CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives.We are currently looking for a QA Manufacturing Science Manager for our Parenteral Products to join our team in St. Gallen. In this exciting position, you will be in charge of the Quality oversight of GMP data trending generated during operations throughout product lifecycle for parenteral products. You will be directly reporting to Head Quality Operations Parenteral Products.Key TasksSupport of method transfer to external partiesDefine, create and maintain Data trending and evaluation related to parenteral products supporting Quality Operations as well as CMO global evaluationOrganize stability studies and documents (routine and specific)Supporting RA CMC groups for regulatory submissionsWriting of annual product quality review and stability reportssupporting CMO audit teams in your area of responsibilityGive recommendations to Parenteral team when it comes to preventive actions or corrective actions in the light of products knowledge.General QA tasks related to analytics and stabilityYour ProfileThe knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.Minimum RequirementsMaster Degree in Life SciencesMinimum 3-5 years' experience in Pharmaceutical EnvironmentExperience in Quality Control and/or Stability ManagementFluent in German and EnglishPreferred RequirementsExposed to international experienceLean experienceUse of statistical toolsExperience with combination products is a plus. About CSL Vifor CSL Vifor aims to become the global leader in iron deficiency and nephrology.The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.For more information, please visit We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!
We are looking for a Regional Safety Officer, MedInfo Lead - Regulatory Support - QA-deputy to join the team at CSL Vifor.ResponsibilitiesPlan, direct, and monitor regulatory affairs activities so the organization has the permits, licenses, certificates, authorizations, and other approvals needed to conduct current and future business activities; and produce, sell, and distribute its goods and services.Support development of consistent roles and work processes.Oversee development of plans, cost estimates, and schedules. Acquire the necessary permits and approvalsMonitor regulatory developments and advise management on the potential impact of regulations on the organizationEstablish and maintain positive relationships with government agencies and other regulatory authoritiesRepresent the organization in matters before regulatory, legislative, or industry standards agencies so the organization's interests are advancedPrepare materials for legal counsel or external consultantsCreate and compile of registration application documentation.Regulatory system, data entry and maintenance in/of regulatory systems
QualificationsBachelor degree in a Life Science or Business Advanced degree in a Life Science (PhD, MD) or Business (MBA) an advantage3+ years regulatory experience in the pharmaceutical industryBiologics Regulatory experience preferred.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. About CSL Vifor CSL Vifor aims to become the global leader in iron deficiency and nephrology.The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.For more information, please visit We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!
At CSL Vifor, with our iron deficiency and iron deficiency anaemia expertise in heart failure, kidney disease, gastroenterology and inflammatory bowel disease, patient blood management and woman's health, we help patients affected by these conditions to live better, healthier lives. Building on our heritage and expertise in iron deficiency therapy, we are rapidly growing our presence in nephrology, with a focus on dialysis and rare disease. We put patients at the center of everything we do. We are currently recruiting for an accomplished Senior Manager Customer Operations, mainly focused on the North American region, to take an immediate assignment in our CSL Vifor business. In this position, you are part of the Global Supply Chain department and report directly to the Head of Customer Operations and Demand Management. You will actively collaborate with key internal and regional stakeholders to deliver robust, best-in-class, demand planning process. Leveraging rigorous data analysis and stakeholder insights, you shall work to improve forecast accuracy (80%) as a critical component to enable flawless supply to customers and ensure high customers' satisfaction. Responsibilities:Act as an interface between customers in the dedicated region and cross-functional departments.Ensure that customer orders are fulfilled to the best satisfaction of the customer and in line with contractual terms. Ensures availability of materials, as scheduled, and maintenance of inventory at appropriate levels.Establish and monitor key performance metrics (KPIs) to ensure continuous improvement of the movement of materials through various production processes.Support the achievement of the commercial targets in the dedicated region.Participate to the weekly product supply meeting: stress and escalate the potential issues (stock-out risks) or opportunities, recommend prioritization of urgent release, liaise with planning department, and produce a mitigation plan.Prepare and lead monthly demand reviews.Responsible for all the new product launches / Geographic expansions in the region.Best align the interests of customers and CSL Vifor in conflicting situations.Provide excellent coordination and collaboration with stakeholders.Ensure data integrity and quality of Master DataContribute to Supply Chain projects and initiatives.Qualifications:Bachelor's degree in international business, Business administration, Supply chain or related field7 + years of experience in a leading role in an international environment preferably within the pharmaceutical industry or medical device company, with a proven experience in a customer service and demand management rolegood knowledge of SAP S/4 ( Sales and Distribution) and IBP DemandGood understanding of GDP and other relevant regulationsDemonstrated success developing and meeting objectives in a team environment.Fluent in English mandatory, another language is a plus You are a pragmatic and self-motivated person with strong analytical skills. Thanks to your communication skills and your team spirit, you can build trust-based relationships with customers and internal stakeholders. Your high flexibility allows you to work effectively in a cross functional and cross regional environment with different cultures. Able to understand issues from multiple perspectives, you describe yourself as a result-oriented and highly adaptable person. You feel comfortable in a position where you act as an entrepreneur, take decisions, and convince others. About CSL Vifor CSL Vifor aims to become the global leader in iron deficiency and nephrology.The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.For more information, please visit We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!
