EirGen Pharma have a vacancy for a Formulation Scientist to join their R&D Team. Reporting directly to the Formulations Development Manager, this role will be responsible for formulation development of both generic and new 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 EirGen Pharma’s technical/scientific capability.
Responsibilities of this role will include:
- 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.
- 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.
Health and Safety:
- Ensure requirements of EirGen Safety Statement are implemented
- Continuously promote a positive safety culture by leading by example
- Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
- Report any defects
- 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.
- To support all on-going formulation and regulatory functions & requirements.
- To complete all documentation correctly in order to achieve a high level of customer satisfaction and compliance to GMP.
- To prepare reports and submission documentation in support of licence applications to various regulatory authorities.
- To perform additional team tasks as agreed to support effective running of the Business.
The Ideal Candidate:
- 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.