上海招聘

Your role:
The Scientist will have scientific expertise in biologics safety testing focused on molecular biology. They will ensure projects are carried out with the appropriate scientific and regulatory compliance oversight. They will also provide their scientific expertise to support investigations and client meetings. The Scientist will have the technical expertise to advice and support GLP / GMP operations. Responsibilities include reviewing proposals, acting as study director/responsible scientist on complex technical projects, responding to routine assay enquiries, reviewing and monitoring assay performance and lead scientific trouble shooting discussions during investigations. They will maintain an in-depth understanding of Process Solution Services, BioReliance services and technical principles as well as advances in the field.
The ability to maintain effective working relationships with development services, commercial, SMEs from global PSS and laboratory personnel will be critical for success in the role.
The Scientist will be able to perform the following functions independently, with minimal guidance.
Who you are:
Brief role description:
· Lead new assay and technology transfer
· STUDY: Acts as a Study Director or Responsible Scientist for routine and complex assays and as such holds responsibility for the overall conduct of GLP or GMP studies, respectively
· Plans, organises and prioritizes workload ensure testing are conducted timely and effectively issuance of studies Certificate of Analysis (COA)
· Ensure routine and complex client studies are completed on time, to the appropriate scientific and regulatory standards
· Works with Lab Manager/Manager on testing schedule for laboratory personnel
· Works within the laboratory areas providing hands-on support, training, guidance, and mentorship to ( virology and detector cell culture) laboratory personnel
· Leads by example, acts as subject matter expert, offers scientific coaching and mentoring to other scientific laboratory personnel
· Author, Reviewer and Approval for study and other technical scientific documents, such as amendments, Scientific protocols, Standard Operating Procedures (SOPs), workbooks, technical specification
· Designs, directs and leads complex projects related to area of operational expertise
· Ensures trending spreadsheets are completed in a timely manner for all studies in accordance with relevant SOP
· Author and reviewer of assay risk assessments related to area of operational expertise
· Ensures all assays / processes are in a validated state in line with current regulations
· Responsible for maintenance and scientific integrity of routine and non-standard assays methods by monitoring assay performance and advising and implementing on improvements where necessary
· Leads process improvements within the laboratory to improve quality and performance
· Performs regular housekeeping laboratory check and Health and Safety audits
· Host internal Quality Audit representing the laboratory; participate in client or regulatory audit
· Responsible on audit observations response through the BioReliance Integrated Quality System (Trackwise)
· Lead and ensure deviation and Corrective or Preventative Action (CAPA) records in a timely manner
· Raise and progress Change Control for new service, testing, assay validation introduction
· Acts as scientific consultant to support departmental investigations, client product queries, supplier audits and client/regulatory inspections
· Liaises with Commercial, Development Services, Programme Management and other Laboratory Operations to provide technical support for ongoing and upcoming projects/studies, as required
· Acts as point of contact for routine study enquiries
· Works with Development Services to review proposals for projects
· Ensures a safe and healthy work environment at all times by not only complying with but actively embracing health and safety policies and procedures, ensuring the safety of yourself and others within the workplace
The above list of job duties is not exclusive or exhaustive and the post holder will be required to undertake such tasks as may reasonably be expected within the scope of the post. Job descriptions will be regularly reviewed to ensure they are an accurate representation of the post
Who you are:
Education:
· Master’s degree in Biological Sciences or relevant scientific subject.
Experience:
· Minimum 8 years of experience in a scientific laboratory role, ideally within a GLP / GMP contract testing laboratory environment
· Demonstrable scientific expertise in molecular biology related works
· Experience of working in Biosafety Level 2 laboratory

默克集团(Merck KGaA)创建于1668年，拥有约350年历史，总部位于德国达姆施塔特市(Darmstadt)，该集团主要致力于创新型制药、生命科学以及前沿功能材料技术， 并以技术为驱动力，为患者和客户创造价值。

截止2012年，默克在全球67个国家和地区拥有154个分支机构，以及38,000名员工。

在中国，默克主要从事制药、生命科学和化工业务，并为客户提供从创新型的处方类药品、非处方类药品到生命科学领域的解决方案，工业用途的效果颜料和化学品。默克的业务主要分为三大分支:默克医药健康业务分支、默克生命科学业务分支、高性能材料业务分支