Job Description

Responsible for rational design and chemical modification optimization of siRNA/oligonucleotide drug sequences; conduct off-target risk prediction, bioinformatics analysis and sequence homology screening; collaborate with chemistry and cell biology teams to verify gene silencing specificity and molecule stability; sort out experimental data and support preclinical project design and IND application document preparation.

Qualifications

Master/PhD degree in Bioinformatics, Molecular Biology, Genetics or related majors.

Core Skills

Proficient in siRNA design tools, off-target prediction software, NGS data analysis, Python/R programming.

Job Description

Complete solid-phase chemical synthesis, purification and structural modification of siRNA, ASO and other nucleic acid drugs; operate HPLC, mass spectrometry and other analytical instruments for product identification and purity detection; develop and optimize oligonucleotide synthesis processes, explore new chemical modification technologies; write standard experimental records and technical research reports.

Qualifications

Master/PhD degree in Organic Chemistry, Medicinal Chemistry, Nucleic Acid Chemistry or related majors.

Core Skills

Oligonucleotide synthesis technology, chromatography and mass spectrometry instrument operation, organic synthesis and molecular modification experience.

Job Description

Establish and optimize in vitro cell efficacy evaluation models for RNA targeted drugs; carry out qPCR, Western Blot, cell uptake and cytotoxicity detection experiments; validate the delivery efficiency of GalNAc, LNP and other delivery systems; complete in vitro pharmacodynamic evaluation and molecular mechanism research of preclinical compounds.

Qualifications

Master or above degree in Cell Biology, Biochemistry, Molecular Biology or related majors.

Core Skills

Professional cell culture technology, molecular biology experiment operation, drug in vitro screening and efficacy evaluation experience.

Job Description

Design and implement in vivo pharmacodynamic, pharmacokinetic (PK/PD) and preliminary safety evaluation studies of siRNA drugs; establish and optimize animal models of tumors, metabolic diseases and fibrotic diseases; detect drug tissue distribution and gene knockdown effect in vivo; complete standardized preclinical research reports and support IND application data sorting.

Qualifications

PhD preferred, Master degree in Pharmacology, Pharmacy, Veterinary Medicine or related majors.

Core Skills

In vivo animal experiment operation, PK/PD data analysis, GLP preclinical research process management.

Job Description

Develop and optimize GMP-compliant production processes for oligonucleotide drugs; carry out process research on nucleic acid preparation, purification, formulation and filling; complete process validation, technology transfer and large-scale production tests; control process impurities and ensure product quality consistency, and cooperate with QA to meet pharmaceutical production compliance requirements.

Qualifications

Master or above degree in Pharmaceutical Engineering, Chemical Engineering, Pharmaceutical Sciences or related majors.

Core Skills

Oligonucleotide CMC process development, GMP standard awareness, drug production process scale-up and validation experience.

Job Description

Establish and verify analytical testing methods for nucleic acid drug raw materials, preparations and finished products; carry out purity, impurity, content, stability and conformational analysis of products; proficiently operate LC-MS, HPLC, capillary electrophoresis and other detection platforms; support product batch release, stability research and regulatory submission of CMC data.

Qualifications

Bachelor/Master degree in Analytical Chemistry, Pharmacy, Pharmaceutical Analysis or related majors.

Core Skills

Chromatography and mass spectrometry instrument operation, analytical method verification, drug quality control testing.

Job Description

Prepare and submit IND, NDA and other registration dossiers for China, the United States and the European Union; track global regulatory policies and guidelines for oligonucleotide drugs; coordinate cross-functional teams to collect and sort clinical, preclinical and CMC registration data; respond to inquiries from regulatory authorities and manage the full lifecycle of product registration.

Qualifications

Master or above degree in Pharmacy, Biopharmacy, Pharmaceutical Affairs or related majors.

Core Skills

eCTD dossier filing, NMPA/FDA/EMA regulatory experience, proficient professional English writing ability.

Job Description

Responsible for site management and monitoring of Phase I-III clinical trials of RNA targeted therapeutics; supervise clinical sites to carry out trials in accordance with GCP and trial protocols; collect, verify and sort clinical trial data, track adverse event reporting; promote the progress of clinical projects and ensure the authenticity and compliance of trial data.

Qualifications

Bachelor/Master degree in Clinical Medicine, Pharmacy, Public Health or related majors.

Core Skills

GCP certificate, clinical site management, clinical trial data review and compliance control.