Antares Therapeutics · 1 day ago
Principal Scientist, Formulation Development (Small Molecules)
Boston, MA
Full-time
Hybrid
Lead/Staff
$160K/yr - $220K/yr
8+ years expAntaresRX is seeking a Principal Scientist in Formulation Development to lead the design and optimization of drug product formulations. This role involves significant hands-on experimental work and cross-functional collaboration to support the advancement of novel programs.
BiotechnologyLegalHealthcarePharmaceuticalManufacturingLife ScienceBiopharmaEdiscoveryHealth CareTherapeutics
Responsibilities
Develop and implement formulation strategies for small molecules, ensuring alignment with Quality Target Product Profile (QTPP) and CMC objectives
Utilize advanced in-house and external technologies (e.g., solid dispersions, co-crystals) to enhance solubility, stability, and manufacturability
Oversee scale-up activities, CTC profiling, dissolution studies and packaging configurations. Directly manage technology transfer to external partners
Design and interpret stability studies using ICH and ASAP techniques. Implementation of robust in-process controls and product performance
Partner with Analytical Development, Chemical Development, Regulatory Affairs, and Quality to deliver integrated CMC solutions
Prepare technical reports, protocols, internal updates and regulatory submissions in compliance with internal policies and global regulations
Champion opportunities to introduce enabling technologies for process improvements and develop best practices
Qualification
Required
PhD in Pharmaceutical Sciences, or a related field with 8+ years of experience in formulation development or M.S. with 12+ years
Proven track record in developing oral solid dosage forms and supporting IND/NDA submissions
Expertise in pre-formulation, manufacture and advanced delivery technologies
Strong knowledge of regulatory guidelines (ICH, FDA) and GMP principles
Excellent leadership, communication, and technical writing
Preferred
Knowledge and experience in developing amorphous dispersions is an advantage
Company
Antares Therapeutics
Antares is a biotechnology company focused on developing transformational,medicines targeting validated cancer and other serious diseases.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$177MKey Investors
Atlas Venture,Biotechnology Value Fund,Cormorant Asset Management,Lightspeed Venture Partners,Omega Funds
2025-05-15Series A· $177M
Leadership Team
Amanda Valentino
Chief People & Culture Officer
Company data provided by crunchbase