R&DFormulation Scientist ABOUT XEOLAS Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 95+ employees.
We develop and manufactureinnovativepatient friendly pharmaceutical products for international markets.
We are now seeking an experiencedR&DScientist as weexpand our R&D department.
OVERALL ROLE OBJECTIVE TheR&DScientist will take responsibility for role in the formulation development, documentation of the developed formulation and tech transfer of pharmaceutical formulations.
This includes pre-formulation studies, formulation development, change control, SOP for formulation department, scale-up activities, manufacturing of exhibit and tech transfer batches, and preparation of technical documentation, protocols & reports in accordance with cGMP and internal quality standards.
SPECIFIC RESPONSIBILITIES Perform formulation development, pre-formulation studies, lab-scale trials, and scale-up to production.
Participate in the manufacturing of exhibit, qualification, and tech transfer batches as part of new product introduction (NPI).
Investigate and resolve formulation or process related issues encountered during tech transfer, qualification, exibit batch manufacturing.
Prepare and update technical documentation including batch manufacturing and packaging records, protocols, and technical reports to support product development and process qualification.
Develop or revise Standard Operating Procedures (SOPs) as needed.
Conduct R&D lab activities in accordance with GLP, GMP, and internal standard operating procedures.
Support R&D related audit activities.
Collaborate effectively with cross-functional teams including Quality Control, Quality Assurance, Production, Supply Chain, Regulatory, Engineering and others to support R&D and tech transfer activities.
Assist in the procurement of R&D raw materials & toolings and supporting reporting manager on important activities.
KEYSKILLS /EXPERIENCE REQUIREMENTS Minimum Degree inPharmacy or Chemistryor similar qualification.
Relevant experience within a GMP pharmaceutical environment will be added advantage 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 and communicate.
Excellent critical thinking and problem-solving abilities.
Strong interpersonal and communication skills Ability to work independently and collaboratively in a cross-functional team environment.
DESIRABLESKILLS /EXPERIENCE REQUIREMENTS At least 3 years of experience in R&D Formulation in a pharmaceutical environmentandGMP manufacturing, preferably within oral, non-sterile dosage forms is essential.
RelevantR&D Analytical experience in pharmaceuticals would be an advantage Relevant experience in clinical trial manufacture and associated GMP aspects including documentation would be an advantage.