Our client is a mid-sized, public, therapeutics company in Cambridge and they are growing! Reporting to the Senior Director of Technical Services, this will be an integral part of the development and manufacturing team. This is a urgent and critical hire as the company prepares for commercialization of their 2nd product.
The main function of this role is to develop stable and bioavailable formulations for clinical and commercial use by providing technical support for drug product development, process validation, and tech transfer activities.
Responsibilities include but are not limited to;
• Conducting optimization and process scale up studies and statistical analysis of experimental data.
• Generate data for project progression and regulatory filings.
• Oversight of the manufacturing process at CMOs with a focus on process improvements and resolution of critical manufacturing issues.
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have BS degree or higher and 10-15+ years of relevant industry experience in formulation development, GMP drug product manufacturing, validation, release testing, and characterization. Preference for those with direct experience working with CMOs and experience working with small molecule new chemical entities (NCEs) in a range of dosage forms.
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. Must be able to travel to DP manufacturing site(s) for on-site support (domestic or international).
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.