Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, the US, the EU, and Asia. The company currently employs over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Job description: As QA Drug Substance Operations Specialist, you will be responsible for providing online QA oversight to Drug Substance manufacturing operations in WuXi Biologics in Dundalk, Ireland. This is a crucial role within the Quality organisation with responsibility for directly supporting the manufacturing operations team daily, ensuring compliance with cGMP and corporate and local SOPs. Organization Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide 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 Description As QA Drug Substance Operations Specialist, you will 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 will be reporting to the QA Drug Substance Operations Group Leader. Your Responsibilities In this role, you will provide QA support to technology transfer and commercial manufacturing operations. Perform QA review of SOPs, risk assessments, change controls and other documentation, as applicable, associated with Drug Substance manufacturing operations Ensure that Drug Substance manufacturing operations are conducted according to appropriate cGMP behaviors and in compliance with SOPs, batch manufacturing records and other cGMP documentation as applicable. Liaise with Manufacturing Operations to ensure that all deviations, investigations, and batch manufacturing record reviews are performed, addressed and closed out in a timely manner as defined in SOPs. Work with Manufacturing Operations to ensure that all CAPAs, change controls, self-inspection observations, etc. relating to manufacturing operations are addressed and closed out in the required time frame. Liaise with manufacturing operations, QA, QC, Engineering, MSAT etc. in supporting daily operations. Ensure clear communication on issues and timely escalation as applicable. Identify opportunities for continuous improvement. Support internal Quality peers to ensure on-time disposition of drug substance material. Provide support for the preparation of regulatory submissions and inspection readiness activities. Perform onsite quality monitoring of GMP areas. Provide support for health authority inspections including responses to inspection observations, monitoring of follow up actions. Perform additional duties at the request of direct supervisor. Flexibility to take on additional tasks and responsibilities at the discretion of the QA Drug Substance Operations Group Leader. Will act as a role model for the QA function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Your Profile The ideal candidate for this position will have the following: Education A Bachelors degree in a technical discipline (e.g. biochemistry, chemistry, engineering) would be an advantage. Knowledge/Experience Candidates from Manufacturing Operations, Validation, Engineering, and other technical disciplines within the biotechnology and/or pharmaceutical industry will be considered butdemonstrated experience in Quality Management System, pharmaceutical regulations and continuous/process improvement tools will be required. Experience in the biotechnology and/or pharmaceutical industry within a Quality operations role preferred. Experience in performing internal audits is ideal. Experience in supporting Technology Transfer projects would be an advantage. Demonstrated knowledge of Quality Management System and continuous/process improvement tools. Personal skills Required: Adaptable, able to multi-task and handle tasks with competing priorities effectively to deliver site priorities. Demonstrated organisation and collaboration skills with a teamwork mind-set. Excellent communication skills (written and oral). Proactive attitude with good attention to detail. Analytical with demonstrated problem solving & root-cause analysis skills. Strong aptitude withability tointerprettechnical documentation. Strong knowledge of cGxP requirements and regulations. Knowledge of trouble shooting and problem-solving skills, e.g. formal root cause analysis such as Ishikawa diagrams, FMEA etc. Demonstrated knowledge of Quality Management System and continuous/process improvement tools. 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 mission - Any drug can be made, and any disease can be treated - dont 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 or contact us via Skills: QMS QA internal audits Tech Transfer Benefits: Bonus Life Assurance Paid Holidays Parking Pension VHI
Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, the US, the EU, and Asia. The company currently employs over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Job description: As a QC Microbiology Senior Scientist, you will be leading various technical projects/activities in the QC Microbiology Group of WuXi Biologics. The site is focused on startup activities involving commissioning and qualification work with aggressive timelines and potential candidates are required to be flexible in this regard. This also means that 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. Organisation Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide 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 Description As a QC Microbiology Senior Scientist, youll be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role, youll be reporting to the QC Microbiology Associate Director. Essential Duties and Responsibilities Specific Start up activities: Ensure the tasks associated with the startup and routine operations of a QC microbiology laboratory are carried out in a safe manner. Support QC Microbiology lab set-up, including laboratory design and construction queries, equipment installation and qualification utilizing principles of Operational Excellence and Lean Labs. Microbial organism identification, supporting facility qualification, cleaning