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Formulation Scientist - PHD

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location:
  • Sector: Quality & Compliance
  • Date posted: 19/12/2017
  • Job reference: J379056A

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Development Scientist

A technical specialist in protein science and will be a key contributor to the Fill Finish development team and all programs of work. Reporting to the Principal Scientist, the development scientist will be the key protein/ biophysics SME.

The development scientists will develop, build and train other development scientists in the area of protein sciences. The development scientist will also work on and lead development & technical life cycle management (TLCM) projects associated with the current and future commercial drug products

Role overview:

  • Relevant experience in the development of fill finish processes for biopharmaceutical drug products
  • Experience in a GMP regulated environment
  • Experience in the following - Protein Science, Force Degradation, Stability in liquid and dried state, Protein Analytics, Biophysics & Biophysical Characterisation

Desired Skills / Knowledge:

  • Strong Biophysics background
  • Protein degradation assays
  • Protein Structure-function relationships
  • Protein biophysical structure determination methodologies
  • Good understanding of biopharmaceuticals, protein science, stability.
  • Experienced in Formulation and Lyophilisation Cycle Development in a plus.
  • Experience in product & protein characterisation techniques for example - CD, FTIR, Fluorescence Spectroscopy, HPLC, ELISA, SDS-PAGE, mDSC, FDM, DVS, TGA, Nephelomoetry
  • Method Development for R&D purposes
  • Experienced with regulatory bodies and writing pharmaceutical development sections of a product filing.
  • Project Management experience; Risk Assessments
  • Experimental Design
  • Technology Transfer & Scale up
  • Can relate theoretical predictions to actual observations.
  • 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
  • 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

Qualification:

  • MSc or equivalent
  • Preferred PhD

Experience:

At least 5 years' experience in a relevant pharmaceutical or biopharmaceutical role depending on academic qualification

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