Envigo RMS, Inc. Team Leader - Chemistry, Manufacturing & Control in Huntingdon, United Kingdom
At Envigo, we are working together to build a healthier and safer world, we exist to help our customers secure the potential of their research and develop products that enhance and enrich life.
It’s an exciting time to join the expanding Chemistry, Manufacturing & Control (CMC) Department our site in Alconbury, Cambridgeshire.
The new position of Team Leader within this Shared Resource team is responsible for leading a team of analysts and technicians which performs equipment qualification, sample logistic and general housekeeping activities. The Team Leader provides direction and leadership through management of their allocated resources, ensuring all equipment maintenance and qualification activities are performed according to defined schedules, all sample logistics activities are performed in a manner that facilitates the operational department’s production results/reports within time frames agreed with clients, and ensures all general house keeping is conducted according to agreed schedules. They maximise capacity and productivity by managing their resources to achieve optimum use of staff, equipment and facilities while maintaining a focus on maintaining the highest possible levels of quality.
As a Team Leader at Envigo your main responsibilities will be:
- Keeping abreast of regulatory guidelines and industry expectations and contribute to the establishment and delivery of appropriate services and maintaining GMP/GLP regulatory compliance of procedures and ensuring that all work/data is of a high quality.
- Providing expert advice on equipment qualification and sample logistic processes to colleagues and clients, maintaining awareness of current trends, issues and developments.
- Lead activities in relation to the implementation of new equipment, IT systems and procedures / processes.
- Managing allocated resources to achieve optimum use of staff, equipment and facilities, thereby maximising capacity/productivity and ensuring that all targets and deadlines are achieved.
- Reviewing performance and development of direct reports.
- Developing and maintaining a training programme to meet client requirements and realise individual potential.
- Supervising and providing hands-on training of personnel in accordance with current regulatory (GxP) requirements and client requirements.
- Continually seeking to identify opportunities for, and lead improvements in quality and productivity.
- Taking a lead role in problem resolution and provide advice to colleagues in solving equipment qualification issues.
- Manage all GMP change control, deviations and CAPA activities that are required in relation to equipment qualification and sample logistic activities.
- Contributing to the overall management of the department
The skills and experience we’re looking for are:
- Graduate (B.Sc.) and relevant industry experience.
- Experience of working in a regulatory environment, ideally GMP.
- Demonstrated expertise in managing people effectively.
- Excellent communication and customer service skills.
- Scientific experience in area of expertise.
- Established knowledge of equipment qualification and sample logistic processes
- Established knowledge of validation of computerised systems.
- Ideally have detailed knowledge of CMC lot release/stability studies/ drug development process
If you are professional, forward thinking, enthusiastic and highly motivated, then we want you to join us and help us achieve our mission – to be the best company to work with and the best company to work for.
. Generous holiday allowance
. Excellent training & development opportunities
. Pension contributions
. Life Assurance
. A range of flexible benefits to suit your lifestyle
Req ID: 6187
Location: Huntingdon, UK
Department/Division: Bioanalytical & Translational Sciences