Job Description

As a Technical Project Manager you’ll work as part of the our Project Management Team to provide technical support for Subcontract and in house work, providing technical support for internal stakeholders, clients, ongoing studies and ensuring technical compliance to various different regulations.

Key Accountabilities;

• Perform all duties and tasks in accordance with relevant Good Manufacturing and Good Laboratory Practice guidelines.
• To provide technical support to Outsourced Testing Manager on subcontract studies.
• Technical and regulatory support to clients on all aspects of studies.
• Review of paperwork to ensure sample types are appropriate for testing.
• Perform internal review of client paperwork to assess and complete biological and GMO risk assessments and appropriate notifications in a timely manner to receive and release testing samples.
• Ensure shipping permits are acquired from subcontractors in a timely manner (F&W/CITES/USFDA)
• Ensure export permits are acquired in a timely manner
• Review sub-contractor SOPs/Study Plans with QA, OTM and Operations Director to ensure the correct compliance – both regulatory and technical
• Support the Project Management team on any studies where issues have arisen
• To aid in shipping when required on multi-site studies when required in compliance with OECD Series on Principles of GLP and Compliance Monitoring, Number 13. The Application of the OECD Principles of GLP to the Organization and Management of Multi-site Studies.
• To conduct SOP construction and preparation, review and approval.

Required Knowledge, Skills, and Abilities

To be successful in this role, you’ll need a strong focus on virology with a solid scientific background and laboratory skills. In addition to the above you’ll also need to demonstrate the following; Previous experience of managing scientific projects or studies – Virology experience essential. Experience of working in a GLP/GMP environment. Experience managing subcontractors. Scientific background and laboratory skills relevant to TPM role – with a strong focus on Virology. Good communication and project management skills, verbal and written. Awareness of financial aspects of TPM role (shipping, revenue recognition etc.). Educated to degree level in a relevant discipline (e.g. BSc Hons in a biological science). Alternative equivalent level of expertise may be appropriate. The following attributes would be desirable, but not essential; Biologics logistical experience. Some experience in any of the following – in vivo, molecular or microbial. Experience preparing GMO risk assessment.