JIUN-LIANG LIN

Major contributor of Biothues integration into BNT. Lead multiple Antibodies and ADC from preclinical to clinical material supply. Lead domestic and overseas TT License out, DD and QP inspection

Lead full-function PD and pilot scale manufacturing team Lead license out projects of CMC activities Lead domestic and overseas Tech Transfer and facility relocation Lead preclinical and phase I process development Lead PC and PPQ for phase III project

Lead overseas and domestic manufacturing technology activities. Major contributor for the on-site Pre-Approval Insepection in China

Report to CEO Oversee all the overseas activities, including the business, materials, and technologies. Internal and external operation and coordination.

Report to CEO and lead the MSAT team. The omicron vaccine:B.A.1 and B.A.4/5 successfully IND filing and/or Phase III in the United Arab Emirates and Indonesia. IL-12 mRNA IIT and IND in China As a major contributor investigate the OOT, find out the root cause, and improve the product quality Lead the oversea tech transfer project： like Etana in Indonesia with multi valent project Key contributor to lead part of the EUA project validation works Communication with several FDA for IND filing or EUA. Wild type mRNA vaccine EUA in Indonesia

Build up the MSAT Team and lead the manufacturing activities of various mRNA projects in the absence of the Head of manufacturing, including the IND lots of different projects： Omicron variant and multi valent vaccine. The projects included the vaccines or therapeutic product which are manufactured in house or outsourced. Lead the tech transfer activities internally, externally and oversea. Design the pilot and commercial facility in different sites. Oversee the manufacturing activities of DS and DP. Build up the MSAT lab for process scale-up testing, optimization and robustness.

After accepting the offer, provide consulting services during the quarantine

Lead the PD to launch the Covid19 testing kit "In Fung" to the Taiwan market

As a bridge to build up CDOM business strategy: Alliance with all functional groups including PD/Manufacturing, QA/QC, Operation, Marketing, Sales, Finance, Purchasing and Warehouse. Lead to draft CDOM Quality Agreement Head of DSPD and FD team for early-stage process development and manufacturing for IND filing. Improve the preclinical and phase I and II manufacturing facility and set up the FAT/SAT/IOP Q/Clean qualification. CMC lead for CDOM business. Support BD and marketing to approach global potential clients in Asia and the USA.

Lead PD/Pilot/2K scale purification

Head of Purification Process development and pilot scale manufacturing Lead multiple projects from PD to pilot scale in parallel. Two projects completed DS/DP development works for IND filing both in China and US.

CMC lead for CMO projects including cell line, cell culture, purification, analysis, formulation and fill-finish. Lead to draft whole IND filing document in CTD format and communicate with CDE

Head of Purification process development, technical transfer and up to 250 L pilot scale GMP compliant manufacturing Build up downstream process development platform for MAb and recombinant protein. Develop up-to-date downstream process. Hiring, Training and Budgeting and GLP/GMP training. Report to GM of China gateway biologics. CMO project proposal of Timeline, FTE and Budget and cross function communication. Lead to build up 2K SU system. cFDA onsite inspection for IND filing.

Oversee the projects in process development group Proposal writing for downstream: CMO and Co-development Communication with CMO client for overall yield, product/process related purity and DS concentration. Build up pilot scale purification process in PD lab and it's execution. Orphan protein drug purification process preliminary locked for pilot scale production. CMO project submitted IND in Australia Two internal biosimilar file IND in EU

Maintain the operation of whole PD lab. Department annual Budgeting Project owner of downstream process development. Hands on: Biosimilar development of MAb and Orphan drug purification process development CMO project of MAb new drug tech. transfer from Client to PD lab and from PD to Mfg. Build up TPP (target product profile) for biosimilar Reviewing batch record. CMO project of MAb new drug tech. transfer from client to PD lab and from PD to Mfg. File one chromatography patent in US, EU and Taiwan Project leader of government grant project

Build up PD lab and maintain the operation of whole PD lab. Design and build up PD/AD/QC/AD lab: footprint design, power/water system,specification of equipment, purchasing, delivery and installation and IQ/QO FAT of all 50~500 L scale downstream Xcellerx and AKTA system Project owner for downstream process development. Biosimilar development: MAb and Orphan drug purification process development hands on experiences. Hands on developing unique downstream process for Orphan protein drug and file patent. Quick assay develop Annual department budgeting. Build up pTTP for biosimilar (orphan drug and MAb).

E. coli system fermentation development: Interferon alpha and G-CSF Inclusion bodies recovery optimization from cell lysates Protein refolding process improvement and purification process development Increase 100% refolding yield of Interferon alpha, minimize the refolding time from 24 to 3 hrs and increase the success rate from 50% to 100%. Phase II clinical trial material production of upstream E. Coli system Develop high-through-put assay for recovery estimation method cGMP facility build up Feb 2019, P1101 get marketing authorization in EMA.

Analytic assay development for protein vaccine Lead the SBIR project

Downstream process development

Major in Protein Purification and Protein Refolding