Study Director, Biopharmaceuticals

On Application
25 Sep 2018
02 Feb 2019
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

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group.