Product Development Scientist - Ireland
Want to know company name or location? Company managed [?]
- Our company has a commercial presence in over 90 countries and has proven expertise in areas such as Oncology Supportive Care, Gastrointestinal, and Pain and Inflammation medicines.
- This job is based at the Group's finished pharmaceutical manufacturing plant.
- our company develops, manufactures and packages finished dose forms in tablet, granulate, capsule and gel formats.
- In addition, the company carries out final packaging of special dosage forms such as sterile forms and soft-gel which are produced by its worldwide network of CMOs.
- Perform tasks with a focus on oral formulation of conventional and controlled release solid dosage forms using the following processes (as applicable to on-going and future projects):
- High Shear and Fluid Bed Granulation
- Roller compaction
- Oral Liquid Formulation
- Identify and implement formulation and process development/optimization programmes with clear objectives, participate and lead project team meetings and act as a role model for high standards of performance.
- Develop Design of Experiment (DOE), interpret results and issue relevant documents.
- Supporting new product introduction, scale up and commercialization of manufacturing processes.
- Continue to develop knowledge in relevant areas and expand breath of knowledge, including areas outside of direct function, with a view to transferring to others.
- Support the preparation of formulation/process development documentation (e.g. CMC sections of IND, NDA, CTD) to support global regulatory filings.
- Minimum of a level 9 in a Life Science qualification
- At least 5 years’ of relevant work experience in pharmaceutical product development
- Experience in physical chemistry techniques and applications.
- Ability to critically analyse and interpret bioanalytical and physiochemical data.
- Excellent interpersonal and communications skills (written and verbal)
- Excellent project management and time management skills with ability to work to strict deadlines.
- Strong leadership skills and ability to work within cross-functional teams.
- Strong technical writing skills
- (Chemistry/Physics/Formulation Chemistry/Industrial Chemistry/Pharmaceutical Sciences/Pharmacy)
- Oral Formulations
- New Product Introduction
- Design of experiments / Statistical Analysis of results
The following knowledge, skills, qualifications and experience are desirable.
- MSc qualification.
- Experience leading technical teams.
- Experience of liquid/ointment formulations
- Experience of supporting regulatory filling of new products US/EU (IND/NDA)