Shannon Kihlstrom

Pharmacy Manager @Petnet Radiopharmaceutical Solutions Private Limited

Cleveland/Akron, OH, US

Managed a cGMP facility for PETNET with multiple product lines. Responsible for hiring and training of staff, and the installation and performance of multiple biomarkers from several companies using four different chemistry platforms. Led 2 major projects in the shutdown and restart of the facility due to infrastructure failure. Responsible for restarting production after shut down including IQ,OQ and PQ of all analytical and production equipment within facility for the restart. Perform internal audits of the quality systems of the site. Responsible for technical audits from our buisness partners. Perform batch review, deviation creation, CAPA implementation, and planned variances for the site. Investigates root causes of failures in both equipment and batch failures from either out of specification results or production failure. Led site tech transfer for 5 PET products; including production and quality control technology transfer. Responsible for quarterly quality assessment of our site to find similarities in failures along all product lines, batches and equipment to find improvements, that led to less failures. Responsible for the regulatory compliance for the site with the FDA, DOT, FAA, EPA and the Board of Pharmacies in the multiple states we deliver within.