OPKO Biologics, a dynamic biotechnology company with several projects in development stage is currently seeking for an Associate Director of QC and Analytical Development.
Job Description
-Leading the QC department, overseeing analytical methods development for proteins and peptides, and product release under GMP conditions.
-Responsible for diverse analytical method development and qualification, tech transfer to Contract Manufacturing Organizations (CMOs), and responsibility of managing analytical work at the CMOs.
-Leading product characterization efforts in house and at sub constructers in Israel and abroad.
-Be a part of the CMC management team- maintaining a strong interface with Upstream, Downstream, Chemistry and QA managers.
Requirements
·At least 3 years of industry experience in QC or Analytical Development management – Required
·Proficiency in HPLC based method development and qualification- Required
·M.Sc. or PhD in Biology, Biochemistry or Biotechnology – Required
·Expertise in GMP work (deviation management, investigations, CAPA, CC)
·Knowledge and experience in protein analysis and characterization
·Experience in analytical method development and biochemical methods such as: ELISA, q-PCR, IEF, Western Blot, SDS-PAGE- advantage
·Very good English – reading, writing and verbal communication.
Experience in protocols, reports and SOPs writing in English
·Demonstrated capability for precision, responsibility, and thoroughness in work
·Flexibility to lead development work and GMP work in the same lab
·Strong organizational skills and excellent interpersonal abilities
The company is located in Kiryat-Gat.
Submit your CV to jobs.obl@opko.com
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