WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and strong value proposition to our global clients. As of December 31, 2018, there were a total of 205 integrated projects, including 97 projects in pre-clinical development stage, 94 projects in early-phase (phase I and II) clinical development, 13 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 280,000 liters by 2022, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network.
- Provide analytical support for later stage vaccine development in the King of Prussia lab.
- Perform cell culture and sample analysis using cell-based potency assay, separation assay and other bioanalytical assays as needed to the requirements of process development labs and ICH guidelines.
- Perform method development and qualification for potency assay and other bioanalytical assays.
- Manage method transfer into the non-GMP analytical science group located at the other sites or GMP QC labs.
- Document completed lab work and results promptly, clearly, and accurately.
- Prepare presentations and written reports of experimental results and analyses and effectively communicate with internal stakeholders and client.
- Write and revise analytical methods, testing protocols and reports, and other technical documents.
- Assist in the lab set-up and equipment maintenance of the potency lab and analytical lab in King of Prussia, PA.
- Ability to work in a team environment and independently as required.
- Bachelor or Master Degree in Biochemistry, Analytical Chemistry, Molecular Biology or related discipline, and with 1-2 year industry experience.
- Experience with aseptic techniques, cell culture, bioassays including cell-based potency assays and ELISAs, and molecular biology techniques (qPCR, western blot) is preferred.
- Experience with analysis of biological molecules using techniques of HPLC/UPLC, electrophoresis, etc.
- Experience with vaccines/viral testing and biosafety containment levels, preferably BSL-2 is preferred.
- Must be able to follow and execute SOPs and report data in an accurate and timely manner.
- Strong aptitude and ability to work collaboratively and effectively with internal and external partners
- Excellent communications skills (verbal, written, and presentation skills).
- Good computer skills, including Microsoft Word, Excel, PowerPoint, etc.
- Good technical writing skills
- Proficiency in English is required.
- Must be able to work in lab settings with exposure to cells and vaccines/viruses
- Critical thinking, scientific reasoning, and problem solving skills
- Adapt to changing priorities
- Organized and detail-oriented
- Limited international travel might be needed.