Laboratory Manager

1. Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases.
2. We are currently seeking a Laboratory Manager to join our Laboratory Services Department.
3. 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.

Req ID: R-01332

About Us:

Simbec-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 quality.our Laboratory Services Department.

Key Accountabilities:

• 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