johana luna

* Bioinformatic analyses of data from project results. * Drafting, writing and support of patent application. * Working on establishment of networks as a basis for interaction with scientific partners and industrial customers at scientific meetings/conferences.

* Management of national and international projects dealing with all areas related to development and characterization of e.g. Biopharmaceuticals & Biosimilars (method qualifications / method validations according to GMP, GLP, GCP, GCLP & ICH Q2R1; product release testings, tech transfer, PK analytics of clinical trials) * Generation of project plans – track keeping of all project relevant activities, timelines, actions and resources * Customer relationships and communication – close interaction with counter parts (project management) at the client side * Interface management: customer <> laboratory <> middle/senior management * Close co-operation with Quality Control (QC), Quality Assurance (QA) and Assay Development (AD) department * Organization, moderation and documentation of meetings and presentations to all stakeholders (internal/external). * Improvement of internal processes and organizational belongings. * Coordination of sample income / sample logistics

* Initiation and management of projects in the Service Management field for national and international clients. * Planning and management of customer projects by using Prince2 guiding principles. * Responsible for the adherence to budget, time and quality in projects. * Creation and updating of the quality, risk and open-point registers. * Leadership and responsible of Change Request Management. * Tracking and reporting to customers, steering committee and Service Manager. * Professional Management of the team manager, consulting teams and external service providers based on defined work packages (incl. resource planning).

* Murine dissection techniques * Standard histological and immunocytochemistry techniques

* Managing and leading of gene therapy project. * Writing and reviewing of research plans, reports and documents (in English). * Creation of Standard Operating Procedures (SOP) of cell culture in English from German in compliance with the quality system. * Preparation and performance of trainings from the respective created SOPs. * Planning and performing of experimental mammalian cell culture project. * Construction of gene vectors for gene therapy. * Isolation of primary cells & ex-vivo assays * Transfection methods for mammalian cell culture.

* Reviewing and execution of research plans. * Construction of gene vectors using cytomegalovirus immediate early enhancer/promoter (CMV) promoter and the coexpression with the sulfatase modifying factor 1 (SUMF1) on GALNS activity for gene therapy on Morquio A disease.

* Managing and leading of several projects in parallel for the research group. * Primary contact person for national and international cooperation partners/clients. * Presentation of results in team meetings, advisory boards, and national and international scientific meetings/conferences. * Working on establishment of networks as a basis for interaction with scientific partners and industrial customers at scientific meetings/conferences. * Assay Development (protein microarrays) for cancer research. * Patent inventor: Colon cancer diagnostic method and means (EP20130158199) & Prostate cancer diagnostic method and means (EP3214444A1). * Creation of Standard Operating Procedures (SOP) in compliance with the quality system. * Writing and submission of grant proposals. * Bioinformatic analyses of data. * Discovery of biomarkers for early cancer diagnostics. * Students´ supervision.