Nicole Biebel
@nicolebiebel
I prepare GMP-compliant CMC release documentation for global pharmaceutical development projects.
GermanyWhat I'm looking for
At Boehringer Ingelheim Pharma, I plan, coordinate, and compile CMC release documentation for global NCE development projects under EU GMP and US 21 CFR 210/211. I bring together QC, analytical, and regulatory inputs to deliver inspection-ready dossiers on time.
I combine release-file and GMP close-out work with hands-on molecular and cellular laboratory experience, including PCR, ELISA, flow cytometry, protein characterization, HPLC, and mass spectrometry. I also improve templates and workflows to make documentation more consistent and efficient.
Experience
Work history, roles, and key accomplishments
Specialist Release File Preparation
Ferchau GmbH
Apr 2023 - Present (3 years 5 months)
Planned, coordinated and compiled CMC release documentation for global development NCE projects in compliance with EU GMP and US 21 CFR 210/211. Coordinated inputs from QC, analytical and regulatory teams to assemble inspection-ready dossiers and meet project milestones and submission deadlines.
Masterthesis
Ulm University Hospital
Feb 2022 - Jul 2022 (5 months)
Conducted research at the Institute of Clinical and Experimental Immunology, focusing on immunology and experimental methods.
Management of the family-owned restaurant
Pizzeria La Nico
Aug 2009 - Feb 2022 (12 years 6 months)
Managed the family-owned restaurant, overseeing daily operations and ensuring customer satisfaction.
Control and inspection of lithium-ion accumulators
Varta Microproduction
May 2020 - Aug 2020 (3 months)
Performed control and inspection of lithium-ion accumulators, including inventory bookings with SAP.
Sterilization and preparation of cytotoxic agents
Sterile laboratory Ries Pharmacy
Jul 2017 - Sep 2017 (2 months)
Performed sterilization and preparation of cytotoxic agents for chemotherapy, including sampling, analysis, and control of microbes in sterile rooms.
Telephone Operator
Concept and Service
Jul 2016 - Sep 2016 (2 months)
Worked as a telephone operator, handling incoming calls and providing customer service.
Education
Degrees, certifications, and relevant coursework
University of Salzburg
Master of Science, Life Sciences
2020 - 2023
Master of Science with a thesis on adipokines modulating immune response after trauma.
University of Salzburg
Bachelor of Science, Life Sciences
2016 - 2020
Bachelor of Science with a thesis on Next Generation Sequencing.
University of Tuebingen
2014 - 2016
Attended the University of Tuebingen from 2014 to 2016.
Benedikt-Maria-Werkmeistergymnasium
Completed secondary education at Benedikt-Maria-Werkmeistergymnasium in 2014.
Availability
Location
GermanyAuthorized to work in
Salary expectations
Job categories
Skills
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