Jinse Kim

Samsung BioLogics

07.2016 - Current

8 years experience as downstream MSAT tech transfer SME supporting various manufacturing campaigns, with experiences in early tech transfer for engineering/clinical runs to continuous process verification activities for fully commercial campaigns
Excellent collaboration work with external partners and internal cross-functional teams for successful technology transfer projects with strict deadlines
Worked as leader of a unit consisted of 4 scientists, and provided technical advice to 20+ junior scientists as a senior downstream tech transfer SME
Authored multiple tech transfer documents including process control strategies, process validation master plans and quality risk assessment documents.
Designed and executed various process validation activities such as buffer/product mixing studies, filter sizing, lifetime studies (UFDF membrane, resin lifetime), impurity mapping, reprocessing, etc. to support successful process validation.
Owned and completed technical investigations for deviations, out of trends, non conforming results, etc.
Participated as downstream tech transfer SME in multiple health authority inspections, including FDA, EMA, PMDA and MFDS
Experience in various tools used in biopharma industry such as Unicorn, JMP, PI Historian, etc.

Summary