QC Manager  | Redmond, WA

Just-Evotec Biologics is seeking a highly motivated individual who desires a significant opportunity to improve worldwide access to biotherapeutics. The QC Manager will provide leadership in a fast paced, collaborative QC Analytical laboratory that supports GMP testing of clinical biological products. In addition to performing product testing, the Manger will oversee the DS and DP stability programs, sample management, inventory of critical reagents and manage the daily laboratory activities. The successful candidate will have extensive laboratory compliance experience, exceptional attention to detail and have experience designing and implementing laboratory efficiency improvements.

Responsibilities:

  • Oversee the daily activities of the QC Analytical laboratory in support of large molecule release and stability analysis
  • Conduct analytical testing and provide hands on training to staff
  • Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT and team milestones are achieved
  • Provide subject matter expertise during internal project team meetings and interactions with clients
  • Assist with the design and implementation of a raw materials testing program to support commercial manufacturing
  • Provide expertise for the IOPQ of laboratory instrumentation, analytical equipment troubleshooting and routine equipment maintenance
  • Author stability summary reports, product specifications, stability protocols, SOPs, guidance documents and analytical methods
  • Provide technical support during analytical method transfer into the QC laboratory
  • Identify gaps, design collaborative solutions and implement laboratory improvements
  • Oversee laboratory investigations, deviations, OOS, and CAPAs.

Requirements:

  • BS in Biochemistry, Chemistry or related field with 8-12 years of experience and a minimum of 5+ years of hands-on experience managing a cGMP compliant laboratory
  • Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA) as they relate to drug substance biological manufacturing and release / stability testing
  • Extensive knowledge of GdPs, GMPs and DS / DP multi-compendial assays (USP, EP, JP)
  • Understanding of biologics manufacturing processes
  • Demonstrated experience leading, mentoring and developing team members
  • Excellent communication and collaboration skills
  • Experience with the operation, deployment, and administration of laboratory information management systems (LIMS).
  • Proficient with Waters Empower, Sciex 32 Karat and Microsoft Office applications (Word, Excel)
  • Experience with Waters HPLC, UPLC and Beckman PA800 CE systems
  • Experience with ELISA based impurity or potency methods
  • Method validation experience
  • Attention to detail and highly organized

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 100 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

apply for this position:

please send resume and cover letter