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(Associate) Director, Formulation Development

3-4萬(wàn)
  • 寧波慈溪市
  • 10年以上
  • 碩士
  • 全職
  • 招1人

雇員點(diǎn)評(píng)標(biāo)簽

  • 同事很nice
  • 工作環(huán)境好
  • 免費(fèi)班車(chē)
  • 人際關(guān)系好
  • 團(tuán)隊(duì)執(zhí)行強(qiáng)
  • 氛圍活躍
  • 交通便利
  • 管理人性化

職位描述

液體制劑蛋白制劑注射制劑生物藥
Key Responsibilities
Strategic Leadership & Management:
  • Provide strategic direction and day-to-day leadership to the Formulation Development team, fostering a culture of innovation, quality, and accountability.
  • Develop and manage the department’s resource allocation and maximize people’s work efficiency and the team’s project handling capability and capacity.
  • Mentor and develop top scientific talent, ensuring high levels of engagement and performance.
  • Define and implement best practices, workflows, knowledge management and long-term scientific strategies.
Technical & Scientific Excellence:
  • Oversee the design and execution of comprehensive formulation development programs for complex biologics, including mAbs, multispecifics, and novel modalities.
  • Champion the development of high-concentration liquid formulations, addressing key challenges of viscosity, stability, and manufacturability.
  • Drive the development, optimization, and scale-up of lyophilization processes for parenteral products.
  • Lead activities for drug products in pre-filled syringes and other delivery systems, including compatibility and process studies.
  • Spearhead drug developability and stability assessment, and biophysical characterization strategies to de-risk candidate molecules and guide formulation design.
  • Assist successful technology transfer of drug product processes to GMP production
  • Act as the ultimate scientific authority, reviewing and approving technical protocols, reports, and regulatory submissions.
Cross-Functional Collaboration & Compliance:
  • Serve as the primary subject matter expert (SME) for drug product development on client projects and internal governance teams.
  • Collaborate seamlessly with Analytical Development, Process Development, Manufacturing Science and Technology, Quality, and Manufacturing teams to ensure integrated project execution.
  • Ensure GMP/registration related activities are performed in compliance with all relevant regulatory requirements (NMPA, FDA, EMA, etc.).
  • Represent the department during client audits and help regulatory inspections.
Qualifications & Experience Essential:
  • PhD in Pharmaceutics, Biochemistry, Chemical Engineering, or a related field with 5+ years of industry experience, OR a Master's degree with 8+ years of proven experience.
  • Extensive, hands-on expertise in biologics formulation development, with a deep mastery of:
  • High-concentration liquid protein formulations.
  • Lyophilization development and scale-up.
  • Drug product development for pre-filled syringes.
  • A wide range of biophysical characterization techniques (e.g., DSC, DLS, CD, MFI).
  • Process characterization
  • A minimum of 3 years of direct line management and technical leadership experience, with a proven ability to lead, motivate, and develop a high-performing team.
  • Comprehensive understanding of GMP requirements for clinical and commercial drug product manufacturing.
  • Direct experience with tech transfer to fill/finish operations.
  • Fluent English with exceptional written and verbal communication skills, demonstrated by a history of authoring technical and regulatory documents and effectively engaging with clients.
Desirable:
  • Prior experience within a CDMO or contract research environment.
  • Experience interacting with health authorities and supporting regulatory filings (IND/IMPD/BLA).
  • Strong business acumen and client relationship management skills.

工作地點(diǎn)

寧波慈溪市康龍化成杭州灣園區(qū)

職位發(fā)布者

徐女士/招聘經(jīng)理

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康龍化成（北京）新藥技術(shù)股份有限公司（股票代碼：300759.SZ/ 3759.HK）是國(guó)際領(lǐng)先的生命科學(xué)研發(fā)服務(wù)企業(yè)。自2003年成立以來(lái)，康龍化成一直致力于人才培養(yǎng)和設(shè)施建設(shè)，為包括小分子、大分子和細(xì)胞與基因治療藥物在內(nèi)的多療法藥物研發(fā)打造了一個(gè)貫穿藥物發(fā)現(xiàn)、臨床前及臨床開(kāi)發(fā)全流程的研發(fā)生產(chǎn)服務(wù)體系?？谍埢稍谥袊?guó)、美國(guó)、英國(guó)均開(kāi)展運(yùn)營(yíng)，擁有22,000多名員工，向北美、歐洲、日本和中國(guó)的合作伙伴提供研發(fā)解決方案并與之保持良好的合作關(guān)系。（詳情請(qǐng)?jiān)L問(wèn)公司網(wǎng)站：www.pharmaron.com）
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