Essential Duties & Responsibilities
CMC Support:
- Compile, analyze, and present data related to chemical, manufacturing control, and biological testing in a clear and concise manner for team review and decision-making.
- Develop a deeper understanding of processes and analytical techniques to build comprehensive CMC dossiers for discussions with regulatory authorities.
- Prepare and compile quarterly reports on CMC developments across all projects.
- Identify and select new external CROs/vendors/suppliers, and assist in their qualification in collaboration with QA.
- Provide technical support for clinical and non-clinical activities.
- Offer technical assistance for patent filings.
QC Support:
- Ensure timely release of raw materials and finished products to meet commercial order requirements.
- Update manufacturing master batch records promptly to maintain GMP compliance.
- Observe production processes on-site as needed to ensure contract manufacturers adhere to specifications for Moleac’s products.
- Investigate deviations, propose and implement solutions to address quality issues.
- Collaborate with QA to investigate and resolve customer complaints.
- Develop and maintain relevant department SOPs.
Qualifications:
- Degree, Master’s, or PhD in pharmaceutics, chemical engineering, chemistry, or a related field, with at least 3 years of relevant experience. Exceptional candidates with less experience will also be considered.
- Strong knowledge of modern analytical techniques, including various spectroscopic and chromatographic methods.
- Experience in a cGMP environment and familiarity with cGMP and relevant quality management systems is advantageous.
- Excellent oral and written communication skills. Proficiency in Chinese/Mandarin is essential for liaising with external CMOs and partners.
- Prior experience with CMOs or CDMOs is preferred.
- Ability to prioritize and manage multiple projects effectively while meeting tight deadlines.
- Strong critical thinking skills, proactive problem-solving abilities, and capability to independently manage timelines and priorities.
- Willingness to travel periodically as required.
Please be informed that if you are interested in applying for a position, please email your resume in either Word or PDF format to [email protected]. In your resume, kindly include the following details:
- Current Salary:
- Expected Salary:
- Availability:
- Reason for leaving your current job:
Thank you for your application. Please note that only shortlisted candidates will be contacted for further consideration.
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EA (23S1595/R23116355)
