Production Manager Drug Product
vor 4 Wochen
We 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 Responsibilities- Establish, maintain, and improve the Life Cycle Management of production processes, including Continuous Process Improvements and Manufacturing Process Validation Master Plan.
- Review manufacturing documentation and ensure manufacturing activities are conducted in-time and in accordance with current GMP guidelines, PAION specifications, and procedures.
- Draw up and review Manufacturing Specifications in coordination with relevant departments and CMOs.
- 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.
- 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 organization 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.
- 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.
- Process validation and commercial manufacturing.
- Risk Management.
- Beneficial:
- Knowledge of additional national regulatory requirements outside EU/US (e.g., Japan, Korea, Brazil) as well as their national GMP and manufacturing requirements.
- Experience of technical management and direction of external vendors would be extremely beneficial as the company works with a network of vendors.
- Manufacturing of sterile products/injectables.
English and German
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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...
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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...
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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...
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