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Role Summary: Responsible for providing protein analytical support to pilot scale manufacture, including in process control and bulk drug release test. Manage the third-part contracted supplier to get qualified QC report to pilot scale manufacture, including protein characterization, bio-similar comparability test. Provide CMC support to IND. Take charge of new assay development related to GE Healthcare Life Sciences products.
Essential Responsibilities: 1. Lead protein drug analytical, QC, assay development related activities to support GE Healthcare Life Science Fast Trak China non-GMP and GMP pilot scale CMO service. 2. Take hand-on QC work in lab for in-process test and bulk drug substance release test to provide QC report as part of non-GMP/GMP pilot scale manufacture for IND. 3. Define protein drug characterization test items and bio-similar comparability test items. Qualify CRO vendor candidates and out-source characterization and comparability test work to get qualified report for IND. 4. Be responsible for protein drug stability test, including short term and long term. 5. Execute protein QC activity to support lab scale upstream cell culture and downstream purification process development. 6. Be able to take assay development by novel analysis equipments, such as Biacore, ITC/DSC, Gyros, Caliper CE. 7. Establish QC SOPs. 8. Prepare CMC documents.
Qualifications/Requirements: Required Qualification 1. Bachelor or Master on analytical or biochemical scientist. Have several (>3) years of practical experience in QC or AD department of GMP biopharmaceuticals. 2. Practical, hands-on, industrial experience and theoretical knowledge of the basic techniques used for QC and AD of biopharmaceuticals at pilot or process scale, particular HPLC, CE, Q-PCR, Elisa, IEF, SDS-PAGE, Bio-burden, endotoxin. 3. Experienced in MAB CEX HPLC, HPLC peptide map assay development. 4. Has good understanding and knowledge in protein LC-MS to support MAB AA sequence, N- and O-Glycan profiling, monosaccharide analysis, sialic acid analysis. 5. Familiar with GMP QC management with records, SOPs, and sFDA filing. 6. Good people skills. Proven ability to work in team environment and able to develop lasting working relationship with customer. 7. Excellent written and spoken communication skills in English and Chinese.
Preferred Qualifications: • 5+ years industrial experience in GMP biopharmaceutical manufacturing. • Experience in preparing IND and NDA documents. • Proven excellence in communication, presentation and facilitation skills. • Demosntrated ability to deliver results while working on multiple project simultaenously, in a cross-functional team in an international enviorment.
Desired Characteristics: • Enthusiastic, optimistic, self-motivated achiever. • Intelligent, in-depth technical approach. • Reliable and thorough person who always delivers on promises and always promises realistically. • Good organizational skills.
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