臺灣生物醫藥製造股份有限公司

Principle Roles & Responsibilities 1.物理及化學分析設備的規格書撰寫,採購,驗證及操作文件撰寫 2.物理及化學分析實驗室管理及相關管理SOP撰寫 3.原料/生產產品檢驗相關分析方法的技轉,確效,及操作SOP撰寫及執行 4.參與物理及化學分析實驗室操作人員在職訓練 5.制定並執行穩定性測試計劃，以及分析方法的驗證與確效。 6.評估穩定性趨勢與分析數據。 7.負責物理和化學分析相關設備的校準與預防性維護活動。 8.審核所有物理和化學測試的檢測結果。 9.解決原料、成品、生產過程研究及驗證中的物理與化學測試問題，進行故障排除和解決。 10.向實驗室主管或代理人報告設備故障及安排維修 11.負責實驗室試劑和消耗品的充足庫存，透過監控再訂購水平並及時通知。 12.負責準確的記錄分析數據與結果於記錄本、產品規格與品質保證報告，以及實驗室分析表單，並以趨勢監測的角度記錄結果。 13.負責調查物理與化學實驗室的超出規格（OOS）與偏差事件。 14.以持續改進的態度執行工作，以達成既定的關鍵績效指標（KPI）。 15.完成主管或公司指派的其他任務。 Secondary Responsibilities 1.協助準備分析所需的試劑，並按照標準書面方法，在規定的時間間隔內對容量分析溶液進行標定。 2.參與產品、原料、包裝材料及穩定性樣品物理與化學相關分析。 3.協助分析人員執行實驗室設備的校準與預防性維護活動。 4.參與分析方法技轉程序。 5.負責確認內部開發的分析試劑的有效期限，並確認在其容器或文件上有標註到期日。 6.根據標準安全規範處理和處置危險材料，如砷、氰化物和濃酸。 7.按照標準預定程序，記錄受管制的有毒化學品的使用與處置情況。

此職務為製程開發與執行CDMO專案的重要核心角色，不僅需帶領團隊進行製程優化與放大，同時也需親自參與操作與執行，確保毒理批次 (Tox material) 生產與技術轉移 (Tech Transfer) 的品質與時效。此角色同時涵蓋 MSAT (Manufacturing Science and Technology) 的功能，需兼具團隊領導、專案規劃與實際操作能力，確保製程具備穩健性並能順利導入 GMP 環境。 1) Team and Process Management - Lead a team in executing upstream process operations from 5 to 200 liters (and potentially larger). - Remain hands-on in process execution, ensuring consistency, scalability, and reproducibility. 2) Tox Material Production - Personally perform and supervise non-GMP Tox batch production to support preclinical studies. - Ensure high-quality material delivery that meets project timelines. 3) Process Optimization and DOE - Design and directly participate in experiments (DOE) for process optimization. - Drive improvements in yield, efficiency, and robustness in collaboration with the team. 4) Tech Transfer and CDMO Interface - Lead the preparation and execution of technology transfer packages. - Remain actively involved in technical execution and troubleshooting during CDMO interactions. 5) Cross-Functional Collaboration - Collaborate with downstream and analytical teams to ensure end-to-end project success. 6) Clearly communicate process outcomes and project updates through reports and presentations. - Team Training and Development - Mentor and train junior staff while also serving as a technical role model through hands-on execution.

1.負責病毒載體製程開發與優化 2.操作生物反應器放大生產 3.負責計畫整理與執行管理 4.開發新穎製程技術

1. 負責ADC藥物製程開發及純化 2. 有機合成實驗操作、化合物純化及鑑定 3. 執行固相合成實驗及製程開發 4. 具備光譜分析和文獻查詢能力 5. 協助實驗室事務

1. 細胞治療技術研發與生產團隊之營運管理，確保製程研發、品管、GMP 生產之品質，符合客戶與法規需求 2. 與國內、國外細胞與基因治療公司，建議良好的溝通管道與信任關係 3. 細胞治療製程開發實驗室之管理與營運，確保研發與檢測品質 4. 細胞治療產品 GMP工廠生產製造管理，確保細胞產品生產符合法規與臨床要求 5. 客戶拜訪、接洽，並完成服務案件之簽約。進度與交付事項管理，確保依規劃允收完成 6. 與醫學中心建立合作關係，維持良好的組織來源管道，以建置 TBMC 高品質組織細胞來源與細胞生產種源原料庫建置 7. 持續規劃技術研發，以降低細胞產品成本。例如: 自動化生產的導入，提升生產效率並降低人力成本

