Job Description
Join BioNova Therapeutics at the forefront of pharmaceutical innovation as a Senior Pharmaceutical Scientist. We're revolutionizing drug delivery systems for chronic conditions and seeking visionary scientists to lead groundbreaking research initiatives. In this pivotal role, you'll drive the development of novel therapeutics while mentoring cross-functional teams through clinical trials to FDA approval.
Our state-of-the-art Boston facility offers unparalleled resources for translational research, including ISO-certified labs and partnerships with Harvard Medical Center. You'll collaborate with industry leaders to accelerate therapies that impact millions of lives while enjoying competitive benefits and professional development opportunities.
Responsibilities
- Lead design and execution of preclinical drug development studies for novel formulations
- Oversee regulatory compliance (FDA/ICH guidelines) for IND/NDAs and pharmacovigilance
- Develop and optimize analytical methods using HPLC, LC-MS, and dissolution testing
- Coordinate CMC activities with contract manufacturing organizations (CMOs)
- Mentor junior scientists and present findings at scientific conferences
- Manage project timelines and budgets for drug candidate advancement
- Stay current with emerging technologies like AI-driven drug discovery
Qualifications
- PhD in Pharmaceutical Sciences, Chemistry, or related field with 5+ years industry experience
- Expertise in formulation development for biologics and small molecules
- Proven track record in regulatory submissions and GMP/GLP compliance
- Strong proficiency in analytical instrumentation and method validation
- Certification in Regulatory Affairs (RAC) preferred
- Experience managing complex clinical trial protocols
- Publish record in peer-reviewed pharmaceutical journals
- Excellent leadership and cross-functional collaboration skills