Simone Kristina Nielsen Email & Phone Number

Injectable Method Development

Quality Assurance of activities carried out in the development laboratories, during development and production of new pharmaceutical products for clinical use, phase 1-3.• Approval of documentation (including change controls and deviations) in connection with development of analytical methods• Approval of analytical qualification and validation documentation in the process of release of drug substances and drug product for clinical trials• Approval of establishment protocols, reports, instructions, specification etc.• Review of CMC documentation in connection with clinical trials andregistration applications• Compliance responsible for analytical development laboratory • Equipment and IT QA responsible for analytical development laboratories• Consultant for analytical development laboratories, eg. troubleshooting for ad hoc questions and challenges within compliance of the analytical development activities• QA oversight and cooperation with analytical development laboratory to ensure compliance• Participation in R & D projects, development projects and pipeline projects• Establishment and maintenance of QA policies and overall procedures• Audit and inspection readiness.• Working with quality systems, eg. novoGLOW, A2dbweb, novoDOCS,QARD, novoLIMS viewer, ART (for QA)• Participation in many quality and lean projects• A3 champ• Training Responsible for QA department, establishing job-training-plans andensuring compliance with training in department. Working with ISOtrain,modules, curriculums and QBIQ.• Trainer for new employees• Ensuring QAP timeliness in departmentIntern courses: cLEAN Basic cLEAN 1-STAROOS InvestigationsCC and NC in novoGlOW, CMC Incident Training/ NC Challenge, GMP requirements (module 1-6), Improving Process QualityRegulatory requirements for different submission types and the related approval processesExtern courses:IT compliance, Data Integrity Workshop/ DUBLIN

I developed a sample preparation which coupled with LC-MS, was able to quantify Glucagon-Like-Peptide-1 in low picomolar range and which enabled detection of major metabolites in same analytical run. The method was furthermore validated according to different protocols from FDA and EMEA with the final result of a valid method.Grade: 12 (A)During the development phase I constantly optimized a range of parameters. In addition, I gained experience with:• Glucagon-Like-Peptide-1 in complex matrices• Sample preparations using new approaches• Antibodies and antibody conjugation • A range of anti adsorption agents• Stability experiments• HPLC analysis• Large amounts of data• Knowledge of GxP, in particular I gained insight in GMP and GLP• A range of SOPs.Programmes: Xcalibur, Gpmaw, GraphPad Prism, StatView, Excel

• Reading relevant scientific articles• Assigning keywords to articles• Updated on LEO Pharma’s products• Updated on the newest development within each product• Updated on clinical trials, animal experiments, metaanalysis, in vitro experiments ect.• Training of new employee • Conducting a manual for new employees

• Creation of administrative regulatory documents• Contacting embassies around the world in connection with registration of products• Responsible for handling old variations• Managing documentation and correspondence for new variations and renewals • Assisting in preparation of drafts and final documents for scientific meetings• Assisting in preparation of News Letters that contained latest up-dates concerning LEO Pharma• Compilation of documents ready for submission• Updating and uploading files in databases• Managing several tasks with tight deadlines• Conformity of LEAN principles • Adhoc student tasks.

Title of project : 'Influence of n-3 PUFA analogues on MDA-MB 231 cancer cell proliferation and migration'. Grade: 12 (A)I worked full time as a graduate scientific research student at the lab of professor M. Murray at the University of Sydney, Australia. I investigated the mode of action of a group of novel anticancer agents in breast cancer cells. I gained insight in a range of in-vitro techniques and the project involved:• mammalian cell culture• cell cycle kinetics • RNA extractions• real time RT-PCR • relevant functional assays such as cell proliferation and apoptosis.Programmes: StatView, GraphPad Prism, Reference Manager, Excel

• Counseling in medicine and adverse effects to patients• Insight in GMP and GCP • Advising health care professionals and pharmaconomists on professional matters• Conducting medicine reviews of polypharmacy patients• Project coordinator which involved teaching children about the use of medicine and adverse effects • Good collaboration and communication skillsGrade: 12 (A)

• Case handling• Customer complaint handling• Handling of compliance data• Configuration of manuals• Archiving of files

• Packaging of pharmaceuticals for the Danish pharmacies and hospitals• Responsible for quality control of medicine packing in the control and crediting department • Control of sterile products• Experience in GMP and GDP• Training of new employees• Working under tight deadlines with high quality requirements

Enrolled In The Course ‘Principles And Practice Of Bioanalysis’

The course covered the complete bioanalytical process and included both experimental work as well as theoretical lectures. It included.

Lifecoach, Positive Psychology

As a certified Life Coach, I have achieved tools and skills to help clients make meaningful life changes. I have acquired skills so I.

M.Sc. In Pharmacy

Education record

Kemi, Matematik Og Tysk Højniveau, A