Senior R&D Formulator

CPL

GALWAY

KEY RESPONSIBILITIES: Perform the Lab development trials for successful development of formulation. Provide Technical support to formulation development and scale-up of solid dosage and liquid dosage formulations. Provide Technical support to boost evaluation of the new molecules which involves checking the feasibility of development and manufacturing within the in-house infra structure. Co-ordinate with Business development, registration and sourcing team to evaluate overall feasibility of new development. Comply with all the relevant regulatory guidelines. To drive efficiency and effectiveness within the medical R&D team. Prepare Techpacks required for registration of new developed products. Reviewing the orders to production, Assist in the transfer of R&D medical products into production. Preparation/Review and approval of all Development reports. Technical support to production for resolving any issues on the routine production batches. Represent the company at the time of audits. COMPETENCIES: Sound knowledge of formulation development and tech transfer for the solid oral and liquid oral dosage forms in pharma companies in previous role/s. Sound knowledge on the regulatory requirements for EU/Canada/US/Australia and ROW. A strong working knowledge of best practice processes, change management implementation. Strong computer skills in MS Office. QUALIFICATIONS: 3rd level qualification as a minimum. Post- graduate qualifications in pharmaceutical sciences is preferable. 8 10 years formulation development experience in the pharmaceutical industry. Experience in the formulation of medical oral solid & liquid dosage forms. Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines. Excellent written and communication skills. Contact Brenda on 0858723761, brenda.flannery@cpl.ie. Stamp 4 Visa Required for this role.

1358 days ago