Summary of Job
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.
ESSENTIAL DUTIES & 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].
