Principal Scientist - Formulations (OSD branded)
This Principle Scientist, Drug Product Formulation Position resides in Technical Operation department. The person in this role is expected to provide technical expertise in drug product development and formulation activities in order to support clinical studies in different phases. This role is expected to conduct both in-house formulation development activities and manage CMOs for formulation development and drug product manufacturing.
- Search/evaluate/develop drug product formulation/manufacturing technologies based on program needs.
- In collaboration with internal development team, conduct drug product formulation and manufacturing process development activities in the laboratory.
- Lead drug product development activities and serve as representative in CMC team.
- Provide technical support and day-to-day management of outsourced drug product development activities with CMO partners
- Manage manufacturing activities that will include monitoring production campaigns, reviewing of batch records, analytical data evaluation, etc.
- Author, review and approve GMP documents for clinical supply manufacturing
- Present technical data to CMC team, program team and senior management as needed
- Provide regulatory filings support by authoring and reviewing CMC sections
- Support any quality investigations or events and resolve them in a timely manner
- Demonstrated experiences on working with CMO for both drug product development and manufacturing (GMP).
- Extensive knowledge and hands on experiences on solid oral dosage formulation development, especially on solubility enhancing formulations, and/or controlled release formulations.
- Extensive knowledge and hands on experiences on solid oral dosage manufacturing process development with various technologies such as fluid bed coating/granulation, spray drying, hot melt extrusion, dry granulation, wet granulation, milling, tablet compression, tablet coating and encapsulation etc.
- Knowledge and the ability to use and understand data from common analytical techniques such as HPLC, DSC, TGA, XRPD, IR/Raman spectroscopy and particle size analysis techniques required to support product development
- Proven knowledge of cGMPs and associated regulatory, quality compliance considerations in the pharmaceutical environment.
- Demonstrated experience on authoring regulatory filing documents (CTD Module 3) for major regulated markets (US, EU, etc.)
- Ability to deliver results on time and within budget
- Excellent written and verbal communication skills
- Experiences on working within cross functional teams (analytical, process chemistry, quality, regulatory, clinical supply, etc.).
- Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering or other relevant discipline with 5-8 years pharmaceutical industry experiences, or a university degree in same disciplines with at least 12 years pharmaceutical industry experiences.