制剂研究员/Research Investigator, Formulation(博士岗)

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 | 江苏·苏州市 江苏·苏州市 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 (mainly antibody) development from early-stage through to commercial launch, including drug-device combination products such as prefilled syringe and pen-/autoinjector.Essential Functions of the job:1)Serve as a formulation lead/technical expert to develop a robust formulation and DP process to for early-stage and late-stage biological (mainly antibody) programs, including drug-device combination product (prefilled syringe, pen- /autoinjector). Responsible for formulation and DP process development and technology transfer.2)Responsible for formulation and device interaction study, device performance testing method development and transfer. Author design control documentation (design development plans, user requirements specifications, design inputs, design outputs, design verification, design validation and DHF creation/maintenance DHF), conformity assessments and risk management documentation.3)Apply knowledge of the regulatory landscape to ensure standard compliant designs (e.g. ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30).4)Act as a functional representative in cross-functional teams, and collaborate with key stakeholders (Quality, MST/manufacture, CMC, Reg CMC, Reg device, clinical operation/development, etc.) to advance the technical development according to aligned program timeline. Enable IND/NDA/BLA submission per aligned CMC timeline.5)Serve as a key contributor to author and/or review regulatory dossier for IND/NDA/BLA submission and regulatory interaction materials. 6)Evaluation of new and breakthrough technologies. Application of theoretical engineering knowledge, to establish robust technical product requirements, and develop engineering design solutions to assure devices maintain the required level of performance throughout the life of the product. Qualifications:1)PhD in pharmaceutical sciences, biochemistry, chemical engineering, or relevant field, with 0-2 years of experience in biological drug product development in the biopharmaceutical industry. Experience with prefilled syringe and/or pen- /autoinjector development is a plus.2)Sound knowledge of legislation, regulation, industry ISO standards, and guidance within the area of combination products and medical device is a plus.3)Demonstrable knowledge of drug delivery devices, parenteral drug delivery, risk assessment, design control, statistical analysis, drug delivery device assembly processes and human factor engineering 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 a

gility 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 (mainly antibody) development from early-stage through to commercial launch, including drug-device combination products such as prefilled syringe and pen-/autoinjector. Essential Functions of the job: 1)Serve as a formulation lead/technical expert to develop a robust formulation and DP process to for early-stage and late-stage biological (mainly antibody) programs, including drug-device combination product (prefilled syringe, pen- /autoinjector). Responsible for formulation and DP process development and technology transfer. 2)Responsible for formulation and device interaction study, device performance testing method development and transfer. Author design control documentation (design development plans, user requirements specifications, design inputs, design outputs, design verification, design validation and DHF creation/maintenance DHF), conformity assessments and risk management documentation. 3)Apply knowledge of the regulatory landscape to ensure standard compliant designs (e.g. ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30). 4)Act as a functional representative in cross-functional teams, and collaborate with key stakeholders (Quality, MST/manufacture, CMC, Reg CMC, Reg device, clinical operation/development, etc.) to advance the technical development according to aligned program timeline. Enable IND/NDA/BLA submission per aligned CMC timeline. 5)Serve as a key contributor to author and/or review regulatory dossier for IND/NDA/BLA submission and regulatory interaction materials. 6)Evaluation of new and breakthrough technologies. Application of theoretical engineering knowledge, to establish robust technical product requirements, and develop engineering design solutions to assure devices maintain the required level of performance throughout the life of the product. Qualifications: 1)PhD in pharmaceutical sciences, biochemistry, chemical engineering, or relevant field, with 0-2 years of experience in biological drug product development in the biopharmaceutical industry. Experience with prefilled syringe and/or pen- /autoinjector development is a plus. 2)Sound knowledge of legislation, regulation, industry ISO standards, and guidance within the area of combination products and medical device is a plus. 3)Demonstrable knowledge of drug delivery devices, parenteral drug delivery, risk assessment, design control, statistical analysis, drug delivery device assembly processes and human factor engineering 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. 校招项目-2026春招允许投递2次，请选择适合的职位进行投递 立即投递