Job Description
As a QC Separations Senior Scientist, you will lead a range of technical projects and activities in the QC Separations group at WuXi Biologics. The site is focused on start-up activities involving commissioning and qualification aligned with project timelines. As part of the project, the role will evolve based on project timelines.Organization DescriptionWuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We are one of the world's top three contract development and manufacturing companies for biopharmaceuticals, providing our clients with a world-leading open access technology platform. We enable our clients to research, develop, and manufacture drugs from the concept phase to commercial manufacturing.Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.Department DescriptionAs a QC Separations Senior Scientist, you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.In this role, you’ll be reporting to the QC Separations Team Lead.Your ResponsibilitiesKey member of the QC Team in Dundalk. Will support execution of the strategy and business planning processes, ensuring cross-functional collaboration.From a QC functional capacity, support the design, construction, and commissioning of the new facility for the production of drug substance.Support the development of a Biologics QC separations product-testing team including providing technical guidance, coaching/mentoring, and implementing training for Scientists and Associate Scientists.Perform analytical method transfer, verification/validation, and routine analysis using various analytical techniques; including but not limited to HPLC/IC (Size Exclusion, Ion Exchange, Reverse Phase, Hydrophobic Interaction etc), CE, cIEF, and UV.Develop a process to manage scheduling for the Scientist and Associate Scientist in line with testing turnaround time and requirement.Provide the highest quality analytical support for Biologics manufacturing, while ensuring compliance with cGMP guidelines/regulations, company SOPs, and safety regulations.Communicate, collaborate, and cooperate with QC functional teams and other departments to support lab start-up and routine operations.Serve as a technical expert supporting applicable non-conformances, atypical/OOS investigations, change controls, deviations, CAPAs, and troubleshooting.Develop and maintain high level of scientific achievements for the company; expected to be technical SME point of contact for the team and QC.Seek opportunities for continuous process improvements/improved operational excellence.Ensure the tasks associated with the start-up and routine operations applicable to the role are carried out in a safe manner.Support Risk Assessments for projects and business innovation initiatives from a separations perspective.Prepare, review, and approve technical documents including method protocols, qualification and validation protocols and reports.Will be flexible to take on additional tasks and responsibilities at the discretion of the QC Separations Lead.Potential candidates may be required to carry out additional job functions that are not described in this job description but will be associated with the role.Person SpecificationExperience working in a QC function in a ‘greenfield’ context of similar size and scale is ideal.Previous experience handling regulatory inspections from FDA, EMA, etc. and GMP audits from clients, as well as internal Quality Assurance is advantageous.Experience working in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology, Engineering, IT, or other related field is desirable.Technical expertise in tech transfer, validation, and troubleshooting Biologics product-testing methods, including HPLC, CE, and cIEF to support QC release and stability testing in a GMP-environment according to USP, EP, and ChP requirements is preferred.Experience6+ years experience working within a Quality Control environment, with a well-rounded exposure to all areas in this field. Experience working in the Biologics industry is essential.Previous experience as a Senior Scientist is desired.Experience with LIMS, Empower, ECM, Master Control, Trackwise or similar systems is required.Experience with Microsoft Word, Excel, PowerPoint, Visio, and Project is required.Previous experience in supervision with particular attention to coaching, schedules, and shifting priorities is desirable.Previous experience working in a CMO is an advantage.KnowledgeKnowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals.QualificationsBachelor’s degree (Level 8/9), may have Masters or Doctoral in related science/quality discipline required.Excellent interpersonal, verbal, and written communication skills.Able to think critically and demonstrate troubleshooting and problem-solving skills.Self-starter and self-motivated; organized with good attention to detail.Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.Results oriented, with the ability to manage multiple priorities in a short period of time.Collaborative and inclusive approach to work and your colleagues.May be required to travel occasionally to carry out duties of this role.As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential!If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential.Apply now!Would you like to know more before you apply? Please visit us at WuXi Biologics or contact us via talentacquisition@wuxibiologics.com.WuXi Biologics is an equal opportunities employer. #J-18808-Ljbffr