My client is a biopharmaceutical company specializing in the development of advanced therapies for neurological disorders, emphasizing neuroprotection and neurorehabilitation.
They are currently looking for a Pharmaceutical Development Engineer to be the Subject Matter Expert (SME) to focused on enhancing manufacting processes and QC analytical methods.
Responsibilities:
- CMC Support: Analyze and present data on chemistry, manufacturing control, and biological testing. Source and manage external CROs, vendors, and laboratories for product testing and process validation.
- QC Support: Oversee batch releases and ensure compliance with specifications. Update manufacturing records for GMP compliance and monitor production to ensure adherence to requirements.
- Technical Support: Provide technical assistance for clinical and non-clinical activities, patent filings, and CMC dossier preparation for regulatory discussions.
- Quality Investigations: Investigate deviations, resolve quality issues, and collaborate with QA on customer complaints. Develop and maintain relevant SOPs.
Qualifications:
- Bachelor in a relevant field, with strong knowledge in analytical methods and cGMP.
- Proficiency in Chinese/Mandarin is essential, and experience with CMOs or CDMOs is preferred.
- Experience in Quality Control Batch Release preferred
- Must be able to manage multiple projects, think critically, and travel as needed.
If you are interested, please apply with your CV attached.
