Biomanufacture Process Engineer-Downstream 生物制药工程师-下游纯化
Role Summary/Purpose: Work in 200L pilot scale clean room forbiosimilar MAB pilot scale pre-clinical manufacturing. Prepare MAB drugin non-GMP condition for PK/PD and tox animal study. Essential Responsibilities: 1. Operate single use MAB production line,including buffer mixing system, chromatography system, UF/DF, harvest,Nano-filtration.
2. Review technical transfer documents and update batch recordsaccording to customer’s process.
3. Execute downstream purification process according to SOPs and BatchRecords. Able to solve downstream technical issues independently.
4. Assist scientists to execute downstream lab scale research anddevelopment. Support downstream process development and scale upstudies.
5. Manage raw materials and consumables storage and usage. Maintainequipment and other facility (water, power and gas).
6. Keep downstream cleanroom quality and deal with CIP, SIP, and wastemanagement. Qualifications/Requirements: 1. Bachelor above, major in Biochemical,Pharmaceutical, Medicine, Biology, Bacteriology, or equivalent.
2. At least 2 year working experience in biopharmaceutical industry,either pilot plant or GMP manufacturing plant.
3. Operation experience in clean room, accoring to SOPs and batchrecords.
4. Good hand on work skills in single use systems, chromatographysystems, bags, tubing connector, filters.
5. Understand GMP operation requirement.
6. Willing to learn new technology and develop your self to be ascientist or project manager in biopharm field.
7. Excellent writing and reading skills in English and Chinese.
8. Excellent computer skills for document management. Additional Eligibility Qualifications: Desired Characteristics: - Master degree in relavant filed or 3+ years industrial experience inGMP biopharmaceutical manufacturing. - Experience in preparing IND and NDA documents. - Proven excellence in communication, presentation and facilitationskills. - Demosntrated ability to deliver results while working on multipleproject simultaenously, in a cross-functional team in an internationalenviorment. - Enthusiastic, optimistic, self-motivated achiever. - Intelligent, in-depth technical approach. - Reliable and thorough person who always delivers on promises andalways promises realistically. - Good organizational skills.