北京招聘

Essential Responsibilities
1. Do assay development and validation of protein/cell therapy/gene therapy and related activities to support GE Healthcare Life Science Fast Trak China non-GMP pilot scale 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/gene/cell 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 products(protein/virus/DNA) stability research, including short term and long term.
5. Execute QC activity to support lab scale upstream cell culture and downstream purification process development including cell culture medium analysis (trace element, lipid and amino acid)
6. Can take assay development by different analysis equipment, such as Caliper CE, solo-VPE, HPLC(UPLC), QPCR, SDS-PAGE and Agarose gel electrophoresis, flow cytometer.
7. Establish QC SOPs, familiar with QMS, cGMP, FDA guidelines, data integration and deviation workflow.
8. Prepare CMC documents for IND.

Role Summary/Purpose

Responsible for providing protein/DNA/virus analytical support for process development projects and pilot scale manufacturing, including in process control and bulk drug release test and method development &validation. Find，qualify and manage the third-part to get qualified QC test report for projects, including protein characterization, bio-similar comparability test, plasmid analysis etc.

Qualifications/Requirements

1. Master on analytical or biochemical scientist. Have several (≥2) years of practical experience in QC or AD department of 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, such as HPLC, UPLC, CE, Q-PCR, Elisa, cIEF, SDS-PAGE, etc.
3. Has good understanding and knowledge in protein and DNA or virus characterization and analysis technology.
4. Familiar with GMP QC management with records, data integration, SOPs, and cFDA filing.
5. Good personality skills. Proven ability to work in team environment and able to develop lasting working relationship with customer.
6. Able to work under pressure and tight time frame.
7. Good written and spoken communication skills in English and Chinese.

Desired Characteristics

• 3+ 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.
• Excellent written and spoken communication skills in English and Chinese.

About Us

GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com

GE医疗集团提供革新性的医疗技术和服务，以满足需求，使全世界更多的人能以更可负担的成本获得更好的医疗服务。GE专注于世界至关重要的问题，以优秀人才和领先技术致力于应对行业重大挑战。GE医疗集团在医学成像、软件和信息技术、患者监护和诊断、药物研发、生物制药技术、卓越运营解决方案等多个领域，助力专业医务人员为患者提供优质的医疗服务。