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Details

R&D Principal Scientist (Product Development and Launch)


Reference:JC/HQ00001902 Location: Galway
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed


R&D Principal Scientist (Product Development and Launch)

Our client a global pharmaceutical company with a very strong pipeline of products are currently seeking an R&D Principal Scientist to work on the development of and launch of injectable products. This is an exciting opportunity to work in an expanding R&D facility. Reporting to the R&D Director of Formulation Development the position functions autonomously with direction from R&D management and will directly supervises R&D employees where required and has a matrix responsibility for cross functional site or third party teams. The R&D Principal Scientist (Product Development & Launch) will be accountable for coordinating and leading Injectable process development for scale up and launch
Role/Responsibilities
Accountable for successful scale up of registration manufacturing process to commercial scale assigned to site or other nominated internal/third party site;
Partners with R&D development team in selection of a commercially viable Injectable process
Provides expert guidance to R&D scientists on Injectable process development
Reviews and approves the R&D nominated registration process is suitable for scale up
Supports process related responses to deficiencies to different regulatory agencies
Assesses new technologies for manufacture of injectable products
Supports and drives smart initiatives within the R&D department across product development (i.e. platform selection of filters and Single Use Systems). This role will also require the review and set up of management systems and processes to support current and future needs of product development and launch functions.
QbD SME for Injectable R&D;
Keeps updated on QbD requirements and expectations of regulatory agencies
Provides QbD expertise and guidance across global R&D injectables
Sets up QbD process and systems for a standard approach across Injectable sites
Leads and co-ordinates activities on scale up in preparation for registration or process validation at Galway site or other nominated internal or third party site;
Leads cross functional site teams to prepare for registration or Process validation batches
Leads and supports all product technical transfer activities from development to commercial (within the, across network and with third parties)
Preparation of Technical transfer reports to support seamless transfer of formulation/process to receiving site.
Co-ordinates cross functional activities to meet agreed delivery dates
Prepares a monthly pipeline overview for senior management in R&D, site operations and as input to launch management team
Prepares plans and budgets for R&D activities to support process validation;
highlighting risks for sunk costs on launch stock to support launch team management
highlighting relevant capital expenditure to support transfer and commercialization at receiving site
Supervises and mentors R&D, operations staff supporting commercial scale up activities
Operates in accordance with Company GMP and EHS procedures.
Perform other duties as assigned.

Skills/Experience
Minimum of a scientific Bachelor's degree (Engineering/Physics/Chemistry/pharmaceutical sciences) with 8+ years’ experience in the development or manufacturing of sterile products. Additional postgraduate qualifications are advantageous.
Must possess process and manufacturing knowledge of Injectable processes (Aseptic and TS) for a wide range of products (Solutions, lyophiles, suspension’s, controlled release injectable dosage forms) with experience of having multiple complex products approved with successful scale up for launch. In addition expertise is required in application of QbD principles to process development activities.
Track record of showing how results were delivered through management/leadership of others.
Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Management of resources and budgets
Development and training of team members.
Excellent communication skills (verbal and written).
Proficient computer skills (Excel, word, powerpoint, databases).



James Cassidy | Tel: +353 (0) 1 5079250