Drug Substance MSAT Engineer
-
Downtown MRT, Downtown Core
- Sepenuh masa
S$5000 - 7000 / sebulan
Key Responsibilities
· Responsible for the technology transfer of antibody and conjugation projects. Write and complete technology transfer documents according to the project timeline, including but not limited to Facility/Process Fit, GARA, BOM, PFD, SPL, MBR, technology transfer reports, and campaign summary reports. Support new product introduction evaluation and ensure timely communication on the status of project technology transfer.
· Design and implement process validation protocols for antibody and conjugation projects. Write and approve validation reports while providing necessary on-site production support.
· Oversee and track the readiness of materials and equipment for GMP production.
· Support ongoing qualification, periodic review, and revalidation of commercial manufacturing projects in the plant.
· Manage internal and external communication related to the project. Keep clients and the CMC team updated on project progress and coordinate discussions on process and technical topics with clients.
· Write IND/BLA dossiers related to drug substrate (DS) manufacturing.
· Support or lead client audits and official inspections, and assist clients with Person-in-plant (PIP).
Requirements
· Bachelor’s degree or higher in life sciences or engineering, such as chemical engineering, bio-engineering, biology, or pharmaceutical science.
· Priority will be given to candidates with at least 3 years of relevant tech transfer experience in the production of large molecule drugs or conjugated drugs.
· Strong communication, teamwork, logical thinking, and execution skills, with the ability to work under pressure.
· Familiarity with GMP requirements and documentation practices
· Excellent English proficiency in reading, writing, and speaking, with strong meeting organization and document writing skills, bilingual ability (e.g., Chinese, Japanese, Korean) is a plus but not compulsory.
Beberapa kerja lain yang mungkin anda minati
Senior / Physiotherapist*(258) - National University Polyclinics
- Sepenuh masa
- Singapore
S$ 3500 - 5500 sebulan
Staff Nurse/Senior Staff Nurse - National University Polyclinic
- Sepenuh masa
- Singapore
S$ 2600 - 5200 sebulan
Technical Assistant (Clinical) / 5 Days / Bonuses - JH
- Sepenuh masa
- Singapore
S$ 2000 - 3000 sebulan
Kembali 
