CMC專案團隊主管/ CMC Project Team Lead

我們誠摯邀請具備豐富CMC經驗與卓越領導力的CMC專案團隊主管加入，主導抗體與ADC等生物藥物的藥物原料（DS）、製劑（DP）及製程開發的全程專案管理。此職位將負責領導跨部門團隊並管理國內外CDMO夥伴，確保從早期開發至後期與商業化階段的CMC工作順利執行。 此職位適合具備堅實技術背景與多年生物製劑CMC專案管理經驗之專業人才。 ________________________________________ 主要職責 • 擔任公司CMC專案負責人，主導跨部門團隊擬定策略與執行計畫，確保專案達成進度與品質目標。 • 協調製程開發、分析方法、製劑開發、品質、法規與製造等功能團隊之合作。 • 負責管理委外CDMO之藥物原料、製劑開發與製造事宜，包含技術轉移、放大與GMP生產。 • 規劃並落實CMC開發專案藍圖，包含重要里程碑、風險評估與資源配置。 • 提供CMC技術監督，並參與監管法規文件準備（IND/IMPD/BLA/MAA等）。 • 代表CMC部門參與公司核心專案團隊會議，並定期向高階主管簡報進度與挑戰。 • 支援與潛在合作夥伴的技術交流、盡職調查與聯盟管理等事宜。 ________________________________________ 工作地點： 台北市, 竹北市 資格條件 • 生物化學、藥學、化學工程等相關領域博士學位（Ph.D.）。 • 至少10年生物製劑CMC開發經驗（如單株抗體、ADC等），其中5年以上具專案領導經驗。 • 熟悉ICH、FDA、EMA等生物藥品相關法規與品質系統。 • 具備與CDMO或CRO合作管理經驗，並能有效領導跨部門團隊。 • 熟悉製劑開發、技術轉移、製程放大與GMP生產等流程者尤佳。 • 具備策略思維與良好執行力，能獨立推動專案並解決問題。 • 具備優秀的溝通能力與跨文化協作經驗。 • 英文流利尤佳。 Position Overview We are seeking a highly experienced and motivated CMC Project Team Lead to oversee the end-to-end development of drug substance (DS), drug product (DP), and associated CMC deliverables. This individual will lead internal cross-functional CMC teams and external CDMO projects to ensure project execution across all development phases—from early development through late-stage and commercial readiness. This role is ideal for a CMC expert with a strong technical background and demonstrated leadership in managing complex biologics development programs, including monoclonal antibodies and antibody-drug conjugates. ________________________________________ Key Responsibilities • Serve as the CMC project lead for TaiMed’s internal pipeline programs, accountable for strategy, timelines, and execution across all CMC functions. • Drive and coordinate cross-functional project teams (e.g., process development, analytical, formulation, manufacturing, regulatory). • Manage CDMOs to ensure deliverables for drug substance, drug product, and formulation development are met on time, within budget, and according to quality standards. • Translate development strategy into integrated CMC project plans with clear go/no-go criteria, milestones, and risk mitigation strategies. • Provide technical oversight for upstream/downstream processes, tech transfer, scale-up, GMP manufacturing, and regulatory submission support. • Collaborate closely with regulatory affairs to contribute to IND/IMPD/BLA/MAA documentation. • Act as the primary CMC representative in program core teams and communicate progress and issues to executive management. • Contribute to partner interactions, due diligence, and alliance management activities when relevant. ________________________________________ Location: Taipei or Zhubei, Taiwan Qualifications • Ph.D. in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline. • Minimum 10 years of experience in biologics CMC development (mAbs, fusion proteins, ADCs), with at least 5 years in a project leadership role. • Strong knowledge of regulatory requirements (ICH, FDA, EMA) and quality systems for biologics. • Proven experience managing CDMO/CROs and leading global cross-functional teams. • Hands-on expertise in product development, tech transfer, scale-up, and GMP manufacturing is highly desirable. • Demonstrated ability to develop and drive strategic plans and deliver on aggressive timelines. • Excellent communication, organizational, and stakeholder management skills. • Fluent in English.