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Senior Director, Quality Control

Company: Evotec WD
Location: Redmond
Posted on: January 12, 2022

Job Description:

Just-Evotec Biologics is seeking a highly motivated Senior Director of Quality Control to join a fast-paced, collaborative, and multidisciplinary team to lead all aspects of Quality Control for the advancement of low-cost biotherapeutics manufacturing. The primary focus of this job is to lead and guide the Quality Control functions supporting both Just-Evotec's Biologics Manufacturing state of the art J.POD Facility, located in Redmond WA, as well as the J.Plant Clinical Production Facility, located in in the South Lake Union neighborhood in Seattle, WA. This highly qualified candidate will partner with Quality Assurance, Manufacturing Operations, Technical Operations, Materials Management, F&E, Process Development and EH&S functions to ensure GMP and regulatory compliance. The position requires strong management and leadership skills as well as a deep understanding of biologics analytical GMP testing of clinical and commercial drug substance and drug product biological products, GMP raw materials inspection and release, and facility environmental monitoring programs. A proven track record of technical skills in these areas, as well as experience leading groups of QC scientists is required. Strong written and verbal communication skills, including the ability to communicate effectively over teleconference and web-based meetings are necessary. The successful candidate will also proactively provide collaborative support to the internal stakeholders and have excellent customer-service orientation with a high degree of professionalism. Educational Requirements:

  • PhD degree in relative scientific discipline with 15+ years of industry experience; MS or BS degree with extensive industry experience Responsibilities:
    • Ensure success of Quality Control functions through strategic and day-to-day leadership
    • Develop and maintain strategic plan, including outsourced activities and business continuity, to ensure cGMP testing needs are met
    • Responsible for method transfers and analytical method validations for phase I through commercial testing and ensuring QC data integrity
    • Responsible for QC audit and inspection readiness, including support and preparation of responses to observations and ensuring response CAPAs are effective
    • Identify gaps, design collaborative solutions and provide guidance for laboratory efficiencies and improvements
    • Planning, coordination, and continuous improvement of methods, processes, and systems to assure the quality of testing.
    • Provide input and change management for quality improvements affecting QC methods and processes.
    • Development and implementation of testing-related Quality Management System processes. Create, maintain, and revise QC SOPs and strategy documents that support the Quality Management System.
    • Establish clear expectations, develop metrics and key performance indicators to monitor performance and ongoing activities; includes meeting and exceeding internal stakeholder and customer expectations.
    • Hire, build and maintains expertise in the QC organization, through development of staff to ensure that the QC organization supports manufacturing operations and analytical development activities as required.
    • Provide technical expertise during laboratory investigations such as CAPA, OOS and OOT.
    • Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT and team milestones are achieved Requirements:
      • Minimum of 15 years of experience in the pharmaceutical industry with experience leading a Quality Control function, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with at least 5 years in a GMP QC release testing role
      • Oversee hiring; provide coaching, guidance, and career development for highly motivated and very competent QC team
      • Thorough understanding of phase appropriate global cGMP regulations for release and stability testing of biological products
      • Regulatory inspection and commercial product launch experience
      • The candidate should have the ability to work with limited direction to follow through with specific tasks.
      • 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)
      • Extensive understanding of biologics manufacturing processes
      • Excellent technical writing, collaboration and verbal communication skills.
      • Experience with the operation, deployment, and administration of laboratory information management systems (LIMS)
      • Proficiency with Microsoft Office applications (Word, Excel and PowerPoint) Preferred Qualifications:
        • Knowledge of Waters Empower, Sciex 32 Karat and ?? Thermo Scientific Chromeleon
        • Experience with Waters HPLC, UPLC and Beckman PA800 CE systems
        • Experience with ELISA based impurity and/or potency methods Evotec 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 4,000 highly qualified people at 14 sites, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics. For additional information please go to www.evotec.com and follow us on Twitter @Evotec and LinkedIn . Please click on the link below to access and review our Privacy Information for Applicants:

Keywords: Evotec WD, Redmond , Senior Director, Quality Control, Executive , Redmond, Washington

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