Job Description
Join BioPharm Innovations, a leader in next-generation therapeutics, as we pioneer breakthrough treatments in oncology and rare diseases. Our Cambridge-based R&D hub combines cutting-edge biotechnology with rigorous clinical validation to transform patient outcomes. This pivotal role offers the opportunity to shape drug development from discovery to commercialization while collaborating with world-class scientists and industry pioneers.
Responsibilities
- Lead cross-functional teams in designing and executing preclinical studies for novel therapeutics
- Develop and optimize analytical methodologies for compound characterization and stability testing
- Ensure compliance with FDA/EMA regulations and GMP standards throughout development lifecycle
- Present research findings to regulatory agencies and contribute to IND/CTA submissions
- Mentor junior scientists and drive innovation in analytical technologies
- Collaborate with CMC teams to scale manufacturing processes from lab to commercial production
Qualifications
- PhD in Pharmaceutical Sciences, Chemistry, or related field with 5+ years industry experience
- Expertise in HPLC, LC-MS, and spectroscopic analytical techniques
- Proven track record in regulatory filings (IND/BLA) and CMC documentation
- Strong understanding of ICH guidelines and global regulatory frameworks
- Experience with biologics formulation and process optimization
- Demonstrated leadership in cross-functional project teams
- Publications in peer-reviewed journals and conference presentations