Role DescriptionAs a Scientist Analytical Developer, you will work with complex biological products that will needs to go through extensive quality testing before they can be released. Further more you will be responsible for supporting the quality testing of the products by using analytical methods (using the phase I/II clinical stage).
The main tasks of the analytical developer are:
• Support quality testing of the product and develop/ qualify Bioassays • Do a routine testing of development grade and non-clinical grade materials by implementation of these assays • Tweak, troubleshoot and monitor the performance of the assay
Responsibilities• You are also responsible for adequate reporting of assay qualification, assay development and validation • Responsible for the assay performance during the early stages of the assay life cycle (tweak, trend and troubleshoot) • Manage, plan and design qualification, assay development and validation (including hands-on time) • Responsible for reviewing the analytical results and obtain the data during early clinical phase and non-clinical • Responsible for updating the analytical package by using the novel analytical tools ( by using state of art techniques for product characterization) • Responsible for transferring assays to the QC environment during the subsequent of assay lifecycle (troubleshoot, support and validate) • Responsible for assisting the regulatory submissions (IND, IMPD and dossier variations)
Requirements• Technological (specific experience, publications) or scientific analytical development background is a must • Willing to work on the lab floor, so more hands-on work • Interest in qualification, validation and (bio) assay development preferable in vaccines or gene therapy • PHD in a life sciences related field • Experience with HPLC, Molecular biology, GMP, MS and managing technical staff • Knowledge with guidelines (Compendia, USP, PH. EUR FDA, EMA) and • Experience with similar type of work / group
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jayton Tiao.