Director Global Manufacturing and Cmc
vor 5 Monaten
**Director Global Manufacturing and CMC (f/m/x)**:
**PhD and HQ-Can do-experience are requested**:
***YOUR FUTURE ROLE**:
- Lead and improve manufacturing capabilities for the autologous cancer vaccine production according to GMP requirements
- Lead, improve and redefine CMC aspects for the characterization of the product fulfilling regulatory requirements
- Improve in cross-functional execution and alignment regarding CMC aspects of the products in line with regulatory requirements (EMA and FDA)
- Establish and execute all CMC related activities across functions (research, pre-clinical / bioanalytics and clinical)
- Lead and drive collaborations with external partners including contract manufacturer and bioanalytic departments
- According to company´s need establish new manufacturing sites including manufacturing sites in the US
***JOB REQUIREMENTS**:
- Degree in Life Science (PhD)
- Minimum of 10+experience in manufacturing and CMC from HQs
- Experience in global roll-out of manufacturing capabilities
- Experience in establishing CMC strategy for biologic and / or cell-derived products
- Profound knowledge of regulatory requirements and guidelines (must have)
- Profound knowledge and experience in manufacturing fulfilling GMP requirements (must have)
- _ Background in immunology and vaccine development_
- Excellent communication and leadership capabilities
- High level English skills (oral / written) are requested
- Strong, mature, hands-on leader with convincing decision-making, negotiating, and influencing skills
- Driven teamplayer and individual performer according to needs, ready to work and to develop again in a dynamic biotech setting
- You are a bold, curious, goal-oriented, result and mission-driven, entrepreneurial-minded RA-professional equipped with strong analytical skills
***OUR CLIENT OFFERS**:
- Open, dynamic and positive, diverse company culture with short decision-making and freedom to operate - offering an expert-context to set your individual footprint
- A meaningful position aimed at significantly improving the clinical outcome and quality of life for cancer patients
- Smart working
***ARE YOU INTERESTED?**:
-
Wien, Wien, Österreich Takeda VollzeitJob SummaryWe are seeking a highly skilled Head of Digital CMC Transformation and Sustainability Lead to join our team at Takeda. In this role, you will lead the strategic integration of sustainability and digital innovation within the Chemistry, Manufacturing, and Controls (CMC) function.About the Role:You will be responsible for championing our "In Silico...
-
CMC Lead
vor 1 Monat
Wien, Wien, Österreich AOP Orphan VollzeitAOP Health is a pioneer in integrated therapies for rare diseases and critical care. We are seeking a CMC Lead to join our team in Vienna. The successful candidate will be responsible for leading outsourced pharmaceutical development and life cycle activities, representing CMC in product development and optimization projects, and providing CMC input in due...
-
Wien, Wien, Österreich Takeda Manufacturing Austria AG VollzeitTakeda Manufacturing Austria AG is at the forefront of a rapidly evolving industry where technology and data are revolutionizing manufacturing and supply chains.Main Responsibilities:Develop and implement innovative solutions to drive business growth and improve operational efficiency.Collaborate with cross-functional teams to stay ahead in the market and...
-
Global Manufacturing and Supply Operations Leader
vor 2 Wochen
Wien, Wien, Österreich Takeda Manufacturing Austria AG VollzeitAbout TakedaTakeda is a rapidly transforming industry that's applying technology and data in new ways. Our agile, innovative, people-centric organization offers the opportunity to make a meaningful impact every day.Job SummaryWe are seeking an experienced Senior Project Manager for our Global Manufacturing and Supply team at Takeda Manufacturing Austria AG....
-
Director Global Regulatory Affairs
vor 5 Monaten
Wien, Österreich Talentor Sweden AB Vollzeit**Director Global Regulatory Affairs (f/m/x)**: **PhD and HQ-Can do-experience are requested**: ***YOUR FUTURE ROLE**: - Lead, improve and redefine regulatory strategy and activities for all areas of product development (pre-clinical, CMC and manufacturing and clinical) - Drive in cross-functional execution and alignment - Establish and execute all...
-
Senior Project Manager
Vor 2 Tagen
Wien, Wien, Österreich Takeda Manufacturing Austria AG VollzeitAt Takeda Manufacturing Austria AG, we are seeking an experienced Senior Project Manager to lead our Global Manufacturing and Supply (GMS) team. As a key member of this rapidly transforming industry, you will be part of a dynamic team that's applying technology and data in new ways.About the RoleThis is a senior leadership position responsible for overseeing...
-
Manufacturing Operations Director
Vor 3 Tagen
Wien, Wien, Österreich Valneva VollzeitCompany OverviewWe are a specialty vaccine company dedicated to developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases addressing unmet medical needs.With a strong vision to make an impact in the world, we have leveraged our expertise and capabilities to commercialize three vaccines, including the world's first and only...
