- (Boston)Hengrui Pharma • Boston, MA, United States
- (Boston)
Hengrui Pharma • Boston, MA, United States
12 days ago
Job type
- Full-time
Job descriptionAKTAGMPParticipate in pilot-scale purification process development (e.g., operation of AKTA systems), complete process scale-up and technology transfer to GMP manufacturing. SOPIND / BLADevelop technical documentation (process protocols, SOPs, validation protocols) and support IND / BLA submission dossier preparation. Evaluate novel purification technologies (e.g., continuous flow chromatography, membrane chromatography) for potential implementation. Oversee daily instrument maintenance and other downstream process development-related tasks. Masters degree or above in Bioengineering, Biochemistry, Pharmaceutical Engineering, or related disciplines. Research projects involving protein purification experiments, with hands-on experience in operating relevant instruments. Strong English proficiency (listening, speaking, reading, writing), capable of fluently interpreting English technical literature and conducting technical communication with international peers. 1Western BlotAKTAProficient in fundamental experimental techniques (e.g., column packing , Western Blot ); Priority given to candidates with AKTA system operation experience . 2Understanding of downstream purification workflows (e.g., affinity chromatography, ion exchange). 3Excel / UNICORNBasic data analysis capabilities (Excel / UNICORN software). Strong learning agility and deep interest in biopharmaceutical process development. Systematic thinking and data analysis skills, adaptable to fast-paced R&D environments. Independent problem-solving skills and cross-departmental collaboration mindset.
Process Development & Optimization
- / / / / Lead downstream purification process development and optimization for biologics, including depth filtration, chromatography (affinity / ion exchange / hydrophobic interaction), ultrafiltration / diafiltration, virus inactivation / removal, etc.
- CQACPPAnalyze Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) during purification, addressing challenges in yield, purity, host cell protein (HCP) residues, etc.
Technology Transfer & Regulatory Submissions
Platform Development & Management
/ / / Shanghai / Suzhou / Guangzhou / Lianyungang
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Boston • Boston, MA, United States
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