Lana Sweet

WORK HISTORY

EDUCATION

SKILLS

ABOUT LANA SWEET

Led multiple US and international projects, coordination of efforts of numerous internal and external groups Supervised of up to 30 direct and indirect reports; experience includes (but not limited to) hiring of qualified candidates, performance appraisals, promotionsExcellent working knowledge of FDA, EMEA, Japanese and other regulatory inspections, significant experience in preparation of responses to the inspections, interactions with FDA in client’s behalf In-depth knowledge of 9CFR and ICH guidelinesCustomer Service (broad customer base – North America, Europe, Asia) –client communications, conference calls, problem resolutionSales and Marketing expertise. Extensive experience in laboratory equipment validations - IQ/OQ/PQ (incubators, refrigerators, freezers, ultra low freezers (LN2), centrifuges).Assay validations (to comply with current regulations).Cell based assay for the antiviral drug release testing (small molecules) – assay/technology transfer, assay development, assay validationsQuality Control, Biochemistry, Analytical Chemistry, Immunochemistry (ELISA), Process Validations, Molecular BiologyVirology and viral propagation (human, porcine, bovine, murine viruses and retroviruses), viral stocks production, determination of virus stock titers, viral detection methods (cytopathology, immunofluorescence, hemadsorption, hemaggitination, hemagglutination inhibition and others)Vaccine production (Phases 1 and 2) – cell-based and egg-based vaccines;Propagation of various adherent, biphasic and suspension cell lines (mammalian and insect) Stem cell line propagationMammalian and insect cell banking and cryopreservation (cGMP and R+D) Method & technology transferSpecialties: Operation Management, Project Management, Customer Service, cGMP, GLP, Quality Control,Mammalian and Insect Cell Culture, Cryopreservation, Cell BankingVirology and Viral Propagation