Pharmaceutical Development Engineer

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:

1. Current Salary:
2. Expected Salary:
3. Availability:
4. 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)