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

at  ProtaGene GmbH

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

Please refer the Job description for details