validation, process validation, etc. Develop and maintain quality systems within the QC Microbiology Laboratory to ensure compliance to cGLP. Support of the commissioning/qualification activities of utility systems including but not limited to Water systems, Clean Steam and process gases, including development of sampling strategies. Aiding in the identification and development of Contract Test laboratories and strategies. Development of training material for the QC Microbiology Laboratory personnel. Support and lead microbial method validation and development of routine testing strategies. Sustaining operations: Lead QC microbiology routine testing, environmental monitoring, water monitoring, and testing including sterility, endotoxin, bioburden, Biological Indicators, Growth promotion and routine microbial identification strategies. Routine monitoring of laboratory KPIs, stock control of laboratory consumables and reagents and support for future expansion/upgrade projects. Serve as a technical expert to lead OOS, OOL, microbial contamination, adverse trends, utility and environmental excursion investigations, change controls, and CAPAs. Author technical documents including methods protocols, qualification/ validation protocols and reports, SOPs, etc. Support Risk Assessments for projects and business innovation initiatives from a microbiologicalperspective. Defines specific aseptic techniques to be performed for crucial process steps and provides meaningfulinput to processing operations as site develops. Keep abreast of current corporate and regulatory trends and requirements pertaining to laboratoryoperations and aseptic manufacturing. Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and AnalyticalDevelopment. Develop and maintain high level of scientific achievements for the company; expected to be a point ofcontact for project coordination, including email and client meetings. Ability to handle regulatory inspections from FDA, EMA, etc. and cGMP audits from clients, as wellas internal audits. Participate in relevant internal and external QC related audits. Ability to work in a team environment and independently as required Perform job specific tasks in compliance with applicable Regulations, International Standards, andWuXi Biologics Policies and Standard Operating Procedures. Thorough understanding of current Good Manufacturing Practices Perform all duties in accordance with GMP requirements, SOPs and controlled documents Flexibility to take on additional tasks and responsibilities at the discretion of the QC MicrobiologyAssociate Director Will act as a role model for the QC function and also the wider organisation in adherence to the WuXicorporate core values and PROUD culture. Person Specification Technical Competencies Possesses detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment. Familiarity with Pharmacopeia testing methods and requirements. Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines is a plus. Experience with regulatory/customer audits is a plus. Experience Management/supervision of personnel with particular attention to schedules and shifting priorities. Training/coaching of personnel. Experience with direct manangement of staff is a plus. Previous experience in a Quality Control/GMP environment is required. Knowledge Knowledge of microbial testing and microbial control in support of biopharmaceutical manufacturing is preferred but not required. Qualifications Ph.D. with/without post doc experience or MS in Microbiology or related field is desirable Minimum of an honours science degree in a related field with 5+ years relative experience is essential. Behavioural Competencies Ability to think critically and demonstrate troubleshooting and problem solving skills Excellent interpersonal, verbal, and written communication skills Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities. Onerous requirements Shift work and business travel may be required for this position as directed by departmental management. 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- dont 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 ator contact us via WuXi Biologics is an equal opportunities employer. Profile description: ? Skills: Coaching/Training Pharmacopeia microbial testing sterility endotoxin bioburden Benefits: Bonus Laptop Life Assurance Paid Holidays Parking Pension VHI
Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU and Asia. The company currently employs over 12,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: HR Regional Digital Solution Lead The HR Regional Digital Solution Lead will play a key role in bridging European HR needs with our global HR digital roadmap and lead regional HR technology initiatives. We are seeking an entrepreneurial and hands-on HR Regional Digital Solution Lead EUto join our expanding HR Digital Solution team. Organization Description: WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals. 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. Department Description As HR Regional Digital Solution Lead, youll 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 will report to the Global Digital Solution Head. Key Responsibilities: Act as the European lead for all HR digital tools and systems, owning their local relevance, adoption, and continuous improvement. Proactively identify regional pain points and improvement opportunities; develop and implement innovative HR tech solutions. Partner with HRBPs, CoEs, recruiting team, and shared services teams in Europe to understand business needs and define digital solution strategies. Collaborate with global HR Digital Solution team in China to align on standards, architecture, and system enhancements. Champion the change management efforts and drive user adoption across the region. Co-lead regional digital projects including pilot programs, integration efforts, and employee experience initiatives. Facilitate agile communication and value delivery between regional and global HR functions. Qualifications/Experience Required: Bachelors or Masters degree in HR, Business, Technology, or related field. 