Basic Functions:
- Leads a group for the production of recombinant proteins and the development of new materials and new process to facilitate assay design and developments, co-ordinate stability studies and marketing supports (trouble shooting assays).
Duties:
- Leads the production of in-house recombinant proteins to support the production of company products and to lead the processes development for production and purification of the new proteins (such as HCV antigens including NS5 & HIV antigens including gp36 & gp105 and other recombinant proteins required by newly developed products).
- Manages new material development on recombinant protein and labeling or conjugation to facilitate future generation product development.
- Maintains and implements ISO 13485 / FDA QSR 21 CFR: PART 820 and other relevant International standards and regulations.
- Ensures necessary and effective support for operations and marketing on technical issues, customer special requirements, complaint and problem solving.
- Co-ordinates and reviews stability studies to support product registration and shelf-life extension.
- Assists new product clinical trials and new product transfer and provide necessary supports such as developing procedures and standards for product launching.
- Conducts initial review for study protocols & reports and other documents to support R&D projects prior to external review.
- Provides adequate and appropriate training for subordinates
- Other projects/tasks assigned by the Research & Development Department Head.
- Implement and maintain Biosafety measures within the facility.
- Ensure compliance to Biological Agents and Toxins Act, Singapore.
Requirements:
Ability to : Supervise and lead a team of Research Technologists in carrying out their task.
Knowledge of : Molecular cloning, recombinant production, protein labelling, enzyme conjugation and product development.
Education : PhD; MSc/MEng; Good Honors degree; or equivalent.
Experience : PhD with >5 years of relevant work experiences; MSc/MEng with >8 years of relevant work experiences; Good Honors degree with >10 years of relevant experience & good track record in product development.
