- Manage day-to-day operations of all assigned departmental responsibilities, ensuring client expectations are met for all client projects.
- Manage, coach, and mentor direct reports to achieve assigned objectives measured by appropriate Key Performance Indicators.
- Manage, develop, and monitor the team's competence, identifying and addressing their training/development needs in collaboration with other stakeholders, ensuring appropriate records are maintained in line with company expectations.
- Manage, develop, and monitor the team's capacity and experience, engaging in authorised recruitment and onboarding to maintain adequate resources to meet the assigned objectives.
- Manage, schedule and monitor the team's productivity and day-to-day activities, ensuring company and client expectations are met for all projects.
- Manage, develop and record all departmental processes in line with the expected time/cost/quality requirements and data integrity guidance.
- Manage commercial development activities, ensuring company and client expectations are met.
- Manage, effect, and monitor communication about the status of work performed with intra-departmental stakeholders, Project Managers, Sponsors, and other stakeholders.
- Manage compliance with all related regulations and guidelines, including Scientific, H&S, Quality, Legal, etc, where appropriate.
- Manage, with participation as appropriate, departmental tours, audits and discussions relating to Laboratory Services with the Sponsor and other internal/external stakeholders.
- Collaborate with other Line Managers to support onboarding new Laboratory Services employees.
- Ensure facilities, equipment, and workstations meet a compliant and presentable standard.
- Fulfilment of reasonable requests to perform occasional operational work.
SKILLS REQUIRED
ESSENTIAL- Science or Business degree or equivalent
- Significant previous experience in leading/managing a team within a regulated laboratory environment
- Experience in managing multiple projects and managing competing priorities, ensuring the delivery of results on time and within budget
- Excellent verbal and written skills, with the ability to tailor communication to a variety of internal and external stakeholders
- Significant previous experience working in a regulated environment (IS0 17025, 15189 or MHRA GLP/GMP/GCP)
DESIRABLE- MSc, PhD or MBA in a relevant discipline
- Experience in research work and/or relevant experience gained using similar scientific and analytical techniques
- Experience in streamlining and improving operational processes
- Project management/Six Sigma/Lean certification
- Good understanding of MHRA Phase I Accreditation scheme requirements
- Working knowledge of laboratory testing in a GLP/GMP/GCP environment
WHY YOU SHOULD JOIN US
Simbec-Orion is growing fast. To keep up with demand, we're looking for the best people, from all areas of clinical development, to join our team.
We're dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it.
With experts from all disciplines under the same roof, you'll work alongside some of the industry's best. So if you'd like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We're waiting to hear from you. -
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Laboratory Manager - Merthyr Tydfil (Merthyr Tudful), United Kingdom - Simbec-Orion
Description
ABOUT USSimbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.
With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives.
THE ROLE
We are currently seeking a Laboratory Manager to join our Laboratory Services Department. In this role, you will be responsible for leading an operational team that provides a range of services related to laboratory analysis within clinical trials for our clients. This includes managing people, service outputs, processes, equipment, facilities, resource allocation, and ensuring regulatory compliance of the services provided to clients. As a Delegate (where required), you will promote the department during the acquisition of new work and support the development of employees within the Laboratory Services department. You will also collaborate and support other Laboratory Managers, Principal Scientists, and/or Senior Laboratory Project Managers to ensure that services are planned, properly resourced, managed, and executed in accordance with appropriate Key Performance Indicators related to time, cost, and Laboratory Services Department. In this role, you will leading an operational team for the provision of a portfolio of services associated with laboratory analysis within Clinical Trials for clients. Has accountability for areas that may include people management, service outputs, processes, equipment, facilities, commercial development, resource management, and regulatory compliance of the service provided to clients, ensuring they are maintained to a standard aligned with company expectations. Acts as a Delegate (where required) of Laboratory Services to promote the department during the acquisition of new work and supports the development of employees across the Laboratory Services department. Liaises and supports other Laboratory Managers, Principal Scientists and/or Senior Laboratory Project Managers to ensure the relevant services are planned, appropriately resourced, managed, and executed according to appropriate Key Performance Indicators centred around time, cost and quality.
KEY ACCOUNTABILITIES
