CMC Lead

Moleac is passionate and has made advanced progress in developing pharmaceutical-grade natural products with robust CMC and research that is moving into phase II under the US FDA botanical drug IND. We own our manufacturing process and patented know-how which we deploy and maintain with our long-term CMO partners.

We are seeking a highly motivated and skilled Pharmaceutical Engineer as CMC lead to join our team. The successful candidate will play a pivotal role in the design, development, and manufacturing of new and current pharmaceutical products. This position requires a deep understanding of pharmaceutical processes, regulatory guidelines, and QA/QC.

If you are a dedicated professional with a passion for developing innovative pharmaceutical products, we encourage you to apply.

Key Responsibilities:

• Drug Formulation and Improvement: Collaborate with cross-functional teams to optimize, improve or introduce new drug dosage delivery forms and/or packaging. This includes developing investigational products for clinical trials (Placebo, blinding of active product, etc).
• Process Development: Collaborate with CMOs to optimize and maintain pharmaceutical manufacturing processes that ensure efficiency and quality with international regulatory standards.
• Quality Control: Develop and implement specifications, quality control methods and protocols to monitor and ensure product quality
• Regulatory: Stay up-to-date with pharmaceutical regulations and ensure that all manufacturing processes and products adhere to relevant standards.
• GMP Adherence: Maintain adherence to Good Manufacturing Practices (GMP) and develop and update standard operating procedures (SOPs) as needed.
• Validation: Develop and execute validation protocols for manufacturing processes, equipment, and facilities to ensure consistent product quality.
• Research and Development: Participate in R&D activities, in particular developing fingerprint/analysis assays and analyzing data
• Work with QA to perform investigation into product complaint reports and product quality issues, identify root causes and propose and implement solutions promptly.
• Documentation: Prepare and maintain accurate and comprehensive documentation (SOPs, records/reports) of CMC and quality-related processes, experiments, and validations for regulatory and quality assurance purposes.
• Collaboration: Work collaboratively with multidisciplinary teams, including regulatory affairs specialists and QA, responsible for providing CMC documents
• Author and/or provide CMC dossier required for registration and variation submission and regulator’s input requests, within the agreed timeline/ regulator deadline
• Assist in liaison with CMC vendors (e.g. CMO partner) to provide site-specific documents essential for registration and variation submission
• Liaise with CMC vendors (e.g. CMO partner) to devise and perform tests/procedures requested by various regulatory authorities, for product registration, license life-cycle management and all Moleac’s business purpose
• Continuous Improvement: Taking ownership to identify opportunities and collaborate with relevant stakeholders for process optimization, cost reduction, and quality enhancement, and implement improvements accordingly.

Skills: FDA, Quality Control, Regulatory Compliance, Regulatory Affairs, Software Project Management, manufacturing processes, Process Simulation, cGMP, PIC/s GMP, Formulation, drug delivery, Research And Development, Medical Affairs, Process Optimization, Pharmaceuticals, Teamwork Skills, CMC Dossier Writing, Regulatory Submissions

Qualifications:

• Bachelor's or higher degree in pharmaceutical engineering, phytochemical engineering a plus.
• 5 years + of experience in pharmaceutical manufacturing of oral products or process development.
• Strong knowledge of pharmaceutical regulations, including PIC/s GMP and US FDA guidelines.
• Proficiency in data analysis and statistical tools.
• Excellent communication and teamwork skills.
• Detail-oriented with a commitment to quality and safety.
• Problem-solving and critical thinking abilities.
• Mandarin language (Business and technical level) to liaise with CMOs.
• Experience with health authority inspections/audits, and regulatory submissions.
• Knowledge of pharmaceutical equipment and facility design.
• Project management skills.

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].