ABOUT XEOLAS Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 80+ employees.
We develop and manufactureinnovativepatient friendly pharmaceutical products for international markets.
We are now seeking an experienced R&DProjects Executive as weexpand our R&D department.
OVERALL ROLE OBJECTIVE The R&DProjects Executive/Lead will take responsibility for projectmanagement of R&D Projects activities, internally and externally,including activities of formulation development and analytical development, as well as technology transfer activities.
SPECIFIC RESPONSIBILITIES Project Manage as R&D Projects executive/Lead, including but not limited to: Internal R&D Projects External R&D Projects Clinical / Pivotal Stability batches Project lead perform day to day activities of selected R&D projects to ensure delivery of the goals and objectives of the function.
Develop and manage associated R&D documentation and reporting systems so that R&D activities are effectively documented and reported.
Liaise with other departments including Laboratory, QA, Production, Engineering, Supply chain, Regulatory as appropriate to ensure delivery of the R&D programme.
Assist in the introduction and development of new technologies and equipment to support NPI from R&D into clinical / commercial as required.
Assist with external R&D collaborations andwith the evaluation of the R&D pipeline including input to feasibility, regulatory strategy and clinical strategy.
Provide regulatory input and assistance including generation of regulatory submission documentation as required Assist with the preparation of reports and other documents to support funding applications including grants, R&D tax credit applications, documentation to support Knowledge Development Box activities etc.
KEYSKILLS /EXPERIENCE REQUIREMENTS Degree in Pharmacy or Chemistryor Managment or similar qualification.
Relevant exerience within a GMP pharmaceutical environment will be added advantage Excellent Project Management Skills Knowledge and experiencedofequipment used for the manufacturing of oral, non-sterile Drug Products including powders for solution, powders for suspension, tablets (including dispersible and oro-dispersible) and sachets.
Experience in Injectable & creams will be added advantage.
Highly flexible, works well in a team environment, and has necessary skills to organize, mobilize, communicate, influence and lead.
Excellent critical thinking and problem-solving abilities.
Strong interpersonal and communication skills Experience in dealing with multiple stakeholders, both internal and external.
DESIRABLESKILLS /EXPERIENCE REQUIREMENTS R&D Project management, R&D Formulation experience and R&D Analytical experience in pharmaceutical GMP environment, preferably within oral, non-sterile dosage forms.