-
Global Manufacturing Lead
vor 2 Wochen
Wien, Wien, Österreich Takeda Manufacturing Austria AG VollzeitWe're seeking a seasoned Senior Project Manager to join our Global Manufacturing and Supply team at Takeda Manufacturing Austria AG. As part of this rapidly transforming industry, you'll apply technology and data in innovative ways.About TakedaTakeda is a leading player in the pharmaceutical industry, driven by a passion for innovation and a commitment to...
-
External Manufacturing Director
vor 1 Monat
Wien, Wien, Österreich Valneva VollzeitJob Title: External Manufacturing ManagerWe are a leading vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.ResponsibilitiesAct as the single point of technical contact for assigned External Partners and internal supporting departments at manufacturing sites.Lead daily...
-
Global Talent Development Director
Vor 2 Tagen
Wien, Wien, Österreich Otis College of Art and Design VollzeitAbout UsAt Otis, we are a world-leading elevator and escalator manufacturing company with a strong presence in over 200 countries. We are committed to providing innovative solutions that meet the diverse needs of our customers.Career OpportunitiesWe are currently seeking a Global Talent Development Director to join our team. This role will be based in...
-
Account Executive
vor 6 Monaten
Wien, Österreich CMC Markets VollzeitSince launching in 1989, CMC Markets has become one of the world's leading online CFD and financial spread betting providers, with nearly 70 million trades executed annually across Europe, Asia Pacific and North America. CMC Markets’ success is founded on its ability to deliver a wide range of trading products to customers, from single equities to...
-
Manufacturing and Supply Chain Executive
vor 2 Wochen
Wien, Wien, Österreich Takeda Manufacturing Austria AG VollzeitWe're seeking a talented individual to join our Global Manufacturing and Supply (GMS) team at Takeda in Austria. As a Senior Project Manager, Capex, you'll be part of a rapidly transforming industry that's applying technology and data in new ways.Company OverviewTakeda is a leading global pharmaceutical company with a presence in over 80 countries. Our...
-
Wien, Wien, Österreich Takeda Manufacturing Austria AG VollzeitAs a Strategic Engineering Project Manager, you will play a key role in driving innovation and excellence in the Global Manufacturing team at Takeda Manufacturing Austria AG. We are seeking an experienced professional to lead and manage engineering operations within the organization.This is an exciting opportunity for a seasoned project manager to oversee...
-
CMC Lead
vor 12 Stunden
Wien, Wien, Österreich AOP Orphan VollzeitAOP Health is a pioneer in integrated therapies for rare diseases and critical care. To enhance our team in Vienna, we seek a skilled CMC Lead. This full-time role offers personal responsibility and opportunities for creativity.Your Daily ResponsibilitiesYou will lead outsourced pharmaceutical development activities, overseeing life cycle operations and...
-
Cmc Lead
vor 6 Monaten
Wien, Österreich AOP Orphan Pharmaceuticals GmbH VollzeitFulltime Vienna AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care. To enhance our team in Vienna we are looking for a CMC Lead (f/m/d). **What Your Day To Day Will Look Like**: - Responsible for process, product and analytical development and life cycle management - Support continuous improvement in the...
-
Senior Vaccine Manufacturing Specialist
Vor 3 Tagen
Wien, Wien, Österreich Valneva VollzeitWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.Our team in Vienna is looking for a Senior External Manufacturing Manager to join us in our mission to protect people from infectious diseases. If you have experience in large-scale commercial...
-
Associate Director Global Trade Compliance
vor 4 Wochen
Wien, Österreich Organon Vollzeit**The position** Reporting into the Director Global Logistics Services, as a Global Trade Compliance Associate Director you will be responsible for developing, implementing, and driving Organon’s end-to-end trade compliance program, including overseeing import and export trade activities in the regions. You will manage a team of 4 Senior Specialists and...
-
Drug Product Manufacturing and Fill
vor 1 Woche
Wien, Wien, Österreich Valneva VollzeitWe are seeking a highly skilled Drug Product Manufacturing and Fill & Finish Scientist to join our team at Valneva, a specialty vaccine company. As a key member of our technical development team, you will support the development of early-stage, late-stage, and commercial manufacturing of our vaccine candidates and commercial products.Key...
-
Biotech Manufacturing Director
Vor 2 Tagen
Wien, Wien, Österreich Valneva VollzeitAt Valneva, we are dedicated to developing and commercializing prophylactic vaccines for infectious diseases.We have successfully leveraged our expertise to commercialize three vaccines, including the world's first chikungunya vaccine, and advance a range of vaccine candidates into and through clinical trials, addressing unmet medical needs in areas such as...
-
External Manufacturing Director
vor 2 Wochen
Wien, Wien, Österreich Valneva VollzeitAt Valneva, we are looking for a seasoned External Manufacturing Manager to join our team in Vienna. In this role, you will collaborate with internal departments such as R&D, Clinical, Quality and Supply Chain to oversee and manage the manufacturing of Clinical Trial Materials (CTM) through external partners and Contract Development and Manufacturing...