Talent.com
工艺开发研究员 — 恒瑞-全球精英计划
工艺开发研究员 — 恒瑞-全球精英计划Hengrui Pharma • Princeton, NJ, United States
工艺开发研究员 — 恒瑞-全球精英计划

工艺开发研究员 — 恒瑞-全球精英计划

Hengrui Pharma • Princeton, NJ, United States
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

工作地点：上海

岗位职责 :

  • 负责生物药（单抗、双抗、融合蛋白等）上游 / 下游工艺开发与优化，包括但不限于细胞培养、纯化工艺开发。
  • 负责新型工艺平台的开发与探索，包括连续生产、高密度培养、PAT技术等
  • 参与工艺技术转移（Tech Transfer），并提供放大生产支持。
  • 负责起草相关技术文档，支持IND / BLA申报。
  • 遵循GLP（良好实验室规范）要求开展实验方案制定、数据记录与分析，确保研发过程的可追溯性和合规性。
  • 参与实验室日常5S运营与维护。

任职要求：

  • 硕士及以上学历，生物工程、生物技术、化学工程、制药工程或相关专业。
  • 具有哺乳动物细胞培养或蛋白纯化操作经验优先。
  • 熟悉DoE（实验设计）等统计工具，具备工艺建模及数据分析能力（JMP / Minitab等）。
  • 了解国内外生物药相关法规（ICH / USP / EP）及行业指导原则（如QbD理念）。
  • 具有较强的文献检索，分析和问题解决能力。
  • 具有良好团队协作精神和跨部门沟通能力。

    • Responsibilities :

  • Responsible for upstream / downstream biopharmaceutical process development and optimization (including but not limited to cell culture and purification processes) for monoclonal antibodies, bispecific antibodies, fusion proteins, etc.
  • Explore and develop novel process platforms, including continuous processing, high-density cell culture, and Process Analytical Technology (PAT).
  • Participate in process technology transfer (Tech Transfer) and provide scale-up manufacturing support.
  • Prepare relevant technical documents to support IND / BLA filings.
  • Conduct experiments in compliance with GLP (Good Laboratory Practice) requirements, ensuring traceability and regulatory compliance in R&D processes.
  • Participate in laboratory 5S operations and maintenance.

    • Requirements :

  • Master’s degree or higher in Bioengineering, Biotechnology, Chemical Engingeering, Pharmaceutical Engineering, or related fields.
  • Hands-on experience in mammalian cell culture or protein purification is preferred.
  • Familiarity with statistical tools such as DoE (Design of Experiments) and proficiency in process modeling and data analysis (JMP, Minitab, etc.).
  • Knowledge of global biopharmaceutical regulations (ICH, USP, EP) and industry guidelines (e.g., QbD principles).
  • Excellent literature search capabilities coupled with analytical thinking and problem-solving skills
  • Excellent teamwork and cross-functional communication abilities.
    • serp_jobs.job_alerts.create_a_job

    工艺开发研究员 — 恒瑞-全球精英计划 • Princeton, NJ, United States

    Job_description.internal_linking.related_jobs
    制剂研究员 — 恒瑞-全球精英计划

    制剂研究员 — 恒瑞-全球精英计划

    Hengrui Pharma • Princeton, NJ, United States
    serp_jobs.job_card.full_time
    Responsible for formulation-related activities throughout the full lifecycle of biologics, spanning pre-IND application, early clinical phases, pivotal clinical phases, and post-marketing stages.Co...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    生产管培生— 恒瑞-全球精英计划

    生产管培生— 恒瑞-全球精英计划

    Hengrui Pharma • Princeton, NJ, United States
    serp_jobs.job_card.full_time
    GMP合规落实，负责工艺文件更新、验证管理、偏差管理及应对国内外认证核查.FDA / EMA / WHO / ICH / NMPA的法规动态，负责法规新政策的解读、翻译、培训及落地 6.Participate in the full process of technology transfer from R&D to production, review technology transfer report...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Product Engineering (Prod Dev)

    Product Engineering (Prod Dev)

    1014 AD Federal • Alpha, MA, United States
    serp_jobs.job_card.permanent
    NASDAQ : ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologie...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Manufacturing Engineering

    Manufacturing Engineering

    1014 AD Federal • Alpha, MA, United States
    serp_jobs.job_card.permanent
    NASDAQ : ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologie...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Expert, Gene Therapy Analytical Development Chemistry

    Senior Expert, Gene Therapy Analytical Development Chemistry

    Novartis Group Companies • East Hanover, NJ, United States
    serp_jobs.job_card.full_time
    As a key member of the Analytical Development team, this individual will support developmental activities to aid in delivering gene therapy to patients. The successful candidate will support technic...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Manager, Business Development, Cell & Gene Therapies

