Production Manager
vor 3 Wochen
We are seeking a highly skilled Production Manager to join our team at PAION Pharma GmbH. The successful candidate will be responsible for ensuring the supply of drug product to meet our commercial requirements from a manufacturing perspective.
Key Responsibilities- Establish, maintain, and improve the Life Cycle Management of production processes, including Continuous Process Improvements and Manufacturing Process Validation Master Plan.
- Ensure proper management of Manufacturing Specifications and review manufacturing documentation to ensure activities are conducted in-time and in accordance with current GMP guidelines and PAION specifications.
- Draw up and review Manufacturing Specifications in coordination with relevant departments and CMOs, and support the drawing up and review of other relevant specifications.
- Perform Life Cycle Management and Continuous Improvement of manufacturing processes by establishing and executing a manufacturing process validation master plan and following up on required periodical and ad-hoc measures in cooperation with other departments and CMOs.
- Review and update/improve manufacturing processes as appropriate, including changes/updates of EU GMP guidelines and GMP guidelines of other territories in the interest of PAION.
- Ensure overall compliance with ICH requirements, especially ICH Q3, ICH Q7, ICH Q8, ICH Q9, ICH Q11, and ICH Q12.
- Manage Drug Product materials together with Supply Chain and external partners, and manage production-related change controls and deviations internally as well as externally with vendors.
- Provide support to licensees in production-related topics where applicable, including the organisation and support of manufacturing process transfer programs.
- Draw up, review, and maintain internal and external production-related documents, such as validation reports, risk assessments, master and executed batch records, as well as SOPs.
- Provide technical support with the drawing up and maintenance of registration documentation, and general management and control of external vendors as well as the coordination of interactions with these vendors in all production-related topics.
- Provision of subject matter expertise to support audit of manufacturing/testing facilities in accordance with GMP, current guidelines, and internal procedures.
- Postgraduate/graduate in Pharmacy, Pharmaceutical Sciences, Chemistry, or Life Sciences (at least Master degree or diploma), preferably with a focus on process chemistry.
- At least 5 years of practical industrial experience working in pharmaceutical or biotechnology industries and in three or more of the following areas associated with industrialization and manufacturing of pharmaceutical products: process chemistry, process development and validation, manufacturing of Drug Products, manufacturing process lifecycle management, quality control.
- Deep-rooted knowledge of GMP requirements and national EU/US regional requirements.
- Proven knowledge of/experience in GMP and working within a Quality Management System, managing change controls, deviations, commercial manufacturing, and on-time manufacture of drug products as a technical expert in cooperation with a QA team.
- Risk Management.
- 30 days of vacation (full-time).
- Short communication channels, open doors, and helpful, committed colleagues.
- Flexible working hours for a good work-life balance.
- State-of-the-art IT equipment with Dell equipment and Apple iPhones.
- New office facilities with employee showers for athletes and underground parking spaces in Aachen in a very good location directly on the A44 freeway.
PAION Pharma GmbH is a specialty pharmaceutical company in the field of anaesthesia and critical care, specialising in innovative active pharmaceutical ingredients for use in outpatients and hospitals.
PAION Pharma GmbH is part of the Humanwell Healthcare Group.
-
Production Manager Drug Product
vor 3 Wochen
Aachen, Nordrhein-Westfalen, Deutschland PAION Pharma GmbH VollzeitAbout the RoleThe Production Manager Drug Product at PAION Pharma GmbH is responsible for ensuring the supply of drug product to meet commercial requirements from a manufacturing perspective. This involves establishing, maintaining, and improving the Life Cycle Management of production processes, including Continuous Process Improvements and Manufacturing...
-
Production Manager Drug Product
vor 1 Monat
Aachen, Nordrhein-Westfalen, Deutschland PAION Pharma GmbH VollzeitAbout the RoleWe are seeking a highly skilled Production Manager Drug Product to join our team at PAION Pharma GmbH. As a key member of our production team, you will be responsible for ensuring the supply of drug product to meet our commercial requirements from a manufacturing perspective.Key ResponsibilitiesEstablish, maintain, and improve the Life Cycle...
