Company Overview
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 a 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.

Job Openings
Director of Potency Assay
Job Locations US-PA-King of Prussia Job ID: 2019-5658

Application link: https://careers-wuxiapptec.icims.com/jobs/5884/director-of-potency- assay/job?mode=view&mobile=false&width=980&height=500&bga=true&needsRedirect=false&jan1offset=-300&jun1offset=-240

Responsibilities:
 Lead a team of cell based potency assay scientists to support analytical activity of drug substance (vaccine) technical transfer and process characterization in the lab
 Involved in the design, planning, and set-up of the vaccine potency assay lab.
 Be responsible for the highest quality analytical support for internal and client’s samples, while ensuring compliance with FDA/ICH guidelines/regulations, company SOPs, and safety regulations.
 Serve as a technical expert to transfer the method from client and verify the cell-based potency methods (qPCR based) for vaccines to support drug substance process development and PC.
 Develop/build a world-class cell-based potency assay analytical team including planning, recruiting/hiring, coaching/mentoring, and training for staffs and group leaders.
 Play a leading role in project management interaction with internal and external clients such as Process Development and Quality Control.
 Ensure potency staff receive appropriate safety training and maintain compliance and high quality standards
 Prepare, review, and approve technical documents including assay fit for purpose reports and analytical reports, etc.
 Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings.
 Continuously improve potency lab quality systems/documents, enhance data quality, and deliver high quality results
 Create a safety culture, enforce safety measures and ensure QC staff working in a safe environment
 Ability to work in a team environment and independently as required

Qualifications
 Bachelor, Master, or PhD Degree in immunology, virology, life science, analytical or related discipline.
 Candidate should possess strong and effective people management, problem solving and interpersonal skills and have a proven track record working cross-functionally across a wide variety of technical, business and operational areas.
 Experience with vaccines/viral testing and biosafety containment levels, preferably BSL-2 and above
 Familiar with qPCR technique and cell culture.
 Minimum of 5 years of vaccine industry experience preferred or minimum 8 years relevant biopharmaceutical industry.
 Minimum of 2 years of working experience in management role.
 Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required.


Senior Scientist Upstream Process Development
Job Locations US-PA-King of Prussia Job ID: 2019-5658

Application link: https://careers-wuxiapptec.icims.com/jobs/5658/senior-scientist-upstream-process-development/job?mode=view&mobile=false&width=980&height=500&bga=true&needsRedirect=false&jan1offset=-300&jun1offset=-240

Responsibilities
 Work independently on defined biopharmaceutical projects for development and/or characterization of vaccine upstream manufacturing processes.
 Manage project workflow to ensure on time delivery: from initial planning, experiment execution, to data evaluation.
 Design and execute lab-scale experiment in supporting upstream process development, verification, characterization, and tech transfer. Perform independent data analysis and interpretation and develop strategies for optimization and troubleshooting.
 Represent Vaccine Upstream Process Development Group in internal cross-functional teams and external communication with client.
 Manage technical transfer of processes into the non-GMP pilot plant or GMP production facility.
 Document development work in concise reports and provide project updates in written and oral presentations.
 Support maintenance tasks and new technology evaluations for laboratory instrumentation; interact with outside clients/vendors/suppliers

Qualifications
 The candidate should have background in one of the following fields: chemical engineering, biochemical or biological engineering, cell/molecular biology, biochemistry, or microbiology.
 Hands-on experience in mammalian cell culture or vaccine manufacturing using bioreactors is preferred.
 PhD degree and 0-2 years industry experience, or with MS degree and at least 3 years industry experience.
 Strong written and verbal communication skills are required, as well as ability to take on multiple tasks simultaneously.
 Excellent communication and good interpersonal skills, work well with diverse team members


Senior Scientist for Potency Assay
Job Locations: US-PA-King of Prussia Job ID: 2019-5877

Application link: https://careers-wuxiapptec.icims.com/jobs/5877/senior-scientist-for-potency-assay/job?mode=view&mobile=false&width=980&height=500&bga=true&needsRedirect=false&jan1offset=-300&jun1offset=-240

