What are the responsibilities and job description for the Sr Director Drug Product Development position at Precision Life Sciences?
Job Description : Director / Senior Director, Drug Product Development
This individual will serve as an integral team member with exposure to multiple facets of business operations. The Director / Senior Director, Drug Product Development will lead drug product formulation and filling process development as well as cGMP manufacturing at Client company’s CDMOs. Additional features of the position include responsibility to lead process scale up and characterization studies required to support drug product and formulation development life-cycle management.
Client company is a growing organization based out of the Seaport area of Boston, Massachusetts with additional staff functioning in a virtual based environment from the Greater Boston area and throughout the United States. This position allows for hybrid work with ~2-3 days / week requiring onsite attendance.
Major Duties / Responsibilities
- Lead drug product formulation and formulation process development, as well as cGMP manufacturing at CDMOs.
- Lead process scale up and characterization studies required to support drug product and formulation development life-cycle management.
- Perform risk assessments / FMEAs through process development to process validation.
- Lead internal and external formulation development for injectable drug products and ultimate technical transfer(s), as applicable, of the manufacturing process to commercial manufacturing site(s).
- Partner with key stakeholders and work collaboratively with cross-functional CMC, quality, regulatory, project management, legal, supply chain, and other functions to meet company goals.
- Author applicable drug product sections in regulatory submission documents and support global filings.
- Author technical reports and applicable sections of clinical pharmacy manual(s).
- Establish applicable technical procedures and business process flows to support drug product life-cycle management.
Education & Professional Experience Required :
Working Conditions
Busy office / laboratory environment with frequent deadlines and interruptions.
Travel
Travel is minimal (10-20%).
Physical Requirements
Subject to periods of sitting or standing, vision is required to monitor data.
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