Your tasks
We are looking for a Production Manager Drug Product (m/f/d) to join our team in Aachen to ensure that the manufacturing of our drug products meets our commercial requirements from the manufacturing / production perspective.
Responsibilities / Main Tasks
- Become the Subject Matter Expert (SME) for all aspects of PAIONs Drug Product manufacturing activities.
- Manage the interaction with PAIONs drug product CMOs as the SME
- Review manufacturing documentation (Master Batch Records) and ensure manufacturing activities are conducted in-time and in accordance with current GMP guidelines, relevant ICH requirements, PAION specifications and procedures.
- Perform and support Life Cycle Management and Continuous Improvement of manufacturing processes including process validation activities
- 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.
- Manage production related change controls and deviations as well as validation reports and risk assessments
- Provide support to licensees as SME in production related topics where applicable, including the organization and support of manufacturing process transfer programs
- Provide technical support with the writing and maintenance of registration documentation
- Provision of subject matter expertise to support audit of manufacturing / testing facilities in accordance with GMP, current guidelines and internal procedures.
Your profile
- Postgraduate / graduate in Pharmacy, Pharmaceutical Sciences, Chemistry or Life Science
- At least 5 years in pharmaceutical or biotechnology industry; preferably with experience in areas such as manufacturing of drug products (preferably with steriles and injectables), process chemistry, process development and validation and manufacturing process lifecycle management within manufacturing of pharmaceutical products
- Deep-rooted knowledge of GMP, including ICH requirements and national EU / US requirements
- Proven knowledge of / experience in: Commercial manufacturing and on-time manufacture of drug products as technical expert in cooperation with a QA team
- Managing change controls and deviations
- Process validation
- Beneficial experience: Technical management and direction of external vendors
- Manufacturing of sterile products / injectables
- Knowledge of national regulatory requirements for Asian countries (e.g. Japan, Korea, China)
Why us?
- 30 days vacation (full time)
- Short communication channels, open doors and helpful, committed colleagues
- Flexible working hours with partial home office (2 days/week) for a healthy work-life balance
- Company supplementary health insurance and pension scheme
- Modern office building with underground parking spaces in a location close to the A44 motorway
PAION contact details
Do you want to work in an international and dynamic environment and would like to play an active role?
We look forward to receiving your application preferably by email, at recruiting@paion.com.
If you have any questions, you can send us an email to HR@paion.com.
For further information please visit our website: www.paionpharma.com
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About us
PAION Pharma GmbH, headquartered in Aachen, Germany, 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 Humanwelll