Responsibilities
 SME in potency assay, train junior scientist, perform cell culture/banking, qPCR based potency assay,
and testing samples in the King of Prussia potency lab. Involve onsite technical transfer at a local client’s site.
 Perform cell culture, cell banking, sample testing, and equipment maintenance according to requirements of process development labs and ICH guidelines.
 Perform assay fit for purpose of potency assay.
 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 of the potency lab in King of Prussia, PA.
 Ability to work in a team environment and independently as required.
Qualifications
 Master Degree or PhD in Immunology, Virology, Chemistry, Biochemistry, Molecular Biology, Analytical or related discipline.
 Must be familiar with qPCR and aseptic technique.
 Knowledge and expertise in the following fields: Biochemistry and immunology principles and techniques, such as cell thawing, cell culture, cell-based assays, etc.
 Experience with vaccines/viral testing and biosafety containment levels, preferably BSL-2
 Demonstrates good understanding of potency assay in the biopharmaceutical/vaccine industry.
 Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required.
 Limited international travel required
 Proficiency in English is required.
 Excellent communication skills (verbal, written, and presentation skills).
 Good computer skills, including Microsoft Word, Excel, PowerPoint, etc.
 Good technical writing skills
 Must be able to work in lab settings with exposure to cells and vaccines/viruses
 Must be able to wear appropriate PPE
 Critical thinking, scientific reasoning, and problem solving skills
 Adapt to changing priorities
 Organized and detail-oriented


Senior Scientist Downstream Process Development
Job Locations: US-PA-King of Prussia Job ID: 2019-5686

Application link: https://careers-wuxiapptec.icims.com/jobs/5686/senior-scientist-downstream-process-development/job?mode=view

Responsibilities
 Work independently on defined biopharmaceutical projects for development and/or characterization of vaccine downstream manufacturing processes.

 Manage project workflow to ensure on time delivery: from initial planning, experiment execution, to data evaluation.
 Design and execute lab-scale experiment in supporting downstream process development, verification, characterization, and tech transfer. Perform independent data analysis and interpretation and develop strategies for optimization and troubleshooting.
 Represent Vaccine Downstream Process Development Group in internal cross-functional teams and external communication with client.
 Manage technical transfer of processes into the non-GMP pilot plant or GMP production facility.
 Document development work in concise reports and provide project updates in written and oral presentations.
 Support maintenance tasks and new technology evaluations for laboratory instrumentation; interact with outside clients/vendors/suppliers
Qualifications
 The candidate should have background in one of the following fields: chemical engineering, biochemical or biological engineering, cell/molecular biology, biochemistry, or microbiology.
 Hands-on experience in downstream process unit operations and lab scale experimental execution.
 PhD degree and 0-2 years industry experience, or with MS degree and at least 3 years industry experience.
 Strong written and verbal communication skills are required, as well as ability to take on multiple tasks simultaneously.
 Excellent communication and good interpersonal skills, work well with diverse team members


Senior Scientist Analytical Sciences
Job Locations: US-PA-King of Prussia Job ID: 2019-5661

Application link: https://careers-wuxiapptec.icims.com/jobs/5661/senior-scientist-analytical-sciences/job?mode=view

Responsibilities
 Work independently on defined biopharmaceutical projects for development, qualification/validation of assays for vaccine development.
 Manage project workflow to ensure on time delivery: from initial planning, experiment execution, to data evaluation.
 Design and execute lab-scale experiment in supporting assay development, transfer, qualification, and validation. Perform independent data analysis and interpretation and develop strategies for optimization and troubleshooting.
 Represent Vaccine Analytical Science Group in internal cross-functional teams and external communication with client.
 Manage method transfer into the non-GMP analytical science group located at the other sites or GMP QC labs.
 Document development work in concise reports and provide project updates in written and oral presentations.
 Support maintenance tasks and new technology evaluations for laboratory instrumentation; interact with outside clients/vendors/suppliers
Qualifications
 The candidate should have background in one of the following fields: biochemical or biological engineering, analytical chemistry or biochemistry.
 Hands-on experience in vaccine assay development and lab scale experimental execution.

 PhD degree and 0-2 years industry experience, or with MS degree and at least 3 years industry experience.
 Strong written and verbal communication skills are required, as well as ability to take on multiple tasks simultaneously.
 Excellent communication and good interpersonal skills, work well with diverse team members


Please feel free to contact me at [email protected] or +1 609-703-3769 if you have any questions.
Thanks.