Jana Majerská

- QC analytical scientist supporting analytical release and stability testing for commercial biologics products (DS and DP). - QC analytical oversight support of 4 CMOs, 5 CTLs, and 2 packaging sites: analytical data review, sample & document management, analytical release, stability program support, vendor qualification, collaboration to method transfers, method improvement, and/or method validation/verification. - A lead and/or SME for investigations, CAPAs, and change controls.

Responsibilities: facilitate effective cross-functional communication and translate documents between English and Slovak/Czech - ISO standards, SOPs, QA, instrument calibration & validation.

Planning and execution of laboratory and project-based activities in support to CMC and Nonclinical Pharmacology. Development & qualification of binding and potency assays to characterize the in vitro bioactivity of therapeutic antibodies at different stages of development (Biacore SPR, ELISA, FACS, cell-based functional assays). Data generation for QTPP establishment, regulatory CMC and non-clinical packages. Authoring SOPs, study protocols and reports.

Development, optimization and pre-validation of ELISA and cell-based functional assays for therapeutic antibodies. Ensure alignment with regulatory requirements (FDA, ICH, US/EU Pharmacopoeias). Draft and review SOPs, development reports, and other technical documents. Facilitate method transfer.

Swiss Institute for Experimental Cancer Research - Laboratory of Prof. Joachim Lingner - PROJECTS: Telomeric chromatin in cancer development (ChIP-MS proteomics screens; hit characterization and validation; structure-function studies of nucleoprotein complexes; telomeric repeat-containing RNAs; DNA:RNA hybrids). The role of homology-directed DNA repair factors at telomeres (RNAi phenotypic screening). - RESPONSIBILITIES: research in the fields of telomere and cancer biology and DNA damage response & repair pathways; definition of testable hypotheses and experimental strategy, design and execution of complex cell/molecular biology and biochemistry experiments; assay development and optimisation; troubleshooting; data analysis and interpretation; diligent record keeping; scientific writing; project presentation in different settings and venues; laboratory operations support; student supervision and teaching; technical lead and training of junior staff; establishment and management of collaborations. - Marie Curie Fellowship, 2013-2016 (CodeAge - FP7 Marie Curie Initial Training Network)

Chromatin Molecular Complexes Group - Laboratory of Prof. Jiří Fajkus - PROJECTS: Functional characterization of plant telomerase; study of telomerase oligomerization, interdomain and protein-protein interactions. - RESPONSIBILITIES: experimental design, execution, and data analysis under minimal supervision; strategic planning and reporting; collaboration with external laboratories to source expertise and reagents; multitasking among multiple projects; oral and written presentation of experimental results; supervision of junior team members; laboratory operations support.

Swiss Institute for Experimental Cancer Research - Laboratory of Prof. Joachim Lingner - PROJECT: Characterization of CTC1 mutations found in patients with Coats Plus and Dyskeratosis Congenita syndromes. - RESPONSIBILITIES: work independently and in close collaboration with Dr. Liuh-Yow Chen to generate robust data for publication under tight time constraints; employ gain of function and loss of function techniques to dissect the mechanistic basis of disease associated mutations and pathways; contribute to assay development.