Director of Biologics required to work at a fantastic world-leading CRO partner who support the Biopharmaceutical and Cell and Gene Therapy industries. Their combined protein and gene-based analytical platforms make them the leading analytic service provider across the biopharmaceutical and cell and gene therapy development spaces. They have multiple sites across Germany and this Director of Biologics will be on a hybrid pattern at one of their sites in the Baden-Wurttemberg region. This role will involve leading a team of up to 20 in size.
The Director of Biologics is available on a permanent basis and on offer is a competitive salary and package.
The key responsibilities for the Director of Biologics include:
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
The required background includes:
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