Giordana Lepore
Cambridge,Italy
Summary
Motivated Senior Scientist with 20 years of experience in analytical method development and validation, specializing in post-translational modification analysis for biologics. Expertise in advanced electrophoresis, liquid chromatography, and HPLC troubleshooting, with strong skills in GMP documentation and IND/BLA submission.
Proven track record in leading high-performing teams, and delivering consistent results meeting company goals and promoting best practice.
Recognized for assessing operational needs and developing solutions to lead projects, company operations and business growth.
Resourceful and well-organized with excellent leadership and team-building record..
Overview
23
23
years of professional experience
2005
2005
years of post-secondary education
Work history
Senior scientist in Analytical Science
AstraZeneca
Cambridge, UK
2020.07 - 2026.01
- Directed implementation of Good Laboratory Standards in Analytical Science department.
- CMC Analytical Lead for several projects in Phase 0 and Phase 2
- Facilitated efficient project transitions by leading Technology Transfer team.
- Reviewed and approved test releases in Laboratory Information Management System (LIMS) as key person
- Authored scientific documents for IND/BLA Health Authority submissions.
- Optimized data automation processes to enhance operational efficiency.
- Applied statistical analysis expertise to improve research outcomes.
- Pursued Lean and Six Sigma Green Belt certification for continuous improvement.
- Improved efficiency and productivity by acquiring new skills.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
- Oversaw daily operations to achieve high productivity levels.
- Quickly learned and applied new skills to daily tasks, improving efficiency and productivity.
- Successfully delivered on tasks within tight deadlines.
Senior scientist and Supervisor of Analytical Methods development Lab in Protein Chemistry Department
Merck Serono
Guidonia, Italy
2006.02 - 2020.07
- Served as interdepartmental focal point for analytical activities including method development on early phase, late phase, and biosimilars.
- Established timelines in collaboration with project programme managers and departmental heads.
- Collected data from scientists according to established schedules.
- Facilitated discussions with lab heads regarding data elaboration and interpretation.
- Presented results to international teams during weekly meetings.
- Supervised junior scientists in electrophoresis and chromatography laboratory.
- Designed studies in accordance with project timelines and ensured adherence throughout.
- Oversaw experiments for method development, validation, and technology transfer.
- Key person for the team during FDA and EMA inspections.
Scientist in QC testing laboratory
Janssen- Cilag Quality Control Department MEDICAL DEVICE
Latina, Italy
2005.06 - 2006.02
- Routine testing for release in the Medical Device department.
- HPLC troubleshooting key person
Scientist in pharmacokinetic and metabolism department
Sigma Tau SpA
Pomezia
2004.10 - 2005.06
- Developed analytical methods for new synthetic molecules using HPLC-FLR and HPLC-MS.
- Supported preclinical GLP studies for novel anticancer molecules.
- Conducted routine analysis, processing, and interpretation of data from preclinical and clinical studies under GLP.
- Drafted SOPs for Pharmacokinetic and Metabolism department.
Internship at Pharmacokinetics and Metabolism department
Sigma Tau SpA
2003.09 - 2004.09
- Authored thesis entitled 'Pharmacokinetic and Metabolism of a New Camptothecin with anti-cancer activities' during internship.
Internship in the Mass Spectrometry Laboratory
Universitätklinicum hospital
Leipzig
2003.01 - 2003.06
- Conducted new-born screening and clinical monitoring of patients undergoing chemotherapy treatment by MS.
Education
Master degree in Pharmacy - Pharmacy
University of Rome "La Sapienza"
ItalyDiploma of Higher Education - Piano
Conservatory of music
Frosinone /1992 - /2002
Diploma of Higher Education - Grammar school
Liceo Ginnasio Ugo Foscolo
Albano, ItalySkills
- Analytical Method development and validation
- Post-translational modification analysis
- Electrophoresis and LC techniques
- Protein degradation assessment
- Glycan mapping expertise
- HPLC troubleshooting and improvement
- GMP documentation generation
- Laboratory software proficiency (Empower, Open Lab, 32 Karat, Prism, Angel)
- ICH guideline familiarity
- Team leadership and coaching
- Problem-solving and decision-making
- Effective communication
- Public speaking skills
- Calm under pressure
- Strategic planning
- Resourcefulness in projects
- Leadership and team building
Knowledge Foreign Languages
English
Fluent
Italian
Native
Interests Outside Work
Sports: Running, swimming, skiing. Music.
Affiliations
- Music
- Art Gallery
- Reading
- Tennis
- Running
- Skiing
Additional Qualifications
- July 2002: diploma in piano at the Conservatory of Music of Latina” Ottorino Respighi
- Guidonia February - June 2003: “Leonardo da Vinci” Scholarship Program
Timeline
Senior scientist in Analytical Science
AstraZeneca
2020.07 - 2026.01
Senior scientist and Supervisor of Analytical Methods development Lab in Protein Chemistry Department
Merck Serono
2006.02 - 2020.07
Scientist in QC testing laboratory
Janssen- Cilag Quality Control Department MEDICAL DEVICE
2005.06 - 2006.02
Scientist in pharmacokinetic and metabolism department
Sigma Tau SpA
2004.10 - 2005.06
Internship at Pharmacokinetics and Metabolism department
Sigma Tau SpA
2003.09 - 2004.09
Internship in the Mass Spectrometry Laboratory
Universitätklinicum hospital
2003.01 - 2003.06
Master degree in Pharmacy - Pharmacy
University of Rome "La Sapienza"
Diploma of Higher Education - Piano
Conservatory of music
/1992 - /2002
Diploma of Higher Education - Grammar school
Liceo Ginnasio Ugo Foscolo