Head of Quality Control & Analytical Development
A pioneering biopharmaceutical company developing next-generation therapeutics — is seeking a Head of QC & Analytical Development to take strategic and operational ownership of all analytical and quality control activities across their German manufacturing site.
The Role
* Lead and develop multidisciplinary QC and Analytical teams (Analytical Development, Raw Material, In-Process, Release, and Stability testing)
* Oversee method development, qualification, validation, and transfer of analytical methods supporting both Drug Substance and Drug Product manufacturing
* Ensure full GMP compliance for all QC operations, including data integrity, investigations, and regulatory inspections
* Act as the key technical authority for analytical strategy, working closely with QA, Manufacturing, Regulatory Affairs, and R&D
* Drive continuous improvement initiatives and analytical lifecycle management to enhance efficiency and scientific robustness
* Represent QC in cross-functional CMC and tech transfer projects, both internally and with external partners or CMOs
Your Background
* Degree (PhD, MSc, or equivalent) in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field
* 10+ years' experience in QC and/or Analytical Development within biologics, radiopharmaceuticals, or advanced therapies
* Proven leadership experience managing QC laboratories in a GMP-regulated environment
* Strong knowledge of analytical techniques (HPLC, GC, CE, spectroscopy, bioassays) and regulatory guidelines (ICH, EMA, FDA)
* Experience in tech transfer, method validation, and regulatory submissions highly desirable
* Fluent in English & German language skills advantageous