上海市 | 1人
The WuXi AppTec bioanalysis business for small and large molecules have been well established for many years – they are the preferred partner for many businesses in China. In 2014 WuXi AppTec acquired XenoBiotic Laboratories* in the US making their capabilities global and thus fulfilling part of an ongoing key strategic objective of WuXi AppTec Senior Leadership to enhance the company image globally. GLP bioanalytical laboratory operations comprise c.600 staff based in China (Shanghai and Suzhou) and the US (New Jersey).
In line with current industry trends WuXi AppTec Bioanalytical Services (BAS) are experiencing exponential growth in demand for Large Molecule Bioanalytical Services (BAS) both in China and the US.
It is an operational head position with responsibility for providing both high level client engagement and, high level leadership. The senior status of the position recognizes both the scientific focus of the position and the responsibility of interacting with the QA team, not only on the study conduct, quality, but also group operation.
JOB DESCRIPTION
Key responsibilities:
• Lead a team of Bioanalytical scientists in immunoassay area to provide GLP-compliant service to world-class pharma and biopharma.
• Effectively communicate and interface with business partners, internal Quality Assurance Unit and external regulatory authorities in order to fully comply with GLP and other pertinent regulations.
• Conduct external presentations and business development initiatives, and serve as a technical liaison to engage and onboard domestic and international clients.
• Establish and maintain business relationship with worldwide companies. Develop and maintain high level of scientific achievements for the company. Be expected to be point of contact for project coordination, including email and video/tele- conference with customers.
• Serve as an internal expert to design, develop and validate assays to measure biological drugs, their targets, or anti-drug antibody (ADA), neutralizing antibody (Nab) in biological fluidic samples from pre-clinical and clinical studies
• Prepare, review or approve assay validation and bioanalytical reports and present data to clients
• Provide training and mentorship to internal staffs
Qualifications:
Education and Experience required
Essential:
• Ph.D. in pharmaceutical sciences, immunology, biology or a related field
• A minimum of 2 years of industrial experience in CROs and/or pharmaceutical companies
• A minimum of 3 years direct experience in large molecules bioanalysis in support of preclinical and/or clinical PK/TK/PD, ADA, and vaccine studies
• Strong understanding of large molecules bioanalysis technologies and GLP/GCP/GCLP
• Familiar with pharmaceutical R&D process and GLP laboratory operations
• Demonstrated capability and confidence to build, train and lead a group
• Experience of directly managing a group of at least 5 staff
• Strong interest and demonstrated skills with state-of-art equipment such as Gyros, Luminex, MSD, Biacore, FACS, PCR, Luminescence, HTRF, etc.
• Fluent in both English and Mandarin, written and oral presentation skills
• Overseas education and working experience
Preferred:
Overseas working experience on public presentation and marketing.
Key Attributes:
• Well organized, detail oriented, and adaptable to changes
• Well-developed management skills
• Effective oral and written communication skills and excellent interpersonal skills
• Ability to work under pressure of timeline and milestones
• Ability to effectively prioritize workload and manage changes in direction
• Ability to work in a team environment