Director, Drug Product Design

4 weeks ago

REDMOND OR, United States Evotec Group Full time

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. ResponsibilitiesLead and grow a diverse group of scientists encompassing all aspects of biologic drug product development from pre-clinical through to commercialOptimize strategies for formulation development, stability study design and execution, and drug product manufacturing that increase efficiency and de-risk projectsLead efforts to identify, evaluate and champion new DP technologies to support the mission of low cost biotherapeutics for allCollaborate across the organization and be a key member and contributor to the Process Design Leadership TeamBe 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 planningDevelop and refine DP strategies that incorporate best practices and regulatory expectationsSupport successful DP manufacturing for client projects through external CMO’sRepresent Just at external meetings and conferences QualificationsPh.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 industryStrong 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 systemsProven 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 equipmentExcellent written and verbal communication skills, including the ability to communicate effectively over teleconference and web-based meetings are necessary.The base pay range for this position at commencement of employment is expected to be $140,000 to $201,000;  Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.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.SummaryLocation: RedmondType: Full time

  • Director, Drug Product Design

    4 weeks ago

    Redmond, United States Evotec SE Full time

    Director of Drug Product Development | Process and Product Design, Redmond WA Just-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...

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    2 days ago

    Redmond, United States Evotec SE Full time

    Director of Drug Product Development | Process and Product Design, Redmond WA Just-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...

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    1 month ago

    Redmond, United States Evotec Full time

    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...

  • Director, Drug Product Design

    2 days ago

    Redmond, United States Evotec Full time

    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...

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