Manager Product Development Putney
Putney is a pharmaceutical company based in Portland, ME which specializes in providing high quality generic drugs for pets where cost is a barrier to prescribing, compliance or use. Putney's current pipeline includes orals, injectables, liquids and semi-solid dosage forms. The position of Manager, Product Development provides a unique opportunity to help accelerate the development of products for a fast-growing early stage company and play a crucial role in reducing risk in outsourcing development and manufacturing activities to third parties.
The Manager will be experienced in at least one area of product development (formulation; analytical test specifications and method validation; process development; process validation; or cGMP manufacturing). The Manager will work closely with Putney?s manufacturing partners and contract manufacturers to ensure they will meet the expectations of FDA?s Center for Veterinary Medicine and meet Putney?s Product Development goals. The Manager will work closely with Regulatory Affairs in the collection and review of documentation supporting the on time filing of ANADA submissions.
The Manager will be a member of an 8-10 person Product Development and Regulatory Affairs team and will report to the Senior Director, Product Development. The Manager will be a self motivated, but strongly collaborative team player, who excels at tracking multiple, concurrent projects. The Manager will enjoy being hands-on with projects and in particular to delving in with colleagues and partners to understand and overcome the obstacles that arise in projects.
The Manager will have a MS or PhD in chemistry, analytical chemistry, pharmaceutics or similar and at least 7 years, post-graduate experience in their field.
||Portland, ME |