Department: CMC & Supply Chain
Location: Singapore
Working as a SME (Subject Matter Expert) that will be involved in manufacturing process and quality control analytical methods improvement, technical support for manufacturing activities internally, network and collaborate with academia externally.
ESSENTIAL DUTIES & RESPONSIBILITIES
CMC Support
- Compile, analyse and present chemical, manufacturing control, biological testing related data in a concise manner for review with the project team and decision;
- Develop improved understanding of the process and analytical techniques in building CMC dossier to support discussion with authorities;
- Responsible for compiling and preparing quarterly reports of CMC developments for all projects;
- Source and select new external CRO/vendor/suppliers, participate in qualification of selected CRO/vendor/suppliers, in collaboration with QA;
- Provide technical support for clinical and non-clinical activities;
- Provide technical support for patent filing
QC support
- Perform timely batch release of raw materials and finished product to ensure commercial order fulfilment;
- Ensures timely update of manufacturing master batch records to ensure GMP compliance;
- To be on site to observe the production to ensure the contract manufacturer to produce Moleac’s products as per requirement if needed;
- Investigate deviations, propose and execute strategies to resolve quality investigations;
- In collaboration with QA, perform investigation for customer complaint;
- Develop and maintain relevant department SOPs
Qualifications:
- Degree/Master/PhD with a minimum of 3 years of experience in pharmaceutics, chemical engineering, chemistry, or allied disciplines. Exceptional candidates with less experience will also be considered.
- Solid knowledge in modern analytic, various spectroscopic and chromatographic analytical method is required.
- Previous experience working in a cGMP environment with in-depth knowledge of cGMP and relevant quality management systems will be an added advantage.
- Excellent oral and written communication skills. Knowledge of Chinese/Mandarin is essential to liaise with external CMOs and partners.
- Previous experience within CMO, or CDMO preferred.
- Ability to prioritize and manage multiple projects and activities while meeting tight deadlines
- Proven ability to think critically, proactive in problem-solving and able to independently manage timelines and priorities.
- The candidate will be required to travel on a periodic basis.
If you believe you are a suitable candidate for this position, please send your CV and a cover letter (detailing your interest in the position, availability, last drawn salary, and salary expectations) to [email protected].
