Bioanalysis Technical Expert-BAS上海(J23178)

Technical Expert-Large Molecule

• Working in immunoassay area to provide GLP-compliant service to world-class pharma and biopharma.
• 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
• Develop and maintain high level of scientific achievements for the BA team. Be expected to be point of contact for technic supporting, and troubleshooting in assays, , including email and video/tele- conference with customers.
• 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 regulatory agency inspections, and serve as a technical liaison to engage and onboard domestic and international clients.
• Prepare, review or approve assay validation and bioanalytical reports and present data to clients
• Provide training and mentorship to internal staffs

Method Development Leader- Small Molecule

Key responsibilities

• Lead the method development with bioanalytical scientists in LCMS/MS small molecular team to provide GLP-compliant service to world-class pharma and biopharma;
• Serve as an internal expert to design, develop and validate assays and utilize professional knowledge and experience to solve complex technical issues in small molecule clinical bioanalysis;
• Develop and maintain high level of scientific achievements for the BA team. Be expected to be point of contact for technic supporting, and troubleshooting in assays, , including email and video/tele- conference with customers.
• Team working with bioanalytical team including SD/PI, bioanalyst and other related scientific staff. Oversee multiple MD projects/studies conducted at the same time: Manage activities, aggressive timelines, priorities, resources, establish work schedules, and keep meticulous records to ensure on time deliverables. Serves as a center to connect between MD and the project teams;
• Involve in process optimization to improve operation efficiency and quality to reduce the cost and improve customer’s satisfaction.
• Be well versed with WuXi’s program management system in tracking the progress of projects with regard to meet timeline and finance milestones, follow-up actin items for resolutions.
• 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.
• Participate in regulatory audits of projects; Perform duties complied with the related SOPs and according to OECD, USFDA and NMPA (Previous CFDA), etc., GLP guidelines as well as other applicable regulations.
• Provide training and mentorship to internal staffs

Essential

• PhD degree in Biochemistry, Analytical Chemistry, Pharmacy, or a related field, or a Master’s degree in a related field with extensive clinical work experience (5+years’ work experience).
• A minimum of 2/3 years of industrial experience in CROs and/or pharmaceutical companies
• A minimum of 3/5 years direct experience in large molecules bioanalysis in support of preclinical and/or clinical PK/TK/PD, ADA, and vaccine studies
• Strong understanding of large molecules bioanalysis technologies and GLP/GCP/GCLP
• In-depth understanding of small molecule bioanalytical techniques, including but not limited to HPLC, LC-MS, GC-MS, and their applications in clinical trials.
• 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.

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