Project Leader | Mayo

Recruit Island; Calgary; On-site; CAD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a dynamic Project Leader to oversee method transfers and validations in a GMP-regulated environment. This role involves managing multiple studies, ensuring compliance with ICH guidelines, and liaising with clients. The ideal candidate will have a PhD in a relevant science discipline and at least three years of experience in scientific research, particularly in the pharmaceutical or medical device sectors. Join a forward-thinking company that offers excellent career progression opportunities and a generous compensation package, making a significant impact in the life sciences field.

Qualifications

• PhD in relevant science discipline required.
• 3+ years experience in GMP regulated environment preferred.

Responsibilities

• Oversee method establishment and validation in compliance with ICH guidelines.
• Manage project progress and provide technical training.

Skills

Project Management

Problem Solving

Statistical Analysis

Analytical Techniques

Molecular Biology Techniques

Education

PhD in Chemistry

PhD in Biochemistry

PhD in Biotechnology

Tools

Statistical Software

Job description

Project Leader | Mayo

• Leading Pharma Company in the West of Ireland
• Excellent career progression opportunities along with a generous package
• Oradeo Recruitment is presently seeking interest for a Project Leader to join our clients in Mayo.

The main duties & responsibilities shall be:

• Oversee and lead the establishment/transfer of multiple methods from client to our test labs across a number of different disciplines.
• Ensure all new methods are validated in accordance with ICH guidelines, where appropriate.
• Draw up study plans and execute studies in strict accordance with study plan and SOPs ensuring full GMP regulatory compliance, where appropriate.
• Liaise with the Quality Department for the generation of audit responses, deviation reports and for the compilation of study reports.
• Responsible for leading laboratory investigations, where necessary.
• Responsible for reporting project progress information to Management.
• Provide technical training to scientific team, as required.
• Day to day liaison with clients regarding current and new projects.
• Involvement with regulatory and client audits.
• Ensure all new equipment is qualified and validated in accordance with GMP and corporate validation requirement standards and guidelines.
• Generate new and update current standard operating procedures, where required.
• Generate risk assessments for drug products, substances and processes as required.

The following are minimum requirements related to the Project Leader position:

• PhD in a relevant science discipline (e.g. Chemistry, Biochemistry or Biotechnology)
• A minimum of 3 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.
• Experience in study design, assay development, optimization, ICH analytical validation and project management essential.
• Experience in analytical techniques, Molecular biology techniques e.g. PCR and Q-PCR or Cell Culture Techniques and Virology desirable.
• Ability to project manage multiple studies.
• Knowledge and experience with statistical software.
• Ability to problem solve and work on own initiative.

For more information about this Project Leader position or other opportunities, contact Angela Haran at Oradeo Recruitment confidentially on [phone] or apply in confidence.

About Oradeo - Oradeo Recruitment are specialists in the life sciences, pharmaceutical, construction & engineering sector. We are a leading service provider in Ireland, UK and Europe for professional recruitment services and the provision of managed labour in Construction & Civil Engineering, Data centres, Mechanical & Electrical, Life Sciences and Renewable Energies sectors.