Study Director, Biopharmaceuticals
- Contract Type
The successful candidate will report to the Analytical Services Department Manager and will have the following responsibilities:
? Draw up study plans and implement studies in strict accordance with study plan ensuring full GMP regulatory compliance as appropriate.
? 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 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.
? Research and develop new analytical methodologies to meet client requirements and/or company strategic objectives.
? Ensure all new methods are validated in accordance with ICH guidelines, where appropriate.
? 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.
Applications are invited from candidates with the following background and experience:
• PhD in a relevant science discipline (e.g. Immunology, 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.
• Experience in analytical methods.
• Experience in analytical techniques (e.g. HPLC, UPLC, SDS-PAGE, Western Blot, qPCR, ELISAs) essential.
• Ability to project manage multiple studies.
• Knowledge and experience with statistical software.
• Ability to problem solve and work on own initiative.
For more information and to apply for this role please call me on 01 2784671 or e-mail firstname.lastname@example.org
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com