職位描述
職位描述：
Description:
Support, execute and troubleshoot vaccine based formulation & downstream processes and strictly adheres to GLP, GMP, EMA and Chinese authorities standards and guidelines.
Participate in process scale-up efforts and support tech transfer to Operations
Engage hands on with laboratory activities under supervision, follows good documentation practices, review & analyse experimental data and author internal study reports.
Deliver experimental results within timeline and participate in technical discussions to support on-going research projects.
Proactive in collaborations with cross-functional units and BI partners across all sites.
Duties & Responsibilities
Support experiment for the ongoing research projects in GSP laboratory.
Support laboratory diagnosis following internal SOP
Conduct all necessary tests for the correlation in accordance with regulatory requirements and relevant guidelines to ensure their acceptance by Chinese authorities and EMA
Under the supervision, support standard protocols and procedures development
Routine maintenance of the laboratories. Manage the inventories of reagents, kits etc.
Keep detailed and accurate records and ensure these documentations are in compliance with all the regulations.
Assist in preparing relevant documentations for the regulatory review
Support Regulatory Affairs for dossier compilations, submissions, answering regulatory questions and oral hearings
Work closely with the R&D project teams to ensure alignment and best practice
Requirements:
Ph.D / MSc in Biotechnology, formulation sciences, bioengineering, chemical engineering, veterinary sciences OR BSc with 3-5 years working experience in Biologics industry
Knowledge in downstream vaccine bio-processing & formulation.
Expertise in more than one of the following technical area: clarification & concentration, purification, lyophilization/freeze-drying, adjuvant & emulsion.
Technical skills in viral-based formulation and lyo cycle optimization
Process scale-up/-down and transfer experience is a strong plus
Experience working in a multinational company and/or overseas experience with GMP knowledge pertaining to Biologicals industry is preferred.
Good interpersonal, communication and presentation skills
Flexibility and desire to work within a multidisciplinary team are required.
