雇員點評標簽
職位描述
液體制劑蛋白制劑注射制劑生物藥
Key Responsibilities
Strategic Leadership & Management:
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.
- 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.
- 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.
- 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.
- 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
寧波慈溪市康龍化成杭州灣園區(qū)
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職位發(fā)布者
徐女士/招聘經理
三日內活躍立即溝通
康龍化成康龍化成（北京）新藥技術股份有限公司（股票代碼：300759.SZ/ 3759.HK）是行業(yè)前沿的生命科學研發(fā)服務企業(yè)。自2003年成立以來，康龍化成一直致力于人才培養(yǎng)和設施建設，為包括小分子、大分子和細胞與基因治療藥物在內的多療法藥物研發(fā)打造了一個貫穿藥物發(fā)現(xiàn)、臨床前及臨床開發(fā)全流程的研發(fā)生產服務體系。康龍化成在中國、美國、英國均開展運營，擁有22,000多名員工，向北美、歐洲、日本和中國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系。（詳情請訪問公司網站：www.pharmaron.com）
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