制剂研究员/Research Investigator, Formulation(博士岗)
百济神州
岗位职责
制剂研究员/Research Investigator, Formulation(博士岗)
发布于 2026-03-17
Tech Ops and Manufacturing
Tech Ops and Manufacturing
|
全职
全职
|
广东·广州市
广东·广州市
General Description: This position is in Formulation and Drug Product Development Department in BeOne Medicine’s Biological Technical Development function. Within the department, the qualified candidate will be responsible for biological drug product (including antibody and ADC molecules) development from early-stage through to commercial launch. Essential Functions of the job: 1)Serve as a formulation lead to develop a robust formulation and DP process to for early-stage and late-stage biological programs, including antibody and ADC molecules. Responsible for formulation and DP process development and technology transfer.2)Act as a functional representative in cross-functional teams, and collaborate with key stakeholders (BioTD functions, research, CMC, Quality, MST/manufacture, Reg CMC, clinical operation, etc.) to advance the technical development of new biologics entities according to aligned program timeline. Enable IND/NDA/BLA submission per aligned CMC timeline. 3)Provide technical support for GMP deviation investigations.4)Serve as a key contributor to author and/or review regulatory dossier for IND/NDA/BLA submission and regulatory interaction materials. 5)Stay current with emerging formulation and DP development technologies. Evaluate state-of-the-art technologies and implement suitable ones in BeOne FDPD department. Lead formulation and DP platform establishment and optimization by introducing novel technology or improving operational excellence. 6)Provide effective solutions to technical issues for biological products. 7)May coach junior scientists in FDPD development work.Qualifications:1)PhD in pharmaceutical sciences, biochemistry, chemical engineering, or relevant field, with 0-2 years of experience in formulation and/or DP development in the biopharmaceutical industry. 2)Proficient experimental skills, able to independently design stability studies, execute experiments, interpret the data and draw scientifically solid conclusions.3)Familiar with formulation methodologies and equipment, such as MFI, DLS, visual inspection, viscosity, etc. is a plus.4)Demonstrated self-motivation with strong troubleshooting and problem-solving skills. 5)Proficiency in English reading, writing, and speaking. 6)Excellent interpersonal skills with a collaboration spirit. Results-driven with high ag
任职要求
ility in a dynamic environment.
General Description:
This position is in Formulation and Drug Product Development Department in BeOne Medicine’s Biological Technical Development function. Within the department, the qualified candidate will be responsible for biological drug product (including antibody and ADC molecules) development from early-stage through to commercial launch.
Essential Functions of the job:
1)Serve as a formulation lead to develop a robust formulation and DP process to for early-stage and late-stage biological programs, including antibody and ADC molecules. Responsible for formulation and DP process development and technology transfer.
2)Act as a functional representative in cross-functional teams, and collaborate with key stakeholders (BioTD functions, research, CMC, Quality, MST/manufacture, Reg CMC, clinical operation, etc.) to advance the technical development of new biologics entities according to aligned program timeline. Enable IND/NDA/BLA submission per aligned CMC timeline.
3)Provide technical support for GMP deviation investigations.
4)Serve as a key contributor to author and/or review regulatory dossier for IND/NDA/BLA submission and regulatory interaction materials.
5)Stay current with emerging formulation and DP development technologies. Evaluate state-of-the-art technologies and implement suitable ones in BeOne FDPD department. Lead formulation and DP platform establishment and optimization by introducing novel technology or improving operational excellence.
6)Provide effective solutions to technical issues for biological products.
7)May coach junior scientists in FDPD development work.
Qualifications:
1)PhD in pharmaceutical sciences, biochemistry, chemical engineering, or relevant field, with 0-2 years of experience in formulation and/or DP development in the biopharmaceutical industry.
2)Proficient experimental skills, able to independently design stability studies, execute experiments, interpret the data and draw scientifically solid conclusions.
3)Familiar with formulation methodologies and equipment, such as MFI, DLS, visual inspection, viscosity, etc. is a plus.
4)Demonstrated self-motivation with strong troubleshooting and problem-solving skills.
5)Proficiency in English reading, writing, and speaking.
6)Excellent interpersonal skills with a collaboration spirit. Results-driven with high agility in a dynamic environment.
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