A rapidly growing global pharmaceutical company that focuses on assisting in treatments for patients. They emphasize on providing patients access to affordable medicines to help with their treatments. Their R&D team focuses on developing innovative medicines and drug delivery systems.
Responsibilities:
- Operate on the pre-formulation/formulation/process development for sterile injectables or solid dosages
- Control formulation and process development on products that are commercialized
- Develop manufacturing processes based on QbD and DOE
- Create strategies to control related substances
- Act as a contact for CDMOs or CROs
- Draft high quality technical documents such as protocols and reports
- Draft and review SOPs
- Participate in drafting dossiers towards 505(b)(1), 505(b)(2), of 505(j) submissions
- Mentor peers and junior colleagues
Requirements:
- MUST have a PhD in pharmaceutics, pharmaceutical chemistry, industrial pharmacy, analytical chemistry, organic chemistry, or medicinal chemistry or MS. With 4-6 years of experience
- Experience with sterile injectable/parental products or oral solid dosages is a MUST
- Extensive understanding of pre-formulation and formulation studies
- Pilot-scale and manufacturing-scale experience is a plus
- Drug-device experience is a plus
- Strong English written and verbal skills
- Must be proficient in computer skills such as Microsoft Office tools
Other:
- Annual Bonus and Benefits
