Director Biologics (Head of Quality Control-Analytics) (m/f/d)
Director Biologics (Head of Quality Control-Analytics) (m/f/d)
ProtaGene
Heilbronn, Germany
ProtaGene is a world-leading analytic CRO partner for the biopharmaceutical and gene and cell therapy industry. From research through product commercialization, we provide the most advanced, integrated, and quality system driven analytic capabilities and packages for biologic therapeutics as well as gene and cell therapy platforms. Our deep history of analytical leadership in protein-based therapeutics stems from the merger of Protagen Protein Services in Europe and BioAnalytix in the US.
In 2021 GeneWerk’s unique capabilities in vector safety, integration site analysis, and bioinformatics were integrated into our platforms and service offerings, establishing ProtaGene. The organization operates over four sites in Europe and North America, and works with leading large pharma, biopharmaceutical, and gene therapy companies worldwide.
Responsibilties:
- 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)HPLCSEC, -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.
How to apply:
If you are interested in this position, kindly submit your application documents including a letter of motivation online via the Apply Now button.
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