給与 & 勤務地
待遇面談
（給与条件は常に4万台湾ドル以上）
台北市南港區
条件要件
職務経験
2年以上
職務内容
1. Formulation Development:
• Design/Develop and optimize Drug Substance/Drug Product formulations for dosage forms (injectables) of large molecule (mAbs, ADC, …etc.).
• Conduct studies and assess the impact of formulation changes on product CQAs.
2. Process Development:
• Design and execute process development studies of DS/DP formulations from the lab-scale to CDMO production.
• Evaluate manufacturing processes and recommend improvements to enhance efficiency and product quality.
3. Documentation and Compliance:
• Support regulatory submissions, including INDs and NDAs/BLAs, ensuring compliance with regulatory guidance.
• Maintain accurate and thorough documentation of all research and development activities.
4. Cross-Functional Collaboration:
• Work closely with colleagues in Analytical, Biology, Clinical, Regulatory, and Quality Assurance to support product development initiatives.
• Participate in project teams, contributing scientific expertise to drive successful outcomes.
5. Troubleshooting:
• Investigate and resolve formulation and manufacturing issues, applying scientific principles to develop effective solutions.
応募者数
1~1人
学歴要件
專科以上
専攻要件
生物學相關、醫藥工程相關、化學工程相關
勤務時間
日班
休暇制度
依公司規定
スキル要件
Chemical Process Research and Development
Process Related Technology Development
化學製程研發 製程相關技術開發
職種カテゴリ
Chemical Engineering Research and Development Staff
Industrial Engineer / Production Line Planning
Production Technology / Process Engineer
台北市南港區
生化科技研發業
台灣浩鼎 (OBI Pharma Inc.) 是一已推進至臨床階段的全球性癌症新藥公司，除設於台灣之企業總部及研發中心外，在美國和澳洲均有子公司。它是由美國知名的成功生技創業家張念慈博士 (Dr. Michael Chang) 於2002年所創立，2012年公開發行，2015年在台北櫃買中心正式上櫃交易 (TWO.4174)。
台灣浩鼎專注於癌症療法的創新與研發，旨在開發首創型 (first-in-class) 及同類最佳(best-in-class) 的突破型新藥，希望以「台灣製造」品牌，行銷全世界，並為醫療需求尚未被滿足的患者，提供新的治療選擇。
OBI 核心價值，除了極具前景的 Globo 系列 (如 Globo H) 癌症治療疫苗外，更聚焦於提供患者一系列獨特的抗體藥物複合體 (ADC) 新藥。 這些不斷擴展的產品組合，包括以TROP2、Nectin4、HER2 等一系列癌症標靶所開發的 ADC 產品。它們均以浩鼎獨家開發的兩個 ADC 技術平台所構建。兩個平台各具特色，都可「量身訂製」各種ADC；透過抗體醣位點的修飾，可精準將小分子藥物鏈接，憑藉此「即插即用」的策略及平台放大生產之潛力，使得 ADC 開發相對簡單而有效率。
OBI 正致力於將其擁有的 ADC 技術平台商業化，並期待與生技和製藥公司合作，實現首創型 (first-in-class) 和同類最佳 (best-in-class) 候選藥物的進一步開發。
OBI Pharma Inc. (OBI) is a global clinical stage oncology company that is headquartered in Taiwan. The company also has subsidiaries in the United States and Australia. It was founded in 2002 by Dr. Michael Chang, an accomplished biotech entrepreneur in the United States. Its stocks were issued publicly in 2012. Subsequently, the company was successfully listed on the Taipei Exchange (TWO. 4174) in 2015.
OBI focuses on innovative research and development for cancer therapies and aims to develop “first-in-class” and “best-in-class” ground-breaking drugs. It aspires to market these drugs worldwide with a “Made in Taiwan” branding and to provide new treatment options for patients with unmet medical needs.
The core value of OBI lies in its passion to develop and deliver a portfolio of unique antibody-drug conjugates (ADC) drugs for patients, in addition to its promising Globo series (e.g., Globo H) of cancer therapeutic vaccines. This evolving portfolio includes a spectrum of cancer targets, such as TROP2, Nectin4, HER2, etc. These ADCs are built based on two distinct ADC technology platforms, each with different characteristics. Both platforms are customizable and offer a “plug-and-play” advantage through a specialized site-specific conjugation using a proprietary enzyme. With the added value of scalability, these “plug-and-play” technology platforms enable ADC development to be relatively simple and efficient.
OBI is interested in commercializing its ADC technology platforms and looks forward to collaborating with biotech and pharmaceutical companies by enabling “first-in-class” and “best-in-class” therapeutic candidates for further development.
