Director Biologics (Head of Quality Control-Analytics) (m/f/d)
ProtaGene GmbH Dortmund
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
- Ph D 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
- 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
- - Dortmund, Nordrhein-Westfalen, Germany
- Operations
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