5+ years of experience in HR technology or HR digital transformation projects. Proven experience working in start-up or scaling environments within HR tech, HRIS, or consulting. Entrepreneurial spirit with a proactive, solution-oriented approach. Strong business acumen and ability to work with ambiguity and autonomy. Experience with modern HR tools, specifically SAP Success Factors. Effective communicator and collaborator with cross-cultural sensitivity. Comfortable working in a matrix, multicultural team structure. HR system product design experience equipped with user-centric mind-set and related methodologies, e.g., UI design, design thinking, service design is a plus. Consultancy working experience is a plus. Certifications of PMP, CSM, or NPDP is a plus. 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! Apply now ! Would you like to know more before you apply? Please visit us at or contact us via . WuXi Biologics is an equal opportunities employer. Skills: Software Development Problem Solving Information Technology Benefits: Bonus Parking Pension VHI
Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU and Asia. The company currently employs over 10,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: Manufacturing Buffer Lead (Associate Director) The Manufacturing Buffer Lead will play a pivotal role in theManufacturing department. This role will align with Manufacturing Shift Leads, providing support to ensure the efficient and successful execution of production and associated GMP activities. Organization Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide 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. Department Description As Manufacturing Buffer Lead you will 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 will report to the Manufacturing Senior Director. Your Responsibilities Responsible for Buffer to ensure and complete batch production activities under cGMP compliance. Under limited supervision, can independently coordinate the execution of projects and lead operations to accomplish production on schedule. Ensure following EudraLex GMP and all applicable cGMP guidelines. Communicate status of process, personnel, safety, environment, maintenance, and other issues, in a timely manner to regularly to management required, at the appropriate level of detail. Keep a safe environment in cGMP facility. Responsible for the safety education and supervision of team members. Coordinate with QA to ensure GMP compliance, mange change controls, deviation investigation and CAPA implementation, and support client audit and agency inspections. Collaborate with MSAT/PEV and related groups for technology transfer and validation. Author and review GMP documents including, but not limited to SOP/MBR/URS/FAT/SAT, as well as review the executed batch record. Responsible for ensuring all team member training is up to date, and qualified to perform the operation per cGMP compliance. Responsible for mentoring and developing team members and build a strong team. Take initiative to optimize the operation and continuous improvement. Responsible for daily management within the group and department. Create a positive team culture, motivate, retain, and develop existing team members and recruit new employees. Will be flexible to take on additional tasks and responsibilities at the discretion of the Manufacturing Senior Director. Will act as a role model for the Manufacturing function and the wider organisation in adherence to the WuXi Biologics corporate core values and PROUD culture. Your Profile: The ideal candidate for this position, will have the following: Education B.Eng or B.Sc in Chemical or Process engineering or equivalent is required. A postgraduate qualification in an engineering or science discipline would be advantageous. Knowledge/Experience Technical / Engineering knowledge of Upstream and Downstream biologics processes is desired. Knowledge / experience in the operation of GMP. Experienced in the management of complex cross functional projects. Personal skills A strong team leader with the ability to adapt to daily challenges of a manufacturing work environment whilemaintaining positive and productive attitude and fostering this attitude among direct reports. Excellent verbal and written communication and presentation skills. Excellent interpersonal skills with the ability to work effectively with staff at all levels of the organisation. Results oriented, with the ability to manage multiple priorities in a short period of time. Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and ourcustomers expectations. Onerous requirements Must be willing to travel as required internationally to fulfil the responsibilities of the position. 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 - dont 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 ator contact us via. WuXi Biologics is an equal opportunities employer. Skills: Leadership MFG Biologics Drug Substance organisational skills Benefits: Parking Pension VHI
Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, the US, the EU, and Asia. The company currently employs over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Job description: As the Supply Chain Management and Warehouse QA Specialist, you will play a key role in supporting supply chain and warehouse functions to ensure the highest standards of professional excellence and quality assurance in the business, with responsibility for supporting the Pharmaceutical Quality System (PQS) in place, adhering to all regulatory, cGMP and company requirements and ensuring all necessary plans and standards are achieved by consistently maintaining a high level of quality. Organisation Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialisation) with global customers in the biopharmaceutical and healthcare industries. Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide 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 Description As Supply Chain Management and Warehouse QA Specialist, youll be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role youll be reporting to the Supply Chain Management and Warehouse QA Team Lead. Your Responsibilities Incoming receipt and inspection of goods delivered into the warehouse. Approval and release of materials within SAP. Material labelling activities. Review of physical inventory reports. Monitoring of shipment and disposal operations. Assessment of calibration records and temperature excursions. Room and equipment release for sampling and dispensing operations. Involved in supplier non-conformance and complaint activities. Participate in continuous evaluation and improvement initiatives, focusing on quality and cGMP. Inspection and monitoring of all warehouse activities as per EU regulations and WuXi requirements. Participation in warehouse tours during audits. Collaborating internally and across the WuXi network to achieve quality goals. Perform all duties in accordance with cGMP requirements, SOPs and controlled documents Deputize SCM & WH QA Team Lead whenever delegated. Will be flexible to take on additional tasks and responsibilities at the discretion of the SCM & WH QA Team Lead. Will act as a role model for the Quality Assurance function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Requirements Technical Competencies Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures). Strong knowledge of cGxP requirements and regulations. Knowledge of trouble shooting and problem-solving skills, e.g. formal root cause analysis such as Ishikawa diagrams, FMEA etc. Demonstrated knowledge of Quality Management System and continuous/process improvement tools. Experience 2+ years experience in the biotechnology and/or pharmaceutical industries within a Quality role,preferably in QA or QC or Warehouse & Distribution (GDP) or Manufacturing Operations within thebiopharmaceutical/ pharmaceutical industry. Experience working on QA/QC incoming material inspection or warehouse operations would be advantage. Experience working with SAP would be an advantage. Experience in performing internal audits would be an advantage. Knowledge Demonstrated knowledge of Quality Management System and continuous/process improvement tools. Qualifications Preferable that the individual has qualification Degree in Biopharmaceutical/ Pharmaceutical Science or other related science discipline. Behavioural Competencies Essential to have: Proven decision-making capabilities. Demonstrated collaboration, negotiation, conflict resolution skills and inclusive approach with a teamwork mindset. Analytical, problem solving & root-cause analysis skills Able to challenge the status quo with a continuous improvement mindset. Excellent interpersonal, verbal, and written communication skills Self-starter and self-motivated; organized with good attention to details. 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. Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards,and our customers expectations. 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 - dont 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 or contact us via WuXi Biologics is an equal opportunities employer. Skills: QA QC Warehouse & Distribution (GDP) Trackwise cGxP QMS Benefits: Bonus Canteen Life Assurance Paid Holidays Parking Pension VHI
Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU and Asia. The company currently employs over 12,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: As Manufacturing Systems Specialist, you will be responsible for establishing the Manufacturing Systems team within the Manufacturing Operations group. The incumbent will provide expert support to the manufacturing team in the areas of SAP, LIMS, finite scheduling (Orchestrate) and benchtop equipment. Department Description As Manufacturing Systems Specialist, you will 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 will be reporting to the Manufacturing Systems Lead. Your Responsibilities In this role, you will be a key member of Manufacturing Operations team in WuXi Biologics Ireland. Provide expert support to the Manufacturing department in the areas of SAP, LIMS, Trackwise and Finite Scheduling. Process and System owner for Manufacturing benchtop equipment. Responsibilities in this area will include but are not limited to management of the MFG benchtop support e.g., vendors, maintain an accurate equipment list of benchtop equipment and ensure all required system SOPs are in place. Ensure all Manufacturing benchtop equipment are maintained in a qualified state by collaborating with relevant departments on all aspects of benchtop equipment qualification lifecycle (URS to decommissioning). Co-ordinate vendor visits on site for bench top support, qualification and maintenance as needed. Provide input to budget for systems. Collaborate with MT and MSAT groups on technical transfer and process validation as required. Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections. Ensure that the MFG training team are supported regarding benchtop equipment training and troubleshooting as needed. Ensuring continual improvement of manufacturing documentation (SOPs MBRs, OJTs) for areas of responsibility to ensure they are current, accurate, and clear. Communicate operational status regularly to senior management, as required, at the appropriate level of detail. Assist the MFG systems lead to coordinate the work between theMFG systemsgroups and other functional groups to meet the production objectives and timelines. Responsible for identifying and assessing new models of benchtop and new equipment as required. Will be flexible to take on additional tasks and responsibilities at the discretion of theManufacturing Operations Associate Director and Systems lead. Support future initiatives such as electronic batch records, electronic logbooks, etc. on behalf of Manufacturing. Will act as a role model for the Manufacturing function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Your Profile: The ideal candidate for this position, will have the following: Education Diploma, BSc, MSc or PhD in Chemical Engineering, Bioscience, Biotechnology or Analytical Science Knowledge/Experience Required: More than 2 years in biopharmaceutical manufacturing. Experience with GMP systems such as SAP and Benchtop equipment qualification and operation etc. Ideally have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control. Experience in working with the cross-functional teams. Strong team lead with the demonstrated ability to manage and support manufacturing operations in a flexible and dynamic team environment. A proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant. The individual need to have good understanding in DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification). Knowledge of GMP systems such as SAP and Benchtop equipment qualification and operation etc. Ideally knowledge and experience of scheduling software including Orchestrate. Personal skills Required: Ideally, experienced in establishing a Manufacturing department and working in a team in a greenfield context of similar size and scale. A strong collaborator with the ability to adapt to daily challenges of a manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among direct reports. Excellent verbal and written communication and presentation skills. Excellent people skills with the ability to work effectively with staff at all levels of the organisation. Ability to work on own initiative and be initiative-taking. Results oriented, with the ability to manage multiple priorities in a short period of time. Excellent organizational and planning skills and strong diligence 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 - dont 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 or contact us via WuXi Biologics is an equal opportunities employer. Skills: MFG Systems Biologic Processing Troubleshooting Benefits: Bonus Parking Pension VHI
Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, 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. Job description: As a Financial Accountant, youll play a key role in ensuring the integrity of our financial reporting with timely and accurate financial information. Youll have strong analytical skills and a solid grounding in accounting principles, eager to gain exposure to a multinational organization within the rapidly expanding pharmaceutical industry. Organisation Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialisation) with global customers in the biopharmaceutical and healthcare industries. Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide 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 Description As a Financial Accountant, youll be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role youll be reporting to the Associate Director Financial Reporting & Controlling. Essential Duties & Responsibilities Fixed Assets controlling Maintaining the Fixed Asset register- additions / disposals. Physical asset verification. Monthly reporting. Month End Controlling and Reporting Preparation of monthly SAP journal entries including accruals and prepayments. Preparation of monthly balance sheet reconciliations. Assist on Monthly/Quarterly reporting package preparation. Inventory general ledger controlling. Reporting Insurance cost analysis and policy monitoring and controlling. Assist in timely and accurate data collation in support of cashflow management process. Assistance with internal and external audit queries. Work with finance team and other departments for the submission of the CSO and other statutory reporting requirements. Timely and accurate execution of intercompany recharges to other group companies. VAT / Intrastat / VIES reporting Finance process and system improvement Support the "Lean Finance" approach and contribute continuous improvement recommendations on process improvements. General Will be flexible to take on additional tasks and responsibilities at the discretion of the Associate Director Financial Reporting & Controlling. Will act as a role model for the Finance function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Knowledge and Experience 1+ years general accounting experience within a Finance function is essential Experience working in a multinational manufacturing environment is preferable. Strong working knowledge of SAP FICO or Oracle (or other large ERP systems) is essential. Excellent MS Excel skills are essential. General accounting experience. Strong numeracy skills and attention to detail. Strong problem solving and analytical skills. Fluent in MS Office suite. Qualifications A degree in Business, Accounting, or Finance (or other relevant/equivalent qualification) is essential. Recently qualified or part qualified ACA/ACCA/CPA/CIMA and working towards full qualification is essential. Behavioural Competencies Ability to collate and analyse large amounts of data in a methodical and structured manner. Ability to adapt and change quickly in a fast-paced learning environment. Dynamic team player that can work proactively on cross-functional teams. Excellent oral communications, business writing skills, inter-personal and presentation skills. 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 - dont 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 ator contact us via WuXi Biologics is an equal opportunities employer. Skills: Accounting SAP FICO Oracle MS Excel Benefits: Bonus Laptop Life Assurance Paid Holidays Parking Pension VHI
