Formulation Scientist - County Waterford. Job Purpose: Responsible for formulation development of both Generic and New Drug Product development through: • Assisting with all R&D and Operations related formulation development activities ensuring strict adherence project plans. • Performing all activities required to ensure that all project milestones are delivered according to agreed timelines. • Applying a thorough knowledge of pharmaceutics to the development of drug products and the interpretation of in-vitro data to predict in-vivo performance. • Interpretation of in-vivo data for the purposes of further formulation development. • Carrying out pre-formulation and formulation development trials on high potency molecules where required. • Communication of project data through presentations at internal meetings and through formulation development reports. • Provision of guidance and lead pivotal scale cGMP exhibit batch manufacture based upon a sound knowledge of site and departmental SOPs, and an understanding of ICH/FDA/EMEA requirements as they relate to formulation and process development activities. • Maintaining a comprehensive knowledge of formulations and process development disciplines through research and scientific literature. • Identifying, assessing, recommending and implementing internal and external opportunities to broaden the company's technical/scientific capability. Core Responsibilities: 1. Project Planning: Together with the Formulation Development Manager and Formulation Development Team Lead, actively plan on-going formulation development requirements; ensuring major milestone targets for each project are visible to all team members and key stakeholders to achieve on time market entry. Together with the Formulation Development Manager and Formulation Development Team Lead, determine tasks required to deliver each project milestone by breaking them down into tasks; identify equipment, materials and people needed. Proactively build effective working relationships with Core Team and Functional Members. 2. Compliance: To ensure that work carried out is in compliance with required standards conforming to company, cGxP, SOPs, regulatory regulations & guidelines, Health, safety and environmental guidelines. 3. To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. Highlight opportunities for system optimisation to team members. 4. To support all on-going formulation and regulatory functions & requirements. 5. To complete all documentation correctly in order to achieve a high level of customer satisfaction and compliance to GMP. 6. To prepare reports and submission documentation in support of licence applications to various regulatory authorities. 7. To perform additional team tasks as agreed to support effective running of the Business. Minimum Qualifications & Experience requirements: Qualified to a minimum of honours degree level in Pharmaceutical science or related discipline. At least five years’ experience working in a formulation development, process development, manufacturing or related technical environment . Pre-formulation experience, including drug characterisation and ingredients selection. Formulation studies, considering such factors as particle size, polymorphism, pH and solubility, as all can influence bioavailability and drug activity. Process optimisation and scale-up experience are essential. Analytical/ laboratory experience would be advantageous. Have demonstrated effective research skills, including the critical review of the scientific literature. Knowledge of all drug product manufacturing processes is essential. Fill Finish and Dry Powder Inhalation (DPI) experience is advantageous. This job originally appeared on RecruitIreland.com.
70 days ago