- 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, comprising a team of line managers, senior laboratory service personnel, and indirect 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 daily 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, effect, and monitor communication about the status of work performed with intra- and inter-departmental stakeholders (e.g., HR Business Partner, QA representative, Financial Controller, IT representative), 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 Sponsors and other internal/external stakeholders.
- Collaborate with other Line Managers to support the onboarding of new 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 degree or equivalent
- Significant previous experience in leading/managing a team within a regulated laboratory environment
- Experience in project management and managing competing priorities, ensuring the delivery of results within expectations of time, quality and cost
- 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)
- Significant experience in managing GCLP or GLP/GMP studies
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
- In-depth 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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Operations 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 an Operations Manager to lead our Laboratory Services Department. In this role, you will manage a team dedicated to providing a range of services related to Clinical Analysis/Chemistry for our clients. You will have accountability for people management, Laboratory Service related projects, processes, facilities, equipment, resource management, and regulatory compliance of the service provided to clients. It will be your responsibility to ensure that all aspects of the service provided are maintained to a standard aligned with company expectations. In addition to this, you will serve as an ambassador of Laboratory Services, promoting the department during the acquisition of new work, and supporting the professional growth of employees across the Laboratory Services department. You will also liaise and support other Operations Managers to ensure that the right projects are planned, appropriately resourced, managed, and executed according to appropriate Key Performance Indicators centred around time, cost, and quality.a Operations Manager to join our Laboratory Services Department, where you leading a dedicated team for the provision of a portfolio of services related to Clinical Analysis/Chemistry for clients. Has accountability for people management, Laboratory Service related projects, processes, facilities, equipment, resource management, and regulatory compliance of the service provided to clients, ensuring they are maintained to a standard aligned with company expectations. Acts as an Ambassador 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 Operations Managers to ensure the right projects are planned, appropriately resourced, managed, and executed according to appropriate Key Performance Indicators centred around time, cost and quality.
KEY ACCOUNTABILITIES
