Group leader or Director level, Bioanalytical Services-Immunoassay
- Lead a team of Bioanalytical scientists in immunoassay area to provide GLP-compliant service to work-class pharma and biopharma.
- Be required to 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 antidrug antibody (ADA) 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
- Ph.D. or Master degree in pharmaceutical sciences, immunology, biology or a related field
- Industrial experience in assay development for large molecules quantitation in support of preclinical and clinical PK/TK/PD, ADA,and vaccine studies is highly desired
- Familiar with pharmaceutical R&D process
- Demonstrate capability and confidence to build, train and lead a group
- Hands-on experience with ligand binding and cell-based assay in support of biologics and vaccine development in GLP environment.
- Experience with protein quantitation using LC/MS/MS platform is a plus
- Strong interest and demonstrated skills with state-of-art equipment such as Gyros, Luminex, MSD, Biacore, etc.
- Good interpersonal communication skills; excellent oral and written English
Any applications,pls contact:email@example.com;firstname.lastname@example.org