Job Description
Are you ready to pioneer the next generation of life-saving therapeutics? AstraVax Therapeutics is seeking a visionary Lead Formulation Scientist to join our high-performing R&D team in Cambridge, MA. In this role, you will be at the forefront of pharmaceutical innovation, driving the design, development, and optimization of novel drug delivery systems from early concept to clinical-phase execution.
We offer a highly collaborative environment equipped with state-of-the-art laboratory infrastructure, competitive compensation, and a comprehensive benefits package designed to support your professional growth and personal well-being.
Responsibilities
- Lead the design, development, and optimization of novel drug delivery formulations (including small molecules, biologics, and LNPs).
- Manage formulation development projects from pre-clinical phase through IND/NDA-enabling studies.
- Collaborate cross-functionally with Analytical Development, Quality Assurance, and Regulatory Affairs to ensure project alignment.
- Oversee technology transfer activities to clinical manufacturing facilities and contract development and manufacturing organizations (CDMOs).
- Author and review high-quality technical reports, regulatory dossiers (IND/IMPD), and patent applications.
- Mentor and coach junior formulation scientists and laboratory associates on best practices and scientific methodologies.
Qualifications
- Ph.D. in Pharmaceutics, Chemical Engineering, Chemistry, or a closely related discipline with 5+ years of pharmaceutical industry experience (or MS with 8+ years).
- Proven expertise in developing lipid nanoparticle (LNP) formulations, liposomes, or advanced solid oral dosage forms.
- Deep understanding of GMP regulations, FDA/ICH guidelines, and Quality by Design (QbD) principles.
- Hands-on experience with analytical characterization tools including HPLC, DLS, DSC, and XRD.
- Excellent communication skills and a track record of successfully managing CRO/CDMO partnerships.
- Strong analytical problem-solving capabilities and ability to thrive in a fast-paced, matrixed biotech environment.