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 ViforCSL 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 viforpharma.comWe want CSL to reflect the world around usAs 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!
Gesundheit Nord gGmbH Klinikverbund Bremen
Switzerland - Zurich
April 10, 2024
Netzwerkadministrator/in - Senior (m/w/d) Für den Geschäftsbereich Medizin- und Informationstechnik suchen wir dich zur Verstärkung unseres Teams. • IT-Expertise dort einsetzen, wo sie Menschen wirklich hilft: • im Krankenhaus. • Die Gesundheit Nord gGmbH ist einer der größten...
Switzerland - Bern
May 10, 2024
Future-oriented technology is our passion and in order to always think one step ahead, we need a team of forward thinkers. • Do you want responsibility and are you looking for challenges? As an IT service technician (all genders) in the field, you will plan and install technical systems, from...
Finsterwalder Transport and Logistik GmbH
Switzerland - Zürich (Kreis 11)
May 2, 2024
Staplerfahrer (m/w/d) Finsterwalder Transport & Logistik GmbH Jobportal Türkheim Berufserfahrung Lagerarbeit Transport Voll/Teilzeit WIR bei Finsterwalder Seit mehr als 80 Jahren bietet die Finsterwalder-Gruppe Transport-, Logistik-, Warehouse- und Fulfillment-Lösungen als Dienstleistung für...
Switzerland - Château-d'Oex
May 21, 2024
Située dans la région du Pays-d'Enhaut, notre Fondation propose une offre en soins et a accompagnement à toute personne atteinte dans sa santé mentale, au sein de différents établissements médico-sociaux (EPSM et EMS). Nous accueillons à ce jour 96 Résidents et comptons quotidiennement sur les...
Switzerland - Zürich (Kreis 11)
April 5, 2024
Nathalie Neumann-Knittel Schwerpunkt: • Service 49 541 76013 460 nathalie.neumann-knittel[AT]coffee-perfect.de Servicetechniker im Außendienst (m/w/d) Gebiet: • Augsburg / München / Landsberg am Lech Augsburg / München / Landsberg am Lech Vollzeit 01.05.2024 coffee perfect ist mit über 300...
UNITY Consulting and Innovation
Switzerland - Bern
May 9, 2024
UNITY Consulting & Innovation IT Infrastructure Specialist (Senior Level | internal IT department) Berlin, Germany (hybrid) Employee System administration, network administration 65.000 € / year Remote | Germany-wide | Sabbatical options There's a lot to do. • That's why Birk is looking for...
FrischeParadies GmbH and Co KG
Switzerland - Zürich (Kreis 11)
May 11, 2024
Das Beste von allem. • Jeder, der Teil unserer Welt wird, wird auch ein Teil von uns und erfährt, was uns besonders macht. • Was wir sind? Wir sind ein hochprofessioneller, leidenschaftlicher Haufen von foodbegeisterten Persönlichkeiten. • Wir sind bunt, kreativ, lebhaft,...
Switzerland - Zürich (Kreis 11)
March 26, 2024
GELDHAUSER: • WIR BEWEGEN MENSCHEN. • Wir suchen motivierte Mitarbeiter zur Verstärkung unseres Teams mit Interesse für Nutzfahrzeuge und die Bereitschaft, eine abwechslungsreiche Tätigkeit mit Herausforderungen auszuüben. • Wir sind ein zukunftssicheres mittelständisches...
Switzerland - Zürich (Kreis 11)
April 5, 2024
Nathalie Neumann-Knittel Schwerpunkt: • Service 49 541 76013 460 nathalie.neumann-knittel[AT]coffee-perfect.de Servicetechniker im Außendienst (m/w/d) Gebiet: • Augsburg / München / Landsberg am Lech Augsburg / München / Landsberg am Lech Vollzeit 01.05.2024 coffee perfect ist mit über 300...
Switzerland - Aigle
May 21, 2024
Gaznat SA a pour mission générale d'assurer l'approvisionnement de la Suisse occidentale en gaz naturel. • Dans ce contexte, elle est confrontée à des enjeux stratégiques importants et fait face à de nombreux défis en cours notamment dans le domaine des énergies renouvelables et des...
Switzerland - Bern
May 1, 2024
Team Leader IT Infrastructure (m/f/d) Desitin is one of the few medium-sized, family-owned German pharmaceutical companies. • In Hamburg, we develop, produce and distribute pharmaceuticals primarily for the European market. • In particular, Desitin has excellent expertise in the areas of...
Switzerland - Bern
May 21, 2024
Intune Consultant (m/f/d) in device management Permanent position, full-time - Cologne Your tasks The device management team looks after over 120,000 end devices (Windows, macOS, Android, iOS and iPadOS) at various locations, both remotely and on site. • It is responsible for the maintenance,...
KET Karosserie Entwicklung Thurner GmbH
Switzerland - Zürich (Kreis 11)
April 9, 2024
Starte zum 01. • September 2024 Deine Ausbildung an unserem Standort in München als Ausbildung zum Technischen Produktdesiginer (m/w/x) in der Automobilentwicklung (Fachrichtung Produktgestaltung und -konstruktion) Deine Aufgaben: • Während Deiner dreieinhalbjährigen Ausbildungszeit...
