Overview The Senior Scientist is part of the Quality Control (QC) department of STA Pharmaceuticals Switzerland. The Team is responsible for introducing new raw materials, drug substance (API), and drug product (Bulk) as…
Overview WuXi Biology at San Diego, a division of WuXi AppTec Company, is seeking a highly motivated and established Scientist II with deep and broad expertise in drug discovery and cutting-edge technologies in drug deli…
Skills: mRNA LNP Design, Antibody Conjugation, In Vitro Cell-Based Assays, Drug Delivery Technologies, Scientific Proposal Writing
Overview WuXi Chemistry, an integral part of WuXi AppTec, is looking for a proactive and detail-oriented Event Marketing Specialist to support and drive the planning and execution of impactful events across Europe, inclu…
Overview The EHS Manager will be responsible for maintaining and managing day-to-day health, safety, emergency response, and environmental compliance for the STA Middletown DE location. The EHS Manager will also be respo…
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Other
postgraduate degree
Posted 34d ago
Apply by Jun 23
~40 hrs/week
Responsibilities
Lead the end-to-end introduction of new materials and technologies within the Quality Control department. Provide technical expertise for troubleshooting, deviations, and GMP compliance while mentoring team members.
Requirements
Requires a Master's or PhD in Life Sciences, Chemistry, or Pharmacy with approximately 10 years of experience in a GMP pharmaceutical environment. Must possess strong expertise in chromatography and professional fluency in English or French.
Full job description
Overview
The Senior Scientist is part of the Quality Control (QC) department of STA Pharmaceuticals Switzerland. The Team is responsible for introducing new raw materials, drug substance (API), and drug product (Bulk) as well as new technologies at the site. The Senior Scientist provides technical and scientific expertise to support transfer/verification/validation of new methods and investigation and troubleshooting of analytical issues (commercial or not). Additional duties includes participating to registration stability studies, participating to supplier qualification & supplier Audit, participating to cleaning validation and validation processes, and leading QC risk assessments.
The Senior Scientist assists other technical support team members with questions and technical issues and acts as a point of contact in absence of the Manager. He/she plays an expert role and shares know-how with colleagues regarding methods, deviation, CAPA, Change control and QC processes. As a Senior QC Team Member, this position acts as a center of competences reflecting experience, transferring knowledge and support other team members in all aspects of their daily work.
This position is located at STA Pharmaceuticals Switzerland site in Couvet.
Responsibilities
Key Responsibilities:
Lead end-to-end introduction of new materials, including analytical strategy, method transfer/validation, specifications, and QC deliverables
Support implementation of new technologies in the QC laboratory
Provide technical expertise for troubleshooting, deviations, investigations, and CAPAs
Represent QC in cross-functional projects and act as QC point of contact
Contribute to supplier qualification, audits, and risk assessments
Ensure GMP compliance of laboratory activities, methods, and documentation
Act as a subject matter expert, mentor team members, and support daily operations
Manage and review QC documentation (protocols, reports, procedures)
Support inspections and ensure adherence to EHS standards
Qualifications
Profile:
Master’s or PhD in Life Sciences, Chemistry, Pharmacy or equivalent
~10 years of experience in a GMP pharmaceutical environment
Strong expertise in material introduction, analytical methods, and chromatography (HPLC/GC/UPLC)
Solid knowledge of cGMP, pharmacopeia, validation, data integrity, and QC systems
Strong problem-solving, communication, and cross-functional collaboration skills
Fluent in English or French (professional level in the other language)
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
Established in December 2000, WuXi AppTec (NYSE: WX) is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with operations in China and the United States.
WuXi AppTec has successfully established a fully integrated services and technology platform during the past decade. The company built its initial capabilities around discovery chemistry and has further enhanced the integrated services with analytical services, bio-analytical services, process research, process development services, API manufacturing services, DMPK/ADME, discovery biology, pharmacology, formulation, toxicology, genomic services, biologics manufacturing services, antibody and biological research reagent manufacturing and sales, and most recently clinical research and regulatory services.