Sie arbeiten in einem kleinen Team an unserem modernen Produktionsstandort in St. Gallen und stellen die korrekte und vollständige Versuchsdurchführung im Chemielabor sicher. Zu Ihrem vielfältigen Aufgabenbereich gehören folgende Tätigkeiten:Sicherstellen der effizienten und gerechten Durchführung und Dokumentation chemischer Synthesen im Rahmen der Prozessentwicklung, der Produktionsunterstützung und der PatententwicklungZeitgerechte und korrekte Durchführung von Analysen (HPLC, GPC, IR, Titrationen, DLS u. a.) an Produktionsmustern und selbst synthetisierten PräparatenGMP-gerechte Dokumentation sämtlicher AnalysenEinhaltung der GMP-Richtlinien sowie Anwendung der Qualitätsrichtlinien, Arbeitsanweisungen und Sicherheitsvorschriften im LaborSelbständige Koordination der Labor-TätigkeitenSchnittstelle zu anderen Abteilungen in Bezug auf Fragestellungen zur chemischen EntwicklungWahrnehmung der Aufgaben als Labor-/Geräteverantwortliche im LaborbereichEigenständige Bearbeitung kleinerer EntwicklungsprojekteUm diese Aufgaben erfolgreich zu meistern, bringen Sie nebst einer eigenverantwortlichen Arbeitsweise folgende Kompetenzen mit:Abgeschlossene Berufsausbildung zum Chemielaborant mit 3 Jahre Berufserfahrung, BSc. oder MSc. ChemieErfahrung in analytischer und präparativer Chemie von grossem VorteilSicherer Umgang mit MS-OfficeDeutsch in Wort und Schrift, gute Grundkenntnisse in EnglischLösungsorientierter TeamplayerFlexibilität sich rasch auf neue Projekte/Fragestellungen einstellen zu könnenSie sind zuverlässige, flexibel und übernehmen Verantwortung für die eigene Arbeit. Zudem verfügen Sie über sehr gute Kommunikationsfähigkeiten und schätzen die Arbeit im Team. About CSL Vifor CSL Vifor aims to become the global leader in iron deficiency and nephrology.The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.For more information, please visit We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!
CSL is a global biotherapeutics leader driven by its promise to save lives. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL - including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor -develops and delivers life-saving therapies to treat people with rare and serious medical conditions worldwide and employs 32,000 people.For our CSL Vifor (Switzerland), we are looking for aSenior Manager Drug Product DevelopmentWe offer a very exciting opportunity for a Senior Manager Drug Product Development to join the Chemical Product Development (CPD) Team whose primary focus is on drug substance, drug product, and analytical development in the area of small molecules.The main responsibility of the role is to define, plan, and deliver packages to support drug product development projects spanning different stages including early stage and feasibility studies, clinical development, up to process validation, and market authorization.To accomplish these objectives, the Senior Manager Drug Product Development will provide strategic direction, technical expertise, coordination, and oversight of CMC Science execution for a portfolio of projects including product development of injectables and solid oral forms.The incumbent will work in close collaboration with Contract Development and Manufacturing Organizations (CDMO's) as well as CSL cross-functional Teams including representatives from Analytical Development, Quality, Regulatory Affairs, Clinical Supply, Toxicology, Pharmacokinetic, Technical Operation, and Manufacturing. You are an ideal fit for this position if you thrive in fast-evolving environments, like to be flexible and have a problem-solving mindset.Role and Responsibilities: To manage formulation, process, and packaging development activities of New Chemical Entities (NCE's) drug products (parenteral aseptic solutions/suspensions and solid oral dosage forms) by collaborations with CDMO's as well as with internal resources To establish suitable DP development strategy including risk assessment and mitigation plans in collaboration with line manager, internal and external stakeholders and in line with the overall R&D, CMC and Clinical Development project plan, international guidelines and internal procedures To act as technical DP formulation and Process Development lead on project teams To monitor project plans and ensure milestones are met and deliverables becomes available in a timely manner To predict and highlight issues and criticalities and promptly inform about them the project manager and the rest of the team as well as the line manager To planning and implementing process improvement initiatives in support of CSL and industry best practices To plan and oversee the manufacturing of clinical trial supplies in compliance to cGMP and in line with clinical development plans To ensure the development of line extensions and new drug product development with third party companies as