-
Production Manager Drug Product
vor 1 Monat
Aachen, Nordrhein-Westfalen, Deutschland PAION Pharma GmbH VollzeitAbout the RoleWe are seeking a highly skilled Production Manager Drug Product to join our team at PAION Pharma GmbH. As a key member of our production team, you will be responsible for ensuring the supply of drug product to meet our commercial requirements from a manufacturing perspective.Key ResponsibilitiesEstablish, maintain, and improve the Life Cycle...
-
Production Manager Drug Product
vor 4 Wochen
Aachen, Nordrhein-Westfalen, Deutschland PAION Pharma GmbH VollzeitAbout the RoleWe are seeking a highly skilled Production Manager Drug Product to join our team at PAION Pharma GmbH. As a key member of our production team, you will be responsible for ensuring the supply of drug product to meet our commercial requirements from a manufacturing perspective.Key ResponsibilitiesEstablish, maintain, and improve the Life Cycle...
-
Production Manager
vor 3 Wochen
Aachen, Nordrhein-Westfalen, Deutschland PAION Pharma GmbH VollzeitAbout the RoleThe Production Manager - Drug Product at PAION Pharma GmbH is responsible for ensuring the supply of drug product to meet commercial requirements from a manufacturing perspective. This involves establishing, maintaining, and improving life cycle management of production processes, including continuous process improvements and manufacturing...
-
Production Manager Drug Product
vor 4 Wochen
Aachen, Nordrhein-Westfalen, Deutschland PAION Pharma GmbH VollzeitJob SummaryWe are seeking a highly skilled Production Manager Drug Product to join our team at PAION Pharma GmbH. As a key member of our production team, you will be responsible for ensuring the supply of drug product to meet our commercial requirements from the manufacturing/production perspective.Key ResponsibilitiesEstablish, maintain, and improve the...
-
Production Manager Drug Product
vor 4 Wochen
Aachen, Nordrhein-Westfalen, Deutschland PAION Pharma GmbH VollzeitJob SummaryWe are seeking a highly skilled Production Manager Drug Product to join our team at PAION Pharma GmbH. As a key member of our production team, you will be responsible for ensuring the supply of drug product to meet our commercial requirements from the manufacturing/production perspective.Key ResponsibilitiesEstablish, maintain, and improve the...
-
Aachen, Nordrhein-Westfalen, Deutschland Fraunhofer-Gesellschaft VollzeitAt Fraunhofer IPT, we're pushing the boundaries of production technology. As a researcher, you'll delve into the world of AI management systems, exploring their potential to revolutionize production processes. Your work will focus on designing and implementing management systems that can effectively manage AI applications in production, ensuring compliance...
-
Senior Semiconductor Fabrication Manager
vor 1 Woche
Aachen, Nordrhein-Westfalen, Deutschland Project A Ventures VollzeitWe are seeking a highly skilled Fabrication Director to lead our semiconductor foundry and oversee the planning, installation, and ramp-up phase of a pilot fab for a new photonic semiconductor technology.Key Responsibilities:Plan and establish a new 300 mm pilot production site for a novel photonic technology integrated in backend of CMOS electronics.Ramp up...
-
Senior Fabrication Manager
vor 4 Wochen
Aachen, Nordrhein-Westfalen, Deutschland Project A Ventures VollzeitAbout the RoleWe're seeking an experienced Fabrication Director to lead our semiconductor foundry and drive the planning, installation, and ramp-up of a pilot fab for a new photonic semiconductor technology. The ideal candidate will have a strong background in semiconductor manufacturing facility planning, construction, startup, and operation, including...
-
Senior Project Manager
vor 4 Wochen
Aachen, Nordrhein-Westfalen, Deutschland Cognex Vollzeit{"The Company": "Cognex is a global leader in machine vision, with a strong financial position and a culture that values innovation and creativity. Our employees, known as Cognoids, take their work seriously but don't take themselves seriously. We maintain a fast-paced and creative environment that recognizes employee innovation, perseverance, and hard work...
