Director, Drug Product Design
Location
Redmond, WA | United States
Job description
About our client
Our client is a life science company with a unique business model focused on delivering highly effective new therapeutics to the patients. The Company leverages its multimodality platform, the “Data-driven R&D Autobahn to Cures”, for proprietary projects and within a network of partners including Pharma, Biotech, academics, and other healthcare stakeholders. With more than 4,500 highly qualified people at 17 sites, they aim to create the world-leading co-owned pipeline for innovative therapeutics.
Job
Responsibilities:
- Lead and grow a diverse group of scientists encompassing all aspects of biologic drug product development from pre-clinical through to commercial
- Optimize strategies for formulation development, stability study design and execution, and drug product manufacturing that increase efficiency and de-risk projects
- Lead efforts to identify, evaluate and champion new DP technologies to support the mission of low cost biotherapeutics for all
- Collaborate across the organization and be a key member and contributor to the Process Design Leadership Team
- Be a technical resource on DP for biologics and biosimilars for Discovery, Process Design, Quality, and Manufacturing, as well as a resource and subject matter expert for clients, service providers and collaborators.
- Serve as a formulation development lead and/or oversee leads on cross-functional project teams.
- Manage and develop staff, and manage capital and resource planning
- Develop and refine DP strategies that incorporate best practices and regulatory expectations
- Support successful DP manufacturing for client projects through external CMO’s
- Represent Just at external meetings and conferences
Requirements: :
- Ph.D preferred in a relevant field (e.g. biochemistry/chemistry, pharmaceutical sciences, chemical engineering) with 10+ years, MS with 7+ years of experience, or equivalent experience in the biopharmaceutical industry
- Strong expertise in formulation, DP process development and drug delivery for biologics and biosimilars including frozen, liquid and lyophilized formulations in vials, pre-filled syringes and devices.
- Experience in DP development for commercialization including risk assessments, process characterization and validation.
- Strong knowledge of regulatory guidelines and practices and experience authoring IND/IMPD/BLA/MA sections and USP/Ph.Eur.
- Experience with high throughput automation and data systems.
- Proven track record of scientific, management and leadership skills and ability to work collaboratively and flexibly in a team environment with other functions to solve problems and deliver projects.
- Experience with resource planning tools, capital planning and budgeting, and allocation and tracking of resources and equipment
- Excellent written and verbal communication skills, including the ability to communicate effectively over teleconference and web-based meetings are necessary.
Job tags
Salary