WuXi AppTec has developed from four founders and a single laboratory in December 2000 to 10,000 employees and 5 million square feet of laboratory and manufacturing space, including facilities under construction. The company is actively improving its capabilities and capacity through new expansions in its global business. Capitalizing on the great advantage of conducting R&D services both in China and in the U.S., WuXi AppTec is building an alternative R&D engine to serve the global life-science industry.
药明康德新药开发有限公司于2000年12月成立,是全球领先的制药、生物技术以及医疗器械研发开放式能力和技术平台公司,在中美两国均有运营实体。
十多年来,药明康德成功打造了全方位一体化的研发服务技术平台。创建之初,药明康德凭借其在发现化学合成领域的雄厚实力实现了全面发展。近几年来,我们又新增了一系列一体化服务,包括分析服务、生物分析服务、工艺研究、工艺研发服务、API生产服务、药物代谢及其动力学服务、研发生物学、药理学、制剂、毒理学、基因组服务、生物制剂生产服务、抗体及生物诊断试剂的生产和销售服务以及临床研发和产品注册服务等。
从 2000 年 12 月创立至今,药明康德的员工数从4 人增长至 10000 人,实验室由当初仅有的一间增长到近46 万平方米已有及在建研发基地和生产厂房。与此同时,药明康德还在不断增强服务能力,拓宽服务领域,以更好地服务公司持续增长的全球业务需求。作为一家全球领先的医药研发服务公司,药明康德将继续致力于在中美两国为全球客户提供高质量的医药研发服务,帮助研发出更多造福患者的新药及产品。
Offices: Shanghai, CN
Discovery ChemistryADME/DMPKFormulationand BioanalysisSocial MediaMedia and EntertainmentDigital Media
Established in December 2000, WuXi AppTec (NYSE: WX) is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with operations in China and the United States.
WuXi AppTec has successfully established a fully integrated services and technology platform during the past decade. The company built its initial capabilities around discovery chemistry and has further enhanced the integrated services with analytical services, bio-analytical services, process research, process development services, API manufacturing services, DMPK/ADME, discovery biology, pharmacology, formulation, toxicology, genomic services, biologics manufacturing services, antibody and biological research reagent manufacturing and sales, and most recently clinical research and regulatory services.
WuXi AppTec has developed from four founders and a single laboratory in December 2000 to 10,000 employees and 5 million square feet of laboratory and manufacturing space, including facilities under construction. The company is actively improving its capabilities and capacity through new expansions in its global business. Capitalizing on the great advantage of conducting R&D services both in China and in the U.S., WuXi AppTec is building an alternative R&D engine to serve the global life-science industry.
药明康德新药开发有限公司于2000年12月成立,是全球领先的制药、生物技术以及医疗器械研发开放式能力和技术平台公司,在中美两国均有运营实体。
十多年来,药明康德成功打造了全方位一体化的研发服务技术平台。创建之初,药明康德凭借其在发现化学合成领域的雄厚实力实现了全面发展。近几年来,我们又新增了一系列一体化服务,包括分析服务、生物分析服务、工艺研究、工艺研发服务、API生产服务、药物代谢及其动力学服务、研发生物学、药理学、制剂、毒理学、基因组服务、生物制剂生产服务、抗体及生物诊断试剂的生产和销售服务以及临床研发和产品注册服务等。
从 2000 年 12 月创立至今,药明康德的员工数从4 人增长至 10000 人,实验室由当初仅有的一间增长到近46 万平方米已有及在建研发基地和生产厂房。与此同时,药明康德还在不断增强服务能力,拓宽服务领域,以更好地服务公司持续增长的全球业务需求。作为一家全球领先的医药研发服务公司,药明康德将继续致力于在中美两国为全球客户提供高质量的医药研发服务,帮助研发出更多造福患者的新药及产品。
Offices: Shanghai, CN
Discovery ChemistryADME/DMPKFormulationand BioanalysisSocial MediaMedia and EntertainmentDigital Media