Our client is a mid-sized, small-molecule therapeutics company that went public last year and is planning for commercialization and development of their pipeline assets. They are located in brand new offices and labs across from the T in the Kendall Square/East Cambridge area.
The main function of this role is to provide technical leadership and expertise in drug product development and formulation activities of small molecules post-proof of concept through long-term commercial support. You also get to mentor, train, and recruit members of the CMC team!
Responsibilities include but are not limited to;
• Identify and manage external partners for late-phase development through long-term commercial manufacturing while driving pharmaceutical development of late-stage program portfolio
• Manage manufacturing activities including monitoring production campaigns (some travel necessary), reviewing of batch records, and process analytical batch data
• Support quality investigations or events as needed
• Author and review CMC sections for regulatory submissions
• Serve as a technical driver for late-stage development programs and lead tech transfer and validation activities across several projects
• Assess and support drug product characterization and shelf-life setting
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have a PhD and 6+ years of experience post-PhD (post-doc experience included) in the development and/or commercialization of small molecule, solid oral dosage formulations. Candidates with a BS/MS and 12-15+ years of experience are also eligible.
Must have experience in the following;
• Subject matter proficiency in the development of oral formulations for late phase and commercial formulation development, characterization, and optimization
• Experience in one or more of the following: solubilization, spray drying, hot melt extrusion, nanoparticles, wet & dry granulation, milling, tablet compression/coating, and encapsulation
• Familiarity with common analytical techniques required to support product development (dissolution testing, hardness testing, HPLC, XRPD, IR/Raman spectroscopy, and particle size analysis
• Experience with managing CDMOs during late clinical-stage pharmaceutical development
Ideal candidates will have experience leading/supporting NDA efforts.
Must be authorized to work in the US currently to be considered (Visa transfers can be accommodated) and must be commutable to the Cambridge area or able to relocate with limited assistance.
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.