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 an******** animal study.
Essential Responsibilitie******** 1. Operate single use MAB productionl******** including buffer mixing system, chromatography system, UF/DF,harvest, Nano-filtration.

2. Review technical transfer documents an******** batch recordsaccording to customer’s process.

3. Execute downstream purification process according to SOPs an********Records. Able to solve downstream technical issues independently.

4. Assist scientists to execute downstream lab scale researchan********. Support downstream process development an******** upstudies.

5. Manage raw materials an******** storage an********. Maintainequipment an******** facility (water, power an********).

6. Keep downstream cleanroom quality an******** with CIP, SIP,an******** management.
Qualification******** 1. Bachelor above, major in B********Pharmaceut******** Me******** B******** Bacter******** or equivalent.

2. At least 2 year working experience in biopharmaceutical ********either pilot plant or GMP manufacturing plant.

3. Operation experience in clean room, accoring to SOPs an********records.

4. Goo******** on work skills in single use systems, chromatographysystems, bags, tubing connector, filters.

5. Understan******** operation requirement.

6. Willing to learn new technology an******** your self to be ascientist or project manager in biopharm field.

7. Excellent writing an******** skills in English an********.

8. Excellent computer skills for document management.
Additional Eligibility Qualification********
Desire****************
- Master degree in relavant file******** 3+ years industrial experiencein GMP biopharmaceutical manufacturing.
- Experience in preparing IND an******** documents.
- Proven excellence in commun******** presentation an******** skills.
- Demosntrate******** to deliver results while working on multipleproject s******** in a cross-functional team in an internationalenviorment.
- Enthus******** opt******** self-motivate********.
- Intell******** in-depth technical approach.
- Reliable an******** person who always delivers on promises an********promises realistically.
- Goo******** skills.