Director, Drug Product Design | Redmond, WA

Just is looking for a Director of Drug Product Design to join a fast-paced, collaborative, and multidisciplinary team to lead the drug product formulation and manufacturing team at our J.POD facility in Redmond, WA.  The position requires strong management and leadership skills, knowledge of  sterile drug product manufacturing, and a deep understanding of formulation development of therapeutic proteins from FIH through commercialization.  A proven track record of technical skills in these areas, experience working with CMO’s, as well as experience leading scientific personnel at all skill levels is required. 

Responsibilities:

  • Lead a team encompassing all aspects of formulation development for internal and external clients  from FIH through commercialization
  • Represent Drug Product department on cross-functional teams to execute on organizational goals
  • Assign resources for formulation development and DP production on project teams ensuring a successful partner/client interface
  • Technical expert on DP production in cGMP manufacturing facilities
  • Ensure successful DP manufacturing through strategic partnerships with external CMO’s
  • Provide technical management of external DP CMO’s.
  • Provide technical expertise to internal and external teams regarding glass and plastic vials, stoppers, and pre-filled syringes for designing drug product
  • Optimize development strategies that increase efficiency and de-risk FIH and commercial formulations
  • Collaborate with partner groups across the Just organization including Analytical, Bioassay, QC and QA and Manufacturing to ensure product quality and product stability
  • Independently manage staff, capital resources, and planning
  • Develop and refine worldwide regulatory communication both written and face-to-face
  • Be a technical resource for formulation development of novel compounds
  • Act as an internal technical resource for Quality, Manufacturing and Process Design, as well as a resource and subject matter expert for external clients and collaborators
  • Represent Just at external meetings related to important industry wide issues related to our business

Requirements:

  • Ph.D. in engineering or biological sciences
  • Minimum 10+ years of experience in biotechnology, pharmaceutical or life science industry

Preferred Qualifications:

  • Experience with RNA, DNA and cell based product formulation and analytics is a plus
  • Recognized expert in DP manufacturing of sterile dosage forms including frozen, liquid,  and lyophyilized formulations in vials and pre-filled syringes
  • Knowledge of typical analytical techniques including UPLC, CE, biophysics, particle measurements and particle characterization a must
  • Experience writing regulatory filings including INDs and BLAs
  • Knowledge of regulatory guidance from the FDA and EMA for development of biologic drug products and biosimilars
  • Knowledge of USP and Ph. EUR. as it relates to biologics development
  • Demonstrated managerial skills of a diverse set of scientists at all skill levels
  • Strong written and verbal communication skills, including the ability to communicate effectively over teleconference and web-based meetings are essential. 

About Just – Evotec Biologics

Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just’s focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle’s South Lake Union neighborhood – the center of Seattle’s medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 200 employees is expanding Just’s innovative platform and footprint – building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers

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