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CMC Lead

2 months ago

Singapore MOLEAC PTE. LTD. Full time
About the Role

Moleac Pte. Ltd. is a leading company in the development of pharmaceutical-grade natural products. We are seeking a highly skilled Pharmaceutical Engineer to join our team as a CMC Lead.

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.
  • Process Development: Collaborate with Contract Manufacturing Organizations (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 Compliance: 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.
  • 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 Quality Assurance, responsible for providing CMC documents.
  • Regulatory Submissions: Author and/or provide CMC dossier required for registration and variation submission and regulator's input requests, within the agreed timeline/ regulator deadline.
  • CMO Liaison: Assist in liaison with CMOs to provide site-specific documents essential for registration and variation submission.
  • Regulatory Liaison: Liaise with regulatory authorities to devise and perform tests/procedures requested for product registration, license life-cycle management, and all Moleac's business purposes.
  • Continuous Improvement: Take ownership to identify opportunities and collaborate with relevant stakeholders for process optimization, cost reduction, and quality enhancement, and implement improvements accordingly.
Requirements
  • 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.