- To coordinate and lead all R&D and Operations related formulation development activities and to ensure strict adherence project plans.
- To perform all activities required to ensure that all R&D project milestones are delivered according to agreed timelines.
- To work closely with PMO to ensure all work stream leads are appointed to all ongoing projects and all planned tasks are being progressed.
- Apply a thorough knowledge of pharmaceutics to the development of drug products and the interpretation of in-vitro data to predict in-vivo performance.
- Interpret in-vivo data for the purposes of further formulation development.
- Communication of project data through presentations at internal meetings and through formulation development reports.
- Provide 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.
- Maintain a comprehensive knowledge of formulations and process development disciplines through research and scientific literature.
- Project Planning:
- 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.
- Determine tasks and resources 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 follows required standards conforming to company, cGxP, SOPs, regulatory regulations & guidelines, safety and environmental guidelines.
- Initiate action to correct quality/schedule problems or notify others of quality issues as appropriate. If a procedure does not exist, devise one; if a process needs amending, do so.
- 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 cGMP.
- To prepare pharmaceutical development 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.
- Health & Safety
- Ensure requirements of 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
- If unsure about safety requirements – ask
The ideal candidate will meet the following criteria:
- Qualified to a minimum of honours degree level in Pharmaceutical science or related discipline. Master’s degree would be advantageous
- At least five years’ experience working in a formulation development, or related technical environment
- Experience in effectively operating both GMP and Non-GMP areas
- Pre-formulation experience, including drug characterisation and ingredients selection
- Formulation studies, considering such factors as particle size, polymorphisms, pH and solubility, as all can influence bioavailability and drug activity
- Supervisory/ management experience essential
- Analytical/ laboratory experience would be advantageous
- Project management and team leadership skills are essential
- Have demonstrated effective research skills, including the critical review of the scientific literature
For a confidential discussion and more information on the role, please contact Eloísa Ruiz on 021 4911066 or email email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie