Immunoassay Project Leader
- Employer
- Thornshaw Recruitment
- Location
- Mayo (County), Connacht (IE)
- Salary
- Negotiable depending on experience
- Start date
- 16 Mar 2023
- Closing date
- 29 Mar 2023
View more
- Discipline
- Quality, GMP, Project Management
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
I am currently recruiting for an experienced Project Leader for my client’s Biologics Division located in Co. Mayo, Ireland.
This is a full time permanent position and can work a 4 day working week! Other benefits include but not limited to health insurance and pension.
This role shall report to the Biosafety and Bioassay Development Manager and the main duties & responsibilities shall be:
- Draw up study plans and implement studies in strict accordance with plan ensuring full GMP regulatory compliance.
- Liaise with the Quality Department for the generation of audit responses, facility replies, deviation reports and for the compilation of study reports.
- Responsible for leading laboratory investigations.
- 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.
- Research and develop new methodologies to meet client requirements and/or company strategic objectives.
- Responsible for generation of quotations for new studies and client enquiries.
- Manage and provide weekly and monthly sales figures for specific studies.
- Ensure all new methods are validated in accordance with ICH guidelines
- 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.
- Generate risk assessments for various projects as required.
- Act as Project Manager for in-vivo rodent studies.
PERSON SPEC:
- MSc. or PhD in a relevant science discipline (e.g. Biomedical Science)
- A proven track record and experience of working in a GMP regulated environment (EMEA/FDA) within the Pharmaceutical/Medical Device/CRO Industry.
- Experience in study design, assay development, ICH analytical validation and project management.
- HPRA project license authorisation desirable but not essential
- Experience in in-vivo Bioassays and model development.
- Experience in immunology, immunogenicity, toxicity and safety studies. (analytical techniques also would be an advantage).
- Ability to manage multiple studies
- Knowledge and experience with statistical software.
If you are interested in applying for this role, please call Zoe on +353 1 2784671 or email zhamilton@thornshaw.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com
Company
Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment. In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.
Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.
Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.
Our Industries
We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years.
Our Specialities
Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.
Our Mission
For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com
- Website
- http://www.thornshaw.com/
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