A leading pharmaceutical company that accelerates the launch and listing of drugs across China is seeking for a Formulation Engineer to join their office in Shanghai. The organisation, which is a subsidiary of an international pharmaceutical corporation, specialises in increasing China's core competitive power in the innovation of new drugs. This is an exciting opportunity to work with a prestigious company that develops first-class drugs.
- Serving as formulation lead of new drug development projects and providing technical expertise on formulation and process development/optimization.
- Interfacing with CDMOs, suppliers, and internal clients.
- Efficiently communicating with different functional stakeholders to align the work priority and the production timeline.
- Designing and reviewing experimental protocols independently or with CDMOs.
- Conducting formulation and process development of conventional and enabling formulations with the quality by design (QbD) principle.
- Managing all GMP manufacturing activities including clinical, registrational, and validation batches at CMO or internal sites.
- Writing and editing pharmaceutical and formulation development report to be included in CMC dossiers.
- Joining QA audits to qualify potential CDMOs from process perspectives.
- Preparing for Pre-Approval Inspection (PAI) leading to NDA approval.
Skills and Requirements:
- BS/MS/PhD in Pharmaceutical/Chemical Engineering or related scientific fields.
- At least 3 years of industrial experience.
- Hands-on experience in drug product formulation design, process development, and large-scale manufacturing.
- Experience in process unit operation including encapsulation, tablet compression, dry granulation, high shear wet granulation, fluid bed granulation, and coating.
- Experience in experimental design and reviewing of manufacturing/packaging/labeling batch records.
- Experience in enabling formulations e.g. spray dry dispersion, hot melt extrusion, nano formulation, lipid-based emulsion formulation, as well as controlled release formulations is a plus.
- Familiar with production equipment from pilot to commercial scales.
- Familiar with compliance requirements for formulation or process changes during development.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Lily Zhao at +86 21 51694106 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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