strategies to mitigate these risks.
Skills, experience & qualifications:
Essential
- Registration as a Clinical Scientist with the HCPC
- Experience managing a regulated (ISO15189) clinical laboratory.
- Experience in training and mentoring of junior staff.
- Degree in Pharmacology, Toxicology, Analytical Chemistry, or a related subject
- Master’s degree in medical biochemistry or assessed equivalent of knowledge and expertise in therapeutic drug monitoring.
- Experience in liquid chromatography/mass spectroscopy techniques, assay development and validation
- Experience in laboratory automation
- Experience with laboratory information management systems
- Experience with electronic quality management system
- Working knowledge of COSHH standards and risk assessments
- Fully aware of the regulatory environment and takes the lead in regulatory compliance for TDM in a pragmatic manner.
Desirable
- Experience in business continuity planning, testing and continual improvements.
- Experience in change control management
- Experience in customer relations management
- Experience in leadership and management of various teams (scientific and non-scientific)
- Experience in strategic planning and business development
Employee Benefits
- Holiday entitlement: 27 days holiday + Bank Holidays. Opportunity to buy/sell annual leave and ability.
- Pay date: 25th of every month (or nearest Friday)
- Pension: 4% contribution to group pension scheme with 5% contribution by employee with the option for employees to contribute more
- Death in Service benefit: 2x annual salary
- Employee Assistance Programme: A 24/7 free phone confidential employee assistance programme and helpline available for counselling, financial and legal advice
- Purple Rewards: Access to shopping discounts and cashback with thousands of retailers such as M&S, Boots, Tesco, Superdrug
- Length of Service Awards: Length of service recognition
- Salary Finance: To support you with your money all year round
- Big Y-es: Recognition scheme for those employees who go above and beyond by living our values
- Refer a Friend Scheme: If you refer a friend, who is hired, you receive £250 (conditions apply)
- Car parking: Free on-site parking
- Professional Membership: You may be eligible to claim a professional body annual membership/subscription
- Coffee shop: On-site coffee shop which sells an array of hot and cold meals, snacks, drinks, and refreshments. Ideal for breakfast or lunch
