R&D Formulation Support Scientist
About Chanelle Pharma:
Chanelle Pharma is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products.
Serving customers in 96 countries worldwide, Chanelle Pharma is a partner of choice in the development and manufacturing of pharmaceutical products to the world’s leading human generic and animal health multinationals and distributors. We are passionate about understanding and addressing the challenges facing our medical and veterinary customers and bringing them innovative and effective products and solutions.
This is an opportunity to be part of a dynamic team within the R&D function. We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers. This role reports into the R&D Formulation Manager.
• Support Senior Formulators in preparing and executing Lab development trials to support the successful development of formulation.
• Support R&D senior formulators and method development / validation analysts in planning and coordination of the formulation planning and testing.
• Prepare orders to R&D production, bill of materials, batch manufacturing and packaging documents, validation protocols/reports stability protocols under the guidance of Senior R&D Formulators.
• Provide support to Senior Formulators during development and scale-up and process designing of formulations for US/Europe/Canada/US/Australia and global markets.
• Assist Senior Formulators in the Co-ordination with external sites such as API sites, packaging sites, excipient suppliers etc., to research and identify suitable options for new developments.
• Support internal teams such as procurement, planning, manufacturing, QC, QA in R&D formulation activities.
• Perform site technical transfer activities from external sites.
• Support Senior formulation and R&D analytical teams in preparing technical responses to Customer and / or Authority deficiency questions on R&D developments.
• Prepare R&D Techpacks for new developed products and submit to Regulatory Affairs team.
• Draft Development reports for R&D products under the guidance of Senior Formulators.
• Ensure the formulation log books/experiment registers are documented completed and in full at all times.
• Co-ordinate with planning/production/validation/external and internal testing teams to ensure timely completion of process validation batches, Certificates of Analysis and associated reports.
• Co-ordinate with procurement/Engineering to ensure availability of required documentation and suitability of packaging materials on the exiting lines.
• Assist Senior Formulators in the execution of optimisation and pilot batches.
• Technical support to production for resolving any issues on the routine production batches.
• Support the R&D department in audits and inspections.
• Comply with all the relevant regulatory guidelines for European and US FDA, ICH guidelines for development, process validation and stability studies.
• Drive efficiency and effectiveness within the R&D team and the processes employed in R&D team.
• Knowledge of formulation development and tech transfer for the solid oral and liquid oral dosage forms in pharma companies in previous role/s.
• Knowledge on the regulatory requirements for EU/Canada/US/Australia and ROW.
• Establishes strong working relationships with others, building team rapport and creating a cohesive team environment.
• Displays a positive outlook with strong coaching skills, maintaining interest at all times.
• Takes a methodical, systematic and structured approach to organising work.
• Organisational skills, personal efficiency, time management skills and the ability to prioritise competing demands are key communication skills.
• Ability to build relationships and collaborate with others is vital.
• Makes effective and consistent decisions in a timely manner.
• Takes personal responsibility for making a decision and taking action within their own area.
• Escalates issues appropriately.
• Takes action to correct poor performance by being fair and consistent in approach.
• Displays flexibility, willingness to succeed and goes the extra mile.
The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.
• 3rd level Science / Pharmacy qualification as a minimum.
• Post- graduate qualifications in pharmaceutical sciences is preferable.
• At least 3 years experience in the pharmaceutical industry.
• Experience working within a pharmaceutical Environment; with knowledge of EU GMP and US FDA Guidelines.
• Excellent written and communication skills.
• Strong verbal and written communication skills.
• Strong computer skills in MS Office.