Dunja Božić
Zagreb,Croatia
Summary
Analytical Project Leader and an experienced Researcher Scientist with over 10 years of experience in the pharmaceutical industry, skilled in analytical chemistry, stability programs, and regulatory submissions. Proven leadership skills as a Project Leader and a track record of successful project implementation. Demonstrated expertise in problem-solving, time management, and effective communication. Adept at research, drug development, and analytical skills.
Overview
12
12
years of professional experience
Work History
Principal Analytical Scientist, Project Leader
PLIVA
01.2020 - Current
- Led design, development, and execution of analytical methods for characterization of API, excipients, and final product
- Supervised and directed verification, validation, and transfer of analytical methods
- Prepared and reviewed analytical development and registration documentation for API, excipients, and finished product
- Reviewed and evaluated results of stress, stability, and compatibility studies
- Coordinated sample analyses during development, scale up/trial, process validation, and pilot/pivotal batches
- Contributed to Quality by Design (QbD) and Design of Experiments (DOE)
- Contributed to formulation development and process optimization
- Introduced new methods and technologies for sample analysis
- Utilized problem-solving skills during the development phase
- Coordinated preparation of answers for regulatory questions
- Engaged in CAPEX planning and realization
- Conducted SOP audits and reviews
- Established specifications for API, excipients, and final drug product
- Ensured compliance with GMP and other scientific methodology and regulatory requirements
- Participated in global groups and initiatives as analytics representative: SME for E&L, SME in Rheology knowledge sharing forum, Momentum Monitoring Program (Mentee and Mentor)
- Organized and led R&D’s internal knowledge sharing initiative.
Scientist, Analytical Project Leader
PLIVA
01.2019 - 01.2020
- Coordinated and reviewed method development of API, excipients, and final product
- Supervised and directed verification, validation, and transfer of analytical methods
- Prepared and coordinated analytical development and registration documentation
- Coordinated sample analyses during development, scale up/trial, process validation, and pilot/pivotal batches
- Organized API, excipients, and final product release analysis
- Participated in specification setting and justification
- Audited and reviewed analytical documentation
- Supervised stress and compatibility studies
- Participated in preparation of answers to Deficiency Letters
- Participated in Quality by Design (QbD) and Design of Experiments (DOE)
- Contributed to formulation development and process optimization
- Participated in CAPEX planning and realization
- Introduced new methods and technologies for sample analysis
- Conducted SOP audits and reviews
- SME for Electronic Laboratory Notebooks (ELN).
Lead Researcher - Analyst
PLIVA
10.2018 - 01.2019
- Developed, validated, and transferred analytical methods for API, excipients, and final product
- Responsible for sample analyses during development, scale up/trial, process validation, and pilot/pivotal batches
- Participated in API, excipients, and final product release
- Conducted audit and review of analytical documentation
- Conducted stress and compatibility studies
- Prepared analytical development and registration documentation
- Assisted in preparation of answers for Deficiency Letters
- Participated in QbD and DOE initiatives
- Contributed to CAPEX planning and realization
- Introduced new methods and technologies for sample analysis
- Sourced chemicals, standards, and laboratory materials
- Conducted SOP audit and review
- SME for Electronic Laboratory Notebooks (ELN).
Senior Researcher-Analyst
PLIVA
01.2017 - 10.2018
- Developed, validated, and transferred analytical methods for API, excipients, and final product
- Conducted sample analyses for development, scale up/trial, and pilot/pivotal batches
- Prepared analytical development and registration documentation
- Introduced new methods and technologies for sample analysis
- Executed qualitative and quantitative analysis
- Conducted stress studies
- Participated in preparation of answers for Deficiency Letters
- Authored SOPs
- Sourced chemicals, standards, and laboratory materials
- Participated in qualification of equipment
- Conducted audits of analytical documentation.
Researcher - Analyst
PLIVA
01.2013 - 12.2016
- Developed, validated, and transferred analytical methods for API, excipients, and final product
- Conducted sample analyses for development, scale up/trial, and pilot/pivotal batches
- Prepared analytical development and registration documentation
- Executed qualitative and quantitative analysis
- Conducted stress studies
- Authored SOPs
- Sourced chemicals, standards, and laboratory materials
- Participated in qualification of equipment.
Education
M.D. - Analytical and Physical Chemistry
Faculty of Science Zagreb
Zagreb12.2012
Skills
- Research and Development
- Analytical Characterization
- GMP and Regulatory Requirements Compliance
- Planning and Monitoring
- Workload Prioritization
- Team Work
Languages
Croatian
Native language
English
Proficient
C2
Hobbies
- Paragliding, Croatian national team member
- Aerial Silks
- Yoga
Timeline
Principal Analytical Scientist, Project Leader
PLIVA
01.2020 - Current
Scientist, Analytical Project Leader
PLIVA
01.2019 - 01.2020
Lead Researcher - Analyst
PLIVA
10.2018 - 01.2019
Senior Researcher-Analyst
PLIVA
01.2017 - 10.2018
Researcher - Analyst
PLIVA
01.2013 - 12.2016
M.D. - Analytical and Physical Chemistry
Faculty of Science Zagreb
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