Our client is a rapidly expanding vaccine company of nearly 150 people located in the heart of Kendall Square, Cambridge. They are seeking an experienced Drug Product Process Development SME to work closely with the Executive Director and the Formulation Development team to develop a novel formulation and drug product process development program to support their novel technology.
The main function of this role is to design and implement scalable strategies for drug product fill/finish for clinical and commercial programs.
Responsibilities include but are not limited to;
• Support pre-formulation and formulation development and perform process development using design-of-experiments methodology
• Evaluate critical process parameters including mixing, settling rate, and shearing forces for suspension formulations
• Work closely with Analytical Development and Process Development to present data packages at cross-functional team meetings
• Provide technical leadership to CMO and manufacturing
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have a Ph.D. in a relevant discipline and 7-10+ years of vaccine drug product process development experience. BS/MS candidates with with 10-15+ years of experience will also be considered.
Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area or able to relocate with very limited assistance.
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.