A global pharmaceutical company is seeking a Senior Scientist/Principal Scientist to join their team to support formulation development (title/compensation dependent on years of experience, education, etc.). The candidate will be responsible for developing formulations and processes for new products in the R&D pipeline. The role will also involve communicating with CROs and internal functions to deliver project timelines. The ideal candidate will have a strong background in the pharmaceutical or biotech industry.
- Conduct or lead formulation and process development for new products in the R&D innovation pipeline. Conduct literature research supporting product development.
- Manage clinical supplies including shipping clinical supplies to CROs for clinical studies
- Communicate with CROs on routine basis regarding the retention and destruction of clinical supplies, bio samples, and original documents according to the FDA's requirements
- Review technical documents for clinical study permit applications. Prepare and review documents for regulatory submission to the FDA.
- Participate or lead the review of clinical study protocols and reports
- Master's degree in pharmaceutical sciences or other related scientific disciplines, Ph.D. degree will be a plus
- Working experience in the pharmaceutical or biotech industry
- Knowledge of pharmaceutical dosage forms including injectables and topicals
- Tableting, fluid bed processing and encapsulation skills will be a plus.
- Knowledge of cGMP requirements
- Able to communicate clearly and precisely in English, both in writing and speaking
- Working experience in matrixed organizations will be a plus
If interested please apply!