Zum Inhalt springen

Director Biologics (Head of Quality Control-Analytics) (m/f/d)

  • Baden-Württemberg, Germany
Operations

·      

Job description

  • Lead, manage, and develop multiple laboratory teams, fostering a culture of excellence and continuous improvement
  • Report directly to senior management on all HQC and operational activities, ensuring alignment with company goals
  • Oversee protein analytical methods, including method development, release testing, and stability studies
  • Manage a diverse method portfolio including (U)HPLC-SEC, -IEX, RP-HPLC, LC/MS, amino acid analysis, and analytical ultracentrifugation
  • Supervise all quality control systems, ensuring compliance with GMP, ICH and AMWHV regulations and functioning as the Head of Quality Control
  • Ensure the release of laboratory results, including overseeing method transfers and co-validations according to ICH guidelines
  • Ensure the writing, review, and approval of GMP documents, including SOPs, plans, reports, deviations, changes, OOS, etc.
  • Maintain strict adherence to regulatory guidelines, supporting quality audits and inspections
  • Support the development and optimization of biologic methods, utilizing Design of Experiment (DOE) and other advanced methodologies to determine identity and purity
  • Drive the implementation of new technologies and automation in QC processes to enhance efficiency and accuracy
  • Oversee the efficient and economic management of the laboratory, optimizing processes to meet project timelines and customers’ expectations
  • Participate in personnel and budget planning, ensuring resources are effectively allocated
  • Work closely with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to meet project objectives and ensure timely delivery of analytical reports

Job requirements

  • PhD or master’s degree in Biochemistry, Molecular Biology, Biotechnology, or a related field
  • A minimum of 4 years of experience in Quality Control within the (bio)pharmaceutical industry in a GMP environment, with at least 2 years in a leadership role
  • Experience with an extensive portfolio of protein and peptide analytical techniques, including (U)HPLC-SEC, -IEX, RP-HPLC, LC/MS, amino acid analysis, and analytical ultracentrifugation
  • Extensive knowledge of biologics manufacturing, analytical techniques, and regulatory requirements (GMP, FDA, EMA, etc.)
  • Proven experience in managing and developing high-performing QC teams
  • Strong analytical and problem-solving skills, with a track record of successful investigations and CAPA implementation
  • Excellent communication and interpersonal skills, with the ability to influence and collaborate across all levels of the organization
  • Experience with QC laboratory management, including equipment qualification and method validation
  • Proficiency in data analysis software and Laboratory Information Management Systems (LIMS)
  • Strong organizational skills with the ability to manage multiple projects and priorities in a fast-paced environment
  • Economic thinking and experience in dealing with laboratory key figures


We offer

  • Responsible and varied tasks in a motivating working environment
  • A permanent position in a dynamically growing international life science group with over 200 employees
  • Optimal induction and training opportunities as well as individual development options
  • Appreciation, openness and respect as well as a lively feedback culture
  • Flat hierarchies, short decision-making processes and flexibility
  • Comprehensive health management
  • Job-Bike leasing
  • Regular company and team events
  • Heilbronn, Baden-Württemberg, Germany
Operations

or

Apply with Indeed unavailable
  • Heilbronn, Baden-Württemberg, Germany
Operations