-
Senior Project Manager
vor 4 Wochen
Aachen, Nordrhein-Westfalen, Deutschland Cognex Vollzeit{"The Company": "Cognex is a global leader in machine vision, with a strong financial position and a culture that values innovation and creativity. Our employees, known as Cognoids, take their work seriously but don't take themselves seriously. We maintain a fast-paced and creative environment that recognizes employee innovation, perseverance, and hard work...
-
Business Development Manager
vor 4 Wochen
Aachen, Nordrhein-Westfalen, Deutschland LenioBio GmbH VollzeitAbout LenioBio GmbHLenioBio GmbH is a pioneering biotechnology company that is revolutionizing the production of complex proteins. Our groundbreaking ALiCE technology enables the rapid, scalable, and efficient production of complex proteins that are at the forefront of medical innovation.Job DescriptionWe are seeking a seasoned Business Development or...
-
Business Development Manager
vor 4 Wochen
Aachen, Nordrhein-Westfalen, Deutschland LenioBio GmbH VollzeitAbout LenioBio GmbHLenioBio GmbH is a pioneering biotechnology company that is revolutionizing the production of complex proteins. Our groundbreaking ALiCE technology enables the rapid, scalable, and efficient production of complex proteins that are at the forefront of medical innovation.Job DescriptionWe are seeking a seasoned Business Development or...
-
Senior Project Manager
vor 3 Wochen
Aachen, Nordrhein-Westfalen, Deutschland Cognex VollzeitAbout the Role:Cognex is the global leader in machine vision, with a strong financial position and a culture that maintains a fast-paced, creative environment. We are seeking a skilled Senior Project Manager to join our Operations New Product Introduction (NPI) team.Key Responsibilities:Develop schedules and manage milestones for assigned products within...
-
Senior Project Manager
vor 2 Wochen
Aachen, Nordrhein-Westfalen, Deutschland Cognex VollzeitThe Opportunity:Cognex is a financially strong international company with a culture that maintains the fast-paced, creative environment of a startup. We are seeking a Senior Project Manager to join our Operations team in achieving the cost, quality, and delivery requirements of our customers globally.The Role:The Senior Project Manager will be responsible...
-
Senior Project Manager
vor 3 Wochen
Aachen, Nordrhein-Westfalen, Deutschland Cognex VollzeitAbout the Role:Cognex is a global leader in machine vision, and we're seeking a skilled Senior Project Manager to join our Operations team. As a key member of our New Product Introduction (NPI) team, you'll be responsible for developing schedules, managing milestones, and driving cross-functional global resources to achieve key performance metrics for...
-
Product Manager and Product Owner
vor 3 Wochen
Aachen, Nordrhein-Westfalen, Deutschland Utimaco VollzeitYour RoleAs a Product Manager and Product Owner at Utimaco, you will be responsible for managing the entire product lifecycle of our hardware platforms, including PCIe HSMs, appliances, and other form factors. Your goal will be to maximize benefits for the company by collecting requirements, setting strategy, managing implementation, and related technical...
-
Fabrication Director
vor 2 Wochen
Aachen, Nordrhein-Westfalen, Deutschland Project A Ventures VollzeitAbout the JobWe're seeking a seasoned Fabrication Director to lead the semiconductor foundry for one of our portfolio companies. This role involves collaborating with an experienced fab team during the planning, installation, and ramp-up phase of a pilot fab for a new photonic semiconductor technology. The ideal candidate will have a strong background in...
-
Senior Project Manager
vor 4 Wochen
Aachen, Nordrhein-Westfalen, Deutschland Cognex VollzeitAbout CognexCognex is a global leader in machine vision, with a strong financial position and a culture that values innovation and hard work.The TeamThe Operations organization at Cognex is responsible for achieving customer requirements globally, partnering with multiple business units for product design and development.The RoleThis Program Manager will...
