Production Manager Drug Product
vor 1 Monat
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, Manufacturing Process Validation Master Plan, and more.
- 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, as well as 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, as well as manage production-related change controls and deviations internally and 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, and SOPs.
- Provide technical support with the drawing up and maintenance of registration documentation and general management and control of external vendors, as well as 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 degree 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.
- 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, headquartered in Aachen, Germany, is a specialty pharmaceutical company in the field of anesthesia and critical care specializing in innovative active pharmaceutical ingredients for use in outpatients and hospitals.
PAION Pharma GmbH is part of the Humanwell Healthcare Group.
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