1) 分析方法開發與驗證(Analytical Method Development & Qualification) • 方法開發與應用： 針對核酸藥物, 基因治療和生物製劑產品，開發並應用多種細胞培養技術的分析方法，包括但不限於： • dPCR/qPCR： 用於檢測和定量特定核酸序列。 • ELISA： 用於檢測和定量蛋白質或抗體。 • 流式細胞術： 用於細胞表面標記物分析、細胞週期分析及細胞凋亡檢測。 • 功能性測試： 評估產品的生物活性或細胞反應。 • NGS (次世代定序)： 運用 NGS 技術進行更深入的基因體、轉錄體分析。 • 方法優化與驗證： 對開發的分析方法進行嚴謹的優化，以確保其準確性 (accuracy)、特異性 (specificity)、再現性 (reproducibility) 和穩定性 (stability)。 • 法規文件撰寫： 根據國際藥政法規（如 ICH、USP、FDA、EMA 等）的要求，撰寫詳細的方法開發報告 (Method Development Reports) 和方法驗證報告 (Method Qualification Reports)。 2) 細胞培養技術應用 (Cell Culture Techniques Application) • 培養並維持哺乳動物細胞，以進行細胞功能測試及藥效分析，包含操作P2等級病毒。 Maintain and monitor mammalian cell cultures, ensuring optimal growth conditions for functional assays, including handling P2 level viruses. • 監測細胞生長動態，調控培養條件，確保細胞健康度與試驗數據可靠性。Adjust culture conditions and monitor cell viability to ensure reliable test results. • 針對不同基因治療載體或 mRNA 藥物，建立適用的細胞模式，需具備P2實驗室操作經驗。 Establish cell-based assays to evaluate gene therapy vectors and mRNA drug candidates, requiring P2 laboratory operational experience. 3) 藥物開發支援 (Support for Drug Development) • 協助評估 基因治療與 mRNA 疫苗的效能、安全性與品質，提供開發與生產階段的分析數據。Assess the potency, safety, and quality of gene therapy and mRNA vaccine products. • 參與跨部門協作 (Cross-functional collaboration)，與 CMC、製程開發、生產 (Manufacturing) 等部門合作，提供分析方法技術支持。Collaborate with CMC, Process Development, and Manufacturing teams to provide analytical support. 進行技術轉移，將已開發的分析方法移轉至 QC (Quality Control) 或生產端。Facilitate technology transfer (Tech Transfer) of developed methods to QC and production departments.

1. 有機合成實驗操作、化合物純化及鑑定。 2. 執行固相合成實驗及製程開發。 3. 具備光譜分析和文獻查詢能力。 4. 協助實驗室事務

The BD Head will be responsible for driving growth and expanding the commercial footprint of our Contract Research, Development and Manufacturing Organization (CRDMO) sectors, including cell therapy, gene therapy, and advanced biologics. This executive will lead global business development strategy, build and manage client relationships across the above biopharmaceutical sectors, and secure new partnerships in research/discovery, development, and clinical/commercial manufacturing. The executive will work closely with other TBMC executive leadership, operations, and program management to ensure that client needs are met with world-class solutions in order to secure TBMC’s leadership position in a competitive global market. 1. Strategic Leadership in Business Development & Market Expansion: • Develop and execute global BD strategies to achieve revenue and growth targets and market entry. • Identify new market opportunities, service expansions, and strategic partnerships with biotech and pharma clients worldwide, especially in North America, Asia-Pacific (focus on Taiwan, Japan and China) and Europe. • Collaborate with marketing team to provide competitive market intelligence and shape offerings to align with industry trends. 2. Business Development Management: • Lead client acquisition across the TBMC-served biopharma segments. • Own the sales pipeline: from lead generation through contract negotiation and closing. • Negotiate complex contracts, including master service agreements (MSAs), development and manufacturing agreements, and long-term supply deals. • Manage sale activities through CRM to penetrate new and expand the existing market segment. • Collaborate with marketing team to enable marketing initiatives, including brand positioning, thought leadership, and industry conference presence. • Prepare and deliver high-quality sales pitches, proposals, and business presentations. • Support CEO in high-level negotiations and strategic initiatives. 3. Client Engagement and Alliance Management: • Serve as a trusted advisor to TBMC leaders in partner organizations. • Collaborate with internal teams (R&D, Manufacturing, QA, PM, CMC, Legal) to ensure seamless client onboarding, project execution, and satisfaction. Understand client needs and deliver most desired CRDMO solutions. • Serve as the relationship owner and trusted advisor for key client accounts, from contract execution through the lifecycle of the partnership. • Lead or support CEO for strategic partnership activities with suppliers or service partners, and M&A activities as needed. 4. Cross-Functional Collaboration: • Partner with technical operations, R&D, and program management to translate client needs into executable solutions. • Provide commercial input into capacity planning, capital investments, and service portfolio decisions. 5. Leadership & Team Development: • Build, mentor, and lead a global business development team. • Establish KPIs and accountability mechanisms to measure success. • Promote TBMC culture and core values to engage BD staffs.