Cache of job #4999683

Job Title

Development Scientist

Employer

Pe Global

Location

Dungarvan, Waterford

Description

Development Scientist. Role overview: A technical specialist in a range of products and their associated manufacturing and analytical processes, performing routine troubleshooting, investigations & continuous improvements, informal risk assessments. Reporting to the Principal Scientist, the development scientist will design and execute laboratory studies in a state of the art fill finish development laboratory with a view to transferring the developed process to manufacturing via the New Product introduction team. The development scientist will also work on and lead technical life cycle management (TLCM) projects associated with the current and future commercial drug products. Relevant experience in the development of fill finish processes for biopharmaceutical drug products; Experience in a GMP regulated environment. Experience one or more of the following – Protein manufacturing Science , Lyophilisation, Formulation, Technology Transfer, Scale Up, Fill finish processes and technologies, QbD, PAT. Desired Skills / Knowledge. Fundamental understanding of how manufacturing process can impact Critical Quality Attributed (CQA). Provides guidance and mentoring to site teams as appropriate. Good understanding of biopharmaceuticals, protein science , stability. Experienced in Formulation and Lyophilisation Cycle Development. Has direct observational experience of full-scale manufacturing processes and associated key analytical techniques. Can translate asks from key stakeholders into a process development work programme. Can leverage existing product history, peer-review and benchmarking approaches to inform efforts. Can execute to a high standard already designed experimental studies and prepare reports intended for final audience. Experience in product & protein characterisation techniques for example – CD, FTIR, Fluorescence Spectroscopy, HPLC, ELISA, SDS-PAGE, mDSC, FDM, DVS, TGA, Nephelomoetry. Solid State techniques such as pXRD, SEM, BET would be an advantage. Experienced with regulatory bodies and writing pharmaceutical development sections of a product filing. Understand impact of development strategy/ process changed to the regulatory filing of a biopharmaceutical product. Project Management experience; Risk Assessments. Technology Transfer & Scale up; application of statistical tools and mathematical modelling to support these activities. Knowledgeable on the fill finish manufacturing processes for the product and the interactions between product and process that impact CQAs and long term stability. Proficient in fill finish manufacturing science, technologies, techniques and framework to enable successful process development; relates efforts and approaches to best-practices & business asks; capable of working on a new manufacturing technology platforms. Can identify gaps in drug development histories and recommend approaches for gap analysis and remediation. Is up-to-date on current manufacturing processes; can identify specific tools to assist in the construction and execution of process development studies; able to draw on range of history, SME interview and experimental design approaches to inform recommendations. Execution of work reflects needs and wants from end-user & stakeholder groups while maintaining scientific excellence of approach. Has experience of interactions with other scientists within network to share best-practice/lessons learnt. Can relate theoretical predictions to actual observations. Has demonstrated understanding and application of relevant Compendial and Pharmacopeial standards to their specification of interest. Can review on-going product data (e.g. Periodic Product Performance, Change Control, Process Control Strategy, QC stability trends, Development studies) and make recommendations to changes/enhancements to existing specifications based on risk assessment techniques. Can support the technical lead in the delivery of the process development Technology transfer activities. Understanding of ICH Guidelines Q8, 9, 10; Quality by Design (QbD); Pharmaceutical Development. Can interpret results, trends, investigations, can troubleshoot method and equipment issues, working logically and systematically to resolve problem. Will be required to present ideas in a manner that will gain buy-in from major cross functional stakeholders to facilitate implementation of solutions. Comfortable to present at industry forums and answer questions as they arise. May prepare industry papers as required and appropriate. Skilled problem solver. Excellent Communication Skills – continually communicating to stakeholders both internally and globally. Can present findings of work professionally & objectively. Qualification. BSc or equivalent. Preferred PhD. Experience : At least 8-12 years’ experience in a relevant pharmaceutical or biopharmaceutical role. To Apply for this position please forward your CV to Gary McGrath at PE Global or call me on 0214297900 to discuss in more detail.

Date Added

3501 days ago

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