Germany
Heading a group of lab heads, scientists, technicians and supporting staff Responsible for the development of state of the art and innovative analytical methods Analytical support for process development, product characterization as well comparability studies for biopharmaceutical products Previous activities: CMC Project leader , Lab Head QC .
Leading and developing a team of scientists and technicians, fostering strong collaboration and scientific excellence. Overseeing analytical strategy and ensuring high‑quality deliverables across potency assays, mass spectrometry, and spectroscopy. Owning portfolio execution with responsibility for timelines, quality, and resource alignment. Managing budget and headcount while driving efficient laboratory and project operations. Building strong cross‑functional partnerships within CMC to support our NBE & NCE pipeline.
Leads one Pharmaceutical Development Biological group, responsible for formulation design, process development, in-use stability, and primary packaging of parenteral dosage forms for early and late-stage development up to launch site implementation Oversees execution of all Drug Product development work packages, including preparation for BLA submissions Contributes to the design, implementation, and continuous improvement of Drug Product strategies to ensure optimal product quality, cost-efficiency, and lean resource utilization Mentors and guides formulation scientists to foster continuous learning, harmonize development approaches, and uphold quality standards in daily operations Ensures compliance with relevant regulatory, legal, and internal requirements for global product development and submissions Applies in-depth knowledge of GMP regulations, SOPs, guidelines, and business practices (e.g., pharmacopoeial standards, Drug Product Development Guideline, Process Validation)
Provides technical and managerial leadership for the Analytical Project Labs within Analytical Development Biologicals Acts as Head of Quality Control (LQK) in accordance with §12 AMWHV for assigned biopharmaceutical development projects Ensures scientific expertise and strategic support across all New Biological Entity projects Maintains strong collaborative relationships with internal interfaces and external stakeholders Serves as key contact for outsourcing activities and analytical strategy with CROs for assigned NBE projects Responsible for the analytical control strategy, including phase-appropriate development, validation, and routine testing of the full analytical method panel Supports characterization studies, drug substance and drug product release, and stability testing for toxicological and clinical supplies Provides state-of-the-art analytical methods and scientific conclusions to support all functions within Development Leads strategy development, execution, and evaluation of analytical comparability assessments for biopharmaceutical products Delivers high-quality submission documents for clinical trial applications and biological license applications
Planning and coordinating of all activities throughout different departments. Leading of the interdisciplinary project team Reponsible for time and budget issues, as well as project implementation. File status and progress reports at pre-determined intervals and organize meetings and phone conferences. Experienced with orphan drug projects
Technical and disciplinary superior of a 10-persons-team within the quality control Responsible for development and validation of immunoassay-based methods (Biacore, ELISA, DNA-threshold, Gyros etc.) Assay performance in GxP environment Deputy of Head of quality control biology (25 people staff)
Development of poly- and monoclonal antibodies against the algal toxin domoic acid (Ph.D work)