Kathy Hasenbach
Senior Project Leader @Formycon AG
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WORK HISTORY
Senior Project Leader @Formycon AG
Munich, DE
Leading cross-functional CMC project teams in the development of biosimilars/monoclonal antibodies, including key interfaces with Analytics, Drug Substance, Drug Product, Regulatory Affairs, QA, and Device Development.• Currently leading the integration of PFS into autoinjector platforms, expanding scope into drug-device combination products and medical device development.• Collaborating closely with internal device experts, external device partners, and regulatory teams to align on combination product strategy and documentation.• Oversaw the development of vial and prefilled syringe (PFS) presentations for antibody-based biosimilars.• Managed submission planning and content coordination across departments for regulatory dossiers.• Responsible for project budgets, resource planning, and timeline tracking across entire development programs.• Conducting scenario analysis, risk assessments, and mitigation strategies to support robust project execution.• Lead and facilitate internal and external project meetings with global stakeholders and external partners (e.g, CMOs, CROs, device vendors).
EDUCATION
Gesamtschule Kierspe
Allgemeine Hochschulreife
University of Zurich
Dr. sc. nat., Biologie, allgemein
University of Cologne
Dipl. Biol., Biologie, allgemein
SKILLS
ABOUT KATHY HASENBACH
Versatile, proactive, and results-oriented project leader with deep expertise (+10 years) in CMC development, biosimilars, and drug-device combination products. Skilled in managing complex cross-functional teams and external stakeholders across all phases of product development—from early-stage formulation to device integration.Demonstrated success in managing biologic product development across multiple dosage forms, including vials and prefilled syringes (PFS), with current focus on integrating PFS into autoinjector platforms. Combines deep knowledge of biologics with hands-on experience in drug-device combination products, working across both internal development functions and external partners (CDMOs, CROs, device vendors).Strong track record of delivering technical and regulatory milestones across all stages of development, from early-phase strategy to submission planning. Skilled in risk management, budget/resource planning, vendor oversight, and aligning cross-disciplinary teams within matrix organizations.
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