Principal Scientist, Formulation Development

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 expertise and leadership in drug product development and formulation activities in order to support clinical studies in different phases. This role is expected to conduct both in-house formulation development activities and manage CMOs for formulation development and drug product manufacturing. 

Responsibilities include but are not limited to;
•  Search/evaluate/develop drug product formulation/manufacturing technologies to support program needs 
•  Conduct drug product formulation and manufacturing process development activities at in-house laboratory in collaboration with internal development team
•  Lead drug product development activities and serve as representative in CMC team and potentially serve as CMC lead in program team 
•  Manage manufacturing activities such as monitoring production campaigns, batch record review, and analytical data evaluation 
•  Author and review CMC sections for regulatory submissions
•  Support any quality investigations or events as needed

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;
•  Development and GMP manufacturing for NCE, either with internal manufacturing team or managing outsourced manufacturing at CMO partners  
•  Solid oral dosage formulation development, especially on solubility enhancing formulations, and/or controlled release formulations
•  Solid oral dosage technologies such as fluid bed coating/granulation, spray drying, hot melt extrusion, wet & dry granulation, milling, tablet compression/coating, and encapsulation
•  Familiarity with common analytical techniques required to support product development (HPLC, DSC, TGA, XRPD, IR/Raman spectroscopy, particle size analysis)

Ideal candidates will have experience on authoring regulatory filing documents (CTD Module 3) for major regulated markets (US, EU, etc.)

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.