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CDMOhead

0-200万元/年

上海市博士及以上

刷新时间:7天前

职位描述


Business Unit
CDMO [Contract Development and Manufacturing Organization]

Position of Function
Head of CDMO, Member of Senior Leadership Team

Reporting To
CEO

Job Band
Senior Director/Vice President, 16/17

Position based at
Shanghai, China

Years of Experience A minimum 10 years of relevant Engineering or Life Sciences work experience in biopharmaceutical industry. Must have direct Bioprocess development (PD) experience of biologics including cGMP manufacturing material for early phase clinical trials at pilot scale. Must be familiar with theraputic prtoteins such as monoclonal antibodies. Technical Operations and Quality Operations experience are highly desirable.

Education Qualification & Experience
Ph.D. in relevant Life Sciences, Bioengineering or Biochemical Engineering, Biomolecular Engineering.

Key Responsibilities


Lead, direct and manage CDMO Department composed of Process Development, Pilot Plant, Process Validation, Technical Support (with labs), and Project Management based on business goals:
• Deliver material made in Pilot Plant required for IND submission and prepare CMC documents for IND submissions in China, other emerging and regulated markets.
• Direct and lead manufacturing plant operations, including developing capacity and capability model design for strategic growth
• Assist business development in project evaluation and provide technical inputs to potential projects
• Conduct COGs analysis of commercial products and provide answers to what-if’ questions to guide process and plant design
• Perform process improvement, optimization studies to improve process yield and productivity
• Provide directions and technical inputs of early phase projects including tech transfers, risk assessment and process adaptation
• Design Process Validation protocol and master plan based on PD inputs with fully defined CPPs and CQAs. Then assist Manufacturing group to execute PV runs.
• Prepare and manage/monitor department budget [OPEX and CAPEX]
• Manage manpower resources of the departments via FTE planning
• Develop comprehensive yet flexible plan for full capacity operations to meet market demand
• Recruit aggressively and build trained manpower and manage resources flexibly to achieve business goals
• Work seamlessly with functions including QA, QC, RA, BD, Marketing and Sales, etc. to establish customer satisfaction culture for achieving business goals.



Desired Skills/Competencies

• Proven leadership skills and track records of success in similar leadership roles
• Excellent verbal and writing communication skills
• Demonstrated creative problem-solving skills under resource constraints and time pressure
• Strong technical problem-solving abilities with innovative approaches
• Demonstrated leadership skills in coaching, managing and mentoring new staff members
• Demonstrated ability to lead changes under constraints and stress
• Deep understanding of quality system and cGMP guidelines
• In-depth knowledge of technical processes and analytics of product development and manufacturing
• Knowledge on biologics / biotech
• Knowledge of regulatory framework
• • Fluent in both English and Mandarin
Operating Network
Production Planning, BD, SCM, QC, QA, BD, PM, Engineering, Facilities, Commercial, Product Development, Corporate Staff functions (HR, Finance)

其他要求

  • 1人
  • 总经理
  • 销售总监/副总

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业,总部位于杭州,下属有上海、南京、广州、武汉等多家分公司,同时自主开发国内领先的猎头办公系统及医药人才网站,全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台,在欧、美、日等国家建立了海归引进平台,同时积极开展医药高等院校公益系列讲座,搭建了以人力、企业为主体的立体化咨询服务网,为医药企业人才队伍建设发挥了积极重要作用,为很多医药企业解决了高端人力之困。

所在城市:
所任职位:
BP

企业信息

名称:
诗迈医药猎头
行业:
制药.生物
性质:
私营/民营企业
规模:
1-49人

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