We are seeking a Principal Scientist, Clinical Process Development to lead the advancement of assigned assets from pre-clinical through commercial phases, including internal process or product development experimentation and collaboration with external partners for development and manufacturing.
Requirements
- BS/BA in pharmacy, pharmaceutical sciences, chemistry, biochemistry, biology, or similar scientific discipline and 8+ years of experience in formulation research, clinical research, experience managing laboratory, maximizing productivity is desirable
- MS/MA in pharmacy, chemistry, biochemistry, biology, or similar scientific discipline and 6+ years of similar experience
- PharmD or PhD in Pharmaceutical Sciences or similar scientific discipline and 4+ years of relevant experience
- Experience supporting clinical trials, especially in-use/actual-use studies
- Familiarity with clinical protocol development, amendments, and clinical study reports
- Good understanding of GCP, GLP, and relevant FDA/ICH guidance
- Experience working in a regulated environment
- Excellent laboratory and productivity skills
- Experience working with CROs, clinical sites, investigators, and external vendors is a plus
- Demonstration of cross-functional understanding related to drug development
- Advanced knowledge and demonstrated ability to work with / recommend a variety of laboratory equipment/tools
- Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas
- Develops and drives creative solutions to technical challenges
- May develop an understanding of other areas and related dependencies
- Ability to work as part of and lead multiple teams
- Exhibits leadership skills, typically leads junior levels and/or indirect teams
- Excellent interpersonal communications, problem-solving, and analytical thinking skills
- See broader picture, impact on multiple programs, teams and/or departments
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
- Excellent project management skills
Benefits
- Retirement savings plan (with company match)
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits to include medical, prescription drug, dental and vision coverage
