Agata Panas-Adamson

Cardiac Safety

Leading the Planning and Setup, Monitoring, and Closeout phases of study management which includes:

• Gathering customer requirements and relaying to internal teams
• Appropriate setting and fulfilling of customer expectations
• Established effective communication among team members for enhanced collaboration and successful project completion.
• Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
• Monitoring study timelines and manage the financial components of each program/study, which includes: budget reviews, revenue forecasting, scope changes, invoice reconciliation
• Identifying potential study risks and mitigations and escalate as appropriate
• Managing internal/external negotiations and promote collaboration to foster a positive team environment, effective communications, and efficient use of resources to meet study timelines and contractual obligations
• Applying problem solving strategies to address customer issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to customer escalations

Achievements:

• Completed industry gold standard Project Management Institute (PMI) course to gain Project Management Professional Certification

Pharmaceutical CMC, Small Molecules

• Managing a team of highly skilled scientists
• Providing technical and scientific expertise in analytical method development, validation and transfer
• Project managing - running monthly proficiency analysis and meeting financial targets
• Primary client contact for technical requests, proposal writing and price negotiation
• Hosting and leading scientific client visits and TC’s
• Ensuring work is conducted to applicable compliance (cGMP, ICH)
• Internal auditor for cGMP compliance

Achievements

• Improved process of price negotiation that increased department profitability
• Developed passion for people leading and interest in financial aspects of business management

Biopharmaceutical, CMC Large Molecules

• Managing my own projects with client facing responsibilities
• Developing a variety of analytical techniques for antibody characterization (impurities, aggregation, oxidation, hydrolysis) using variety of analytical techniques
• Establishment of study methods, ensuring procedures are scientifically sound and meet client/regulatory criteria
• Analyst leading and supervision

Achievements

• Developed a suit of techniques for characterization of a variety of Biosimilar molecules
• Optimized and introduced complex amino acid methodology into the department

Nutritional Chemistry and Food Safety

• Setting up a newly opened laboratory
• Independent conduct of a variety of analytical techniques, method transfers and optimizations for the chemical evaluation of food, drink and supplement products
• Planning the workload/training of less experienced staff
• Team leader for the superusers of the laboratory information management system (LIMS) - making sure software updates are executed on time

Achievements

• Became an independent and creative scientist
• First insights and enjoyment into method development and people management

Pharmaceutical, CMC Small Molecules

• Performing a variety of analytical techniques for the chemical evaluation of API and finished drug products as part of stability testing and batch release
• Using equipment such as HPLC, UPLC, GC-MS, UV-vis with methods including assay, dose content, related substance, particle size distribution (ACI), dissolution
• Troubleshooting equipment and methodology problems
• Training less experienced analysts, calibration and maintenance of laboratory equipment

Achievements

• Became confident in a cGMP environment
• Discovering passion to non-routine type of projects