- Manage own time and professional development, be accountable for own results and begin to prioritize own workflow ·
- Conduct formulation studies includes and not limited to developability study, formulation screening, container closure study, forced degradation study, clinical in-use study and stability study ·
- Conduct process developement studies includes and not limited to holding time, freeze-thaw, pooling and mixing, pumping stress, light exposure, material contact compatibility and lyophilization parameter study ·
- Conduct DP related analytical testings includes and not limited to Appearance inspection, pH, concentration by UV, osmolality, density, viscosity, DLS, DSC, purity by HPLC, charge variance by cIEF, CCIT, extractable volume and do relevant data analysis ·
- Take part in the DP related late phase work for BLA includes and not limited to Quality Risk Management, Formulation and Process Characterization, E&L study, shipping study, Control Strategy determination, scale-up/scale-down model development and application ·
- Complete documentation includes and not limited to writing study plan, logbook, technical report, tech transfer protocol, investigation report and IND/BLA filing following compliance and data integrity princple. ·
- Ability to follow Standard Operating Procedures and work under minimal supervision ·
- Work as SME or FL in Cross-functional communication with internal team or client as necessary ·
- Participate routine lab maintatinance includes and not limited to material and instrument management ·
- Complete training to take part in safety inspections within the BSL-2 lab ·
- Understand and comply with the policies, procedures and working practices of Environment, Health & Safety and where necessary contribute to the review and implementation of the practices · Help to coordinate shipments of solutions, medias and filled vials/syranges to other sites
WuXi Biologics
Offering End-to-End Solutions
职位信息
职位信息
Scientist, Drug Product Development
Scientist, Drug Product Development
中国 杭州
工作职责：
任职能力：
- B.Sc. or B.Eng. in Biotechnology, Chemistry, Microbiology, Pharmaceutical Science, or Chemical/Biochemical Engineering ·
- 2+ years of experience in liquid/lyo formulation development and DP process work. ·
- Broad knowledge in the physicochemical property and characterization method of biological molecules (e.g. mAb, BiAb, fusion protein, recombinant protein, ADC, enzyme, plasmid, AAV, LV, and other vaccine/gene therapy related molecule, etc.) ·
- Broad knowledge in DP related NMPA，FDA，EMA，ICH Regulations and Guidance. ·
- Specialist technical skills and demonstrated experience in a biopharma manufacturing or laboratory environment ·
- Operational knowledge of computerized systems ·
- Familiarity with injectable excipient and relevant function. ·
- Familiarity with injectable DP development procedure and related analytical testing. ·
- Demonstrated capability to work as a team member in a matrix development team ·
- Demonstrates flexibility and ability to respond quickly ·
- Ability to handle multiple tasks at one time and prioritize effectively ·
- Results and strategy oriented ·
- Demonstrates initiative and a proactive attitude ·
- Demonstrates personal leadership and understands the impact of own behavior ·
- Ability to lead, coach and supervise others and help others improve ·
- Excellent oral and written communications skills in both Chinese and English ·
- Ability of literature research and Trouble-shooting ·
- Maintains a safe work environment Nice-to-Have ·
- Experience in drug product processes of recombinant virus and/or plasmid ·
- Knowledge of Total Quality Management (TQM) principles, Lean Manufacturing and Six Sigma tools
- Key Relationships Internal ·
- PD downstream, Analytical Science, Operations, DP Manufacturing, Quality Assurance, Supply Chain, Regulatory Affairs and Engineering/Technical Services. External ·
- External consultants, Global Wuxi Biologics sites, clients