    Senior Manager, Business Development, Cell & Gene Therapies

    Fresenius Kabi USA, LLC • Newark, NJ, United States
    serp_jobs.job_card.full_time
    The Senior Manager, Business Development, will play a critical role in driving global sales and business development strategy for our cutting-edge Cell and Gene Therapies (CGT) Technologies divisio...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    转化科学主管 — 恒瑞-全球精英计划

    转化科学主管 — 恒瑞-全球精英计划

    Hengrui Pharma • Princeton, NJ, United States
    serp_jobs.job_card.full_time
    Disease Area Expertise & Target Assessment.Conduct in-depth biological assessments of therapeutic targets across disease areas (including oncology, immuno-oncology, autoimmune diseases, metabolic d...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Alliance Management Specialist — 恒瑞-全球精英计划

    Alliance Management Specialist — 恒瑞-全球精英计划

    Hengrui USA • Princeton, NJ, United States
    serp_jobs.job_card.full_time
    Support the management of strategic alliances by coordinating activities across assigned partnerships and providing assistance on priority partnerships. Coordinate collaborative initiatives (e.Track...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Clinical Trial Manager

    Senior Clinical Trial Manager

    VirtualVocations • Elizabeth, New Jersey, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Clinical Trial Manager to lead the operational delivery of cell therapy clinical trials. Key Responsibilities Lead and manage the operational execution of assigne...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Radioligand Therapies (RLT) Director, Ecosystem Lead - East

    Radioligand Therapies (RLT) Director, Ecosystem Lead - East

    Novartis Group Companies • East Hanover, NJ, United States
    serp_jobs.job_card.full_time
    This is a field-based and remote opportunity supporting key accounts in the eastern United States which will include : New York, Nashville, Charlotte, Atlanta, Miami, Chicago and the surrounding ar...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Account Executive - Cell & Gene Therapies

    Account Executive - Cell & Gene Therapies

    Fresenius Kabi USA, LLC • Newark, NJ, United States
    serp_jobs.job_card.full_time
    The Account Executive, Cell & Gene Therapies (CGT), is responsible for driving strategic sales growth and market penetration of Fresenius Kabi's CGT technologies across the U.This role builds and m...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Radioligand Therapies (RLT) Director, Ecosystem Lead - Northern CA

    Radioligand Therapies (RLT) Director, Ecosystem Lead - Northern CA

    Novartis Group Companies • East Hanover, NJ, United States
    serp_jobs.job_card.full_time
    This is a field-based and remote opportunity supporting key accounts in an assigned geography.Novartis is unable to offer relocation support for this role. Please only apply if this location is acce...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    ED, Decision Science Product Lead - CV

    ED, Decision Science Product Lead - CV

    Novartis Group Companies • East Hanover, NJ, United States
    serp_jobs.job_card.full_time
    The ideal location for this role is East Hanover, NJ but a distant working arrangement may be possible in certain states. Distant workers are responsible.East Hanover, NJ, as determined necessary by...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Global CX Function Lead

    Global CX Function Lead

    VirtualVocations • Hamilton, New Jersey, United States
    serp_jobs.job_card.full_time
    A company is looking for a CX Global Function Lead, Business.Key Responsibilities : Oversee day-to-day CX operations and ensure alignment with team goals Provide guidance to Regional POD Owners a...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Technical Research Lead

    Technical Research Lead

    VirtualVocations • Elizabeth, New Jersey, United States
    serp_jobs.job_card.full_time
    A company is looking for a Technical Research Lead responsible for enhancing research and integrity processes in food systems. Key Responsibilities Oversee and improve key research processes, ensu...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Expert Science & Technology, Potency, Analytical Development

    Senior Expert Science & Technology, Potency, Analytical Development

    Novartis Group Companies • East Hanover, NJ, United States
    serp_jobs.job_card.full_time
    This position will be located at East Hanover, NJ site and will not have the ability to be located remotely.Internal Title : Senior Expert Science & Technology. Bench to bedside! This exciting role s...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Director of Drug Development

    Senior Director of Drug Development

    VirtualVocations • Hamilton, New Jersey, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Director, Drug Product Development (Remote / Home Based).Key Responsibilities Directs the Small Molecule Drug Product Development team and manages budgetary resp...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Executive Director - Decision Science, Product Lead - Immunology

    Executive Director - Decision Science, Product Lead - Immunology

    Novartis Group Companies • East Hanover, NJ, United States
    serp_jobs.job_card.full_time
    The ideal location for this role is East Hanover, NJ but a distant working arrangement may be possible in certain states. Distant workers are responsible.East Hanover, NJ, as determined necessary by...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted