南京招聘

· Serve as Technical Lead on manufacture of critical specialty products, including serving as technical lead / Person-In-Plant representing at Contract Manufacturing Organizations (CMOs)

· Ensure that any issues related to product or process technology are identified, a root cause analysis conducted, and corrective actions implemented to ensure resolution

· Maintain product robustness through continued process verification plan and periodic product reviews. Support ongoing product supply by ensuring robust and capable processes are in place and monitored.

· Support of product transfers from sites to a CMO, between CMOs or from CMOs to sites

· Impact assessment and support of changes including change control and risk assessment

· Ensure with Quality Assurance that necessary validation activities have been planned and executed to current standards (e.g. Product Lifecycle Management) in line with  QMS

· Lead technical risk assessment of new and existing products and facilities and identify/drive mitigation plans

· Apply OE tools and principals in the implementation of technical projects and improvement initiatives

· Support due diligence activities by providing technical assessment of potential new products/CMOs

· Work with multi-functional teams of Procurement, Quality, Technical, Supply, Project management, Strategy, Regulatory, Finance and Business Development professionals across the Global network.

· Provide leadership of key improvement initiatives with partner organizations on delivery of objectives

· Work to implement standards of quality by design into robust manufacturing operations

· Represent Technical at CMC Steering Team and New Product Supply Board as required

· Support mid-late phase portfolio projects and provide Pharma Supply Chain Technical input into design selection and manufacture considerations.

· Provide Pharma Supply Chain Technical input into developing product control strategy, author relevant sections of NDA/MAA, conduct OpTRA with contract manufacturers and ensure implementation of product control strategy on to shop floor/manufacturing operations.

· Agree and enforce all Technical standards related to the manufacture and supply of products by Contract Manufacturers, including new product introduction and validation of facilities, equipment and processes.

· BS in Chemical/Biochemical Engineering, Biochemistry, Chemistry or equivalent

· 10+ years experience in technical support of pharmaceutical manufacturing and/or process development

· Excellent verbal and written communication skills

· Ability to influence, lead and drive change

· Demonstrated record of achievement, including ability to work effectively in cross-functional teams

· Broad and integrated knowledge and experience that can impact project and team direction

· Working knowledge of regulatory requirements in the industry and drug development

· Ability to manage across multiple projects simultaneously, lead matrix teams, and mentor site based technical staff members

· MS or PhD Chemical/Biochemical Engineering, Biochemistry, Chemistry or equivalent

· Experience in technical support of commercial products, program management, technology transfer to commercial manufacturing sites (internal and to external CMO)

· Experience in process validation, regulatory file preparation, PAI support

· Agile decision-making – using evidence and applying judgement to balance pace, rigour and risk

· Managing individual and team performance.

· Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

· Implementing change initiatives and leading change.

· Sustaining energy and well-being, building resilience in teams.

· Continuously looking for opportunities to learn, build skills and share learning both internally and externally.

· Developing people and building a talent pipeline.

· Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.

· Building trust and collaboration, maintaining strong stakeholder relationships internally and externally.

· Budgeting and forecasting, commercial and financial acumen. 

  Changshu Tonghe Human Resource Service Company (Tonghe Headhunting) is a legally registered and private-owned company with business in Human Resource Consulting & Service area. Established in 2004, with more than 10 years development in Changshu City, now it is a locally well-known headhunting company in Suzhou city. As a local headhunting company, Tonghe Headhunting has successfully supplied good qualified candidates for most of the Foreign Invested Companies in the Yangtze River Delta Area through its professional and practical operation. Due to its efficiency & effective work & consistence in candidates sourcing, Tonghe Headhunting has already set long-term relationship with many well-known multinational companies, such as Novartis of Switzerland, Dowcorning of USA, UPM of Finland, Continental Of German & Danieli of Italy etc. Tonghe Headhunting has been successfully elected as the Vise-Chairman of the Changshu Human Resource Service Association ever since 2011. Within HR circle in Changshu & Yangtze River Delta Area manufacturing fields, Tonghe Headhunting enjoys very good reputation and inflection.
 
  常熟市通和人力资源服务有限公司是经合法登记注册的民营股份制人力资源咨询和服务机构。通和公司成立于2004年初，经过十多年的快速发展，目前已是苏州地区知名的人才猎头公司。 通和公司通过其专业而务实的服务已经成功地为在苏州及长三角地区投资的知名外资企业和大型民营企业提供了众多的优秀人才。 由于在人才招聘方面的高效，准确和持续搜寻能力，通和公司和许多知名外企建立了良好而长期的合作关系。迄今为止，通和公司已经为瑞士诺华制药公司，美国的道康宁公司，芬兰的芬欧汇川纸业，德国的大陆汽车及意大利的达涅利公司等众多知名企业提供了卓有成效的人力资源服务。自2011年起通和公司被评选为常熟市人力资源协会副会长单位。 在当地的人力资源行业及长三角的制造业内通和公司享有良好的声誉和影响力。

Our Mission
    To be a good supplier in HR integrated Service Area.
    To be the friend & consultant for the Professional Talent and High-Level Manager.

我们的使命（ Our Mission ）
    人力资源综合事务的优秀供应商
    高级管理和技术人才职业顾问和益友
  
Our Vision
    Be the influential headhunting company in the manufacturing fields with focus on Chemical & Pharmaceutical & Auto & mechanical.
    Be the well-known human resource supplier in Yangtze River Delta Area in the future.
 
我们的远景（ Our Vision ）
    制造业内知名的专业猎头公司（主要涵盖化工、医药、汽车、机械）
    成为长三角地区知名的人力资源供应商