Study Director, Biopharmaceuticals

Location
Mayo
Salary
On Application
Posted
25 Sep 2018
Closes
02 Feb 2019
Ref
DB9922
Contract Type
Permanent

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 dbolger@thornshaw.com

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