- 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
- 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.
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Director, Drug Product Design - Redmond, United States - Evotec
Description
Director of Drug Product Development | Process and Product Design, Redmond WAJust-Evotec Biologics is looking for a Director of Drug Product Development to join a fast-paced, collaborative, and multidisciplinary team to lead all aspects of drug product development for the advancement of low-cost biotherapeutics manufacturing. The Director is responsible for strategic oversight and leadership of the full scope of drug product activities for novel biologics and biosimilars from pre-clinical through commercialization. This role requires a strong technical background in biologic drug formulation, process development, manufacturing and drug delivery. A proven track record of technical skills in this area, experience leading groups of scientists, experience with early and late stage regulatory filings and regulatory interactions, and experience working effectively with third-party DP CMOs is essential. Familiarity with analytical characterization and a working knowledge of CMC manufacturing is required.
Responsibilities
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
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