Job Information
WuXi AppTec Senior Director, Large Molecule Bioanalytical Services in Shanghai, China
Overview
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.
This 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 Location: Shanghai, China
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.
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
Essential:
PhD or Master degree in pharmaceutical sciences, immunology, biology or a related field
A minimum of 8 years of industrial experience in CROs and/or pharmaceutical companies
A minimum of 5 years direct experience in large molecules bioanalysis in support of preclinical and/or clinical PK/TK/PD, ADA, and vaccine studies
Strong understanding of PK
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, etc.
Fluent in both English and Mandarin, written and oral
Preferred:
- Overseas education and working experience
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
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Job Locations CN-Shanghai
Job ID 2022-9792