well as internal resources To apply Quality by Design principles appropriate to the drug product development stage and prepare related strategy and documentation in collaboration with technical development stakeholders and CSL dedicated team To plan, oversee and execute the PPQ with external partners and ensure the availability of pre-requisites for transferring the project to Technical Operations for commercial launch To support the preparation of submission files (IND, IMPD, NDA etc.) in accordance with overall project plan and to provide answers to HA questions in a timely manner To support cross functional teams to ensure projects are rolled out and delivered according to milestones, budget, and other relevant factors To coordinate site wide project activities with other sites/functions in global CSL networkBackground Education and Past experiences: Ph.D., Masters, or BSc (or equivalent) in pharmacy and / or extensive experience in relevant discipline 5+ years' of pharmaceutical experience with demonstrated expertise in formulation and process development of NCE's (parenteral aseptic solutions/suspensions and solid oral dosage forms) Experience with process scale-up, robustness studies and QbD Experience with development of large volume parenterals and combination products Experience with regulatory issues related to pharmaceutical development Demonstrated success in project management and continuous improvement processes Good knowledge of Good Manufacturing Practices (cGMPs) About CSL Vifor CSL Vifor aims to become the global leader in iron deficiency and nephrology.The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.For more information, please visit We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!
We are seeking a dynamic and strategic HR Business Partner (HRBP) to join our team at CSL Vifor. As the HRBP for Europe Commercial & Global Value Access Policy (GVAP) , you will play a pivotal role in driving strategic HR initiatives across your business group while ensuring consistency of practice across the enterprise. Reporting to the Head HR Global Commercial Organization CSL Vifor , you will serve as an active strategic leader and member of the European leadership team and functional GVAP leadership team , and collaborating closely with in-country business leaders and our colleagues of the wider CSL HR Organization to solve complex organizational and business challenges through people-related solutions. Key Responsibilities:Partner with the functional leadership teams to develop organization and workforce strategies aligned with the business' strategic plan and CSL's values-based culture.Collaborate with business leaders to understand challenges and opportunities, providing insights and value-added solutions across various HR areas, including talent management, performance management, change management, organization design, transformation for the business , capability development, strategic workforce planning, and employee engagement.Utilize data, insights, and analytics to drive business value and outcomes, leveraging expert knowledge from HR Centers of Excellence (COEs) and providing feedback on key initiatives.Champion a "OneHR" mindset and outcomes across the business, reinforcing collaboration and alignment between HR and other functions.Lead the strategic workforce planning leveraging CSL's methodology.Provide day to day leadership coaching to leadership teams and individual senior people leaders.Lead the talent agenda for LT including identifying critical roles, ensure robust development plans and succession pipelines in place, incorporating DEI activities.Partnering with COEs to drive organizational effectiveness through performance, engagement and culture programs.Combine business acumen with data analytics to inform and drive decision making.Support customer group leaders with cyclical processes such as IPM, annual merit review, engagement surveys and subsequent action plans. Collaborate strongly with Employee Relations COE on cases and contribute to risk management decisions. E nsure consistency in Industrial Relations across the business in collaboration with the Industrial Relations HRBP and the HRBP Agile team within Europe. Experience and background required:12 - 15 years' HR experience, including generalist and specialist roles in the pharmaceutical/biotechnology arena.Experience leading HR within a European region and/or global function and environment, with focus in commercial organisations.Experience acting as the senior strategic HR business partner for a global business or global function or regional function About CSL Vifor CSL Vifor aims to become the global leader in iron deficiency and nephrology.The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.For more information, please visit We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!
