Angela Dekoninck
Msat Chemistry Group Lead @Corden Pharma - A Full-Service CDMO
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WORK HISTORY
Msat Chemistry Group Lead @Corden Pharma - A Full-Service CDMO
Boulder, CO, US
Supervised 10 chemists (4 process chemists, 5 analytical chemists, 1 technical writer), ensuring compliance, accuracy, and scientific soundness in support of commercial production for 12 products. •Prioritized and coordinated efforts and assignments with staff and upper management to ensure production schedule adherence to address commercial investigations, deviations, or process continuous improvement.•Planned, prioritized, and formulated projects, and identified resources required to improve process throughput, cost effectiveness, and overall robustness. •Worked with production, deviation team, training group, quality control, development, and quality to identify high level trends occurring in production (such as defects, increased cycle times, operational issues, lack of general robustness) and worked to implement corrective and preventative actions. •Provided written process, analytical, and purification procedures and reports supporting commercial manufacturing and regulatory needs. •Developed/optimized, authored, and reviewed analytical and purification methods, specifications, and batch records for commercial products (raw materials, intermediates, drug substances, cleaning) including change controls.•Ensured that improvements were constantly identified, prioritized, and implemented as well as process improvements, technology transfers, and process robustness.•Identified technical, business, and interpersonal skill development needs of the members of the department, recommended appropriate training, and ensured training occurred.•Implemented and oversaw method and specification lifecycle at Corden, ensuring up to date compliance and suitability of analytical methods and ~1500 specifications.•Excellent communication skills used to inform customers, management, and team members of current status of each project.•Proven skills in managing day to day tasks for a large team and working cross-functionally to accomplish deadlines and objectives.
EDUCATION
Purdue University
Bachelor of Applied Science (BASc), Biochemistry
SKILLS
ABOUT ANGELA DEKONINCK
Research scientist with 16 years analytical laboratory experience (professional and academic) • Proficient with ICH, USP, and cGMP/cGLP regulations• Competent in analytical testing for the purpose of method development, pre-validation, verification / validation, and product release• Lab experience includes analysis of raw material, active pharmaceutical ingredients, and finished drug products for stability, potency, purity, and identification; validation / transfer of methods and protocols; testing of generic drug products for ANDA submission; dose formulation testing• Proficient in maintaining and repairing HPLC and IC equipment• Experienced in writing scientific reports, presenting scientific data, and experimental design
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