Switzerland - Zürich (Kreis 11)
April 20, 2024
Monteur (m/w/d) Telekommunikation für Kabelmontagen für Kupfer- und Glasfaserkabel Vollzeit | Deutschlandweit wie z.B.: • Berlin, Hamburg, Leipzig, Halle, Stuttgart, Dortmund, Frankfurt, München, Nürnberg Steh nicht auf der Leitung, sondern lege sie: • Du suchst einen Arbeitgeber, der...
Switzerland - Bern
May 7, 2024
System Analyst Billing (m/f/d) Your tasks in the team You are the link between product management and the development teams, take up the initial requirements and concretize them to such an extent that the business process can be realized - while observing the rules applicable in the German energy...
Switzerland - Renens VD
May 21, 2024
Réviseurs assistants et Réviseurs-comptables qualifiés • Vous : • avez entre 20 et 35 ans, • disposez d'un CFC d'employé de commerce, d'un brevet, d'un Bachelor ou Master, • avez de solides connaissance en matière de comptabilité et un sens de l'analyse, • disposez si...
Switzerland - Lausanne 25
May 21, 2024
Brokers (H/F) • Êtes-vous prêt(e) à démarrer une carrière enrichissante qui offre de l'autonomie, des perspectives de croissance et l'occasion d'élargir votre réseau ? • Bénéficiant d'une croissance soutenue et stratégique, Beyond Barrel s'impose comme leader dans le négoce de rhums...
Heraeus Consulting and IT Solutions GmbH
Switzerland - Zurich
May 9, 2024
Enterprise Architect (m/f/d) Location Hanau Permanent Full Time About Heraeus Solutions from the Heraeus Group provide faster internet, rid water of germs, and keep hearts beating in time. • As a broadly diversified and globally leading family-owned technology company, we combine materials...
Helvetia Schweizerische Versicherungsgesellschaft AG
Switzerland - Bern
May 19, 2024
Application Developer (m/f/d) Cobol z/OS Application Developer Cobol z/OS (m/f/d) Risk protection, pensions, art, classic cars: • we are excellently positioned in a wide range of insurance sectors. • Always close to people, personally and digitally. • Our team brings tradition and...
Switzerland - Bern
May 1, 2024
Hamburg | Full-time | IT division | Permanent IT Demand Manager (m/f/d) Our aim is to be the best health insurance company in the digital age. • To achieve this, we are constantly developing our IT products and services for our customers. • As an IT Demand Manager, you will be the first...
Mittwald CM Service GmbH and Co KG
Switzerland - Bern
May 9, 2024
Technical support employee - focus on CMS and store systems (m/f/d) in customer service mittwald is 180 creative minds living their dream of Silicon Valley in tranquil Espelkamp. • We live the web. • We breathe code. • And: • We love agencies & freelancers. • As a web host...
Switzerland - Bern
May 8, 2024
Working at Stadtwerke Hennigsdorf means helping to shape the energy future of the town of Hennigsdorf and the region. • Through the municipal district heating supply, the company currently achieves a climate-friendly heat supply of up to 65 percent in Hennigsdorf, and in the next few years this...
Switzerland - Bern
May 6, 2024
Hamburg | Full-time | IT division | Permanent IT Administrator Data Management (m/f/d) The Host Engineering team in the Architecture & Framework department is responsible for the ongoing implementation and further development of data exchange with employers and service providers as well as internal...
Switzerland - Echallens
May 19, 2024
Bienvenue chez Cardis Sotheby's International Realty ! • Courtier en immobilier • Chez Cardis Sotheby's International Realty, nous vous offrons l'opportunité de rejoindre un groupe d'envergure mondiale inégalée. • En intégrant notre structure, vous trouverez une entreprise moderne,...
Switzerland - Zürich (Kreis 11)
April 13, 2024
Wir sind in Kontinentaleuropa die Nr.1 der Golfausrüster. • Ein Erfolg, auf den wir stolz sind. • Und der nicht von ungefähr kommt. • Denn wir teilen etwas mit unseren Kunden: • Leidenschaft. • Die Leidenschaft für einen faszinierenden Sport, die Leidenschaft für die eigene...
Orient Overseas Container Line Ltd Zweigniederlassung Deutschland
Switzerland - Bern
May 2, 2024
To strengthen our team in Hamburg, we are looking for you at the earliest possible date as IT Analyst/Senior Technical Analyst (m/f/d) Infrastructure (Server and Desktop) Accelerate your career Work with the latest technology for cloud and infrastructure services Learn and apply the latest...
Switzerland - Zürich (Kreis 11)
April 5, 2024
Nathalie Neumann-Knittel Schwerpunkt: • Service 49 541 76013 460 nathalie.neumann-knittel[AT]coffee-perfect.de Servicetechniker im Außendienst (m/w/d) Gebiet: • Augsburg / München / Landsberg am Lech Augsburg / München / Landsberg am Lech Vollzeit 01.05.2024 coffee perfect ist mit über 300...