Job Description
Join BioPharm Innovations, a leader in cutting-edge pharmaceutical research, as we pioneer the next generation of life-saving therapies. We seek a passionate Senior Pharmaceutical Scientist to drive innovation in drug development and regulatory compliance. You'll collaborate with world-class researchers in our state-of-the-art Cambridge facility, contributing to breakthrough treatments that impact global health. Enjoy competitive compensation, comprehensive benefits, and a culture that values scientific excellence and professional growth.
Responsibilities
- Lead formulation development and optimization for novel drug candidates
- Design and execute preclinical/clinical studies adhering to FDA regulations
- Prepare and submit regulatory documentation (IND/NDA) to health authorities
- Coordinate cross-functional teams across R&D, manufacturing, and quality assurance
- Implement GMP standards and ensure compliance with international guidelines
- Analyze complex pharmacokinetic and safety data to support product approvals
- Mentor junior scientists and contribute to departmental innovation initiatives
Qualifications
- PhD in Pharmacy, Pharmacology, or related field with 5+ years industry experience
- Expertise in pharmaceutical development and regulatory affairs processes
- Proven track record with FDA/EMA submissions and compliance frameworks
- Strong analytical skills with proficiency in statistical analysis software
- Deep knowledge of GMP/GLP standards and quality management systems
- Excellent written/verbal communication and leadership abilities
- Experience with biologics or small molecule drug development preferred