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Product Development Scientist Dublin Ireland,  

Helsinn (company)


Posted on : 28 May 2017

Project Description

Description
  • 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.


The successful candidate will;
  • 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
    • Tableting
    • Coating
    • Encapsulation.
    • 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.



The Person/Requirements
The successful applicant will possess the following knowledge, skills, qualifications and experience.
  • 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)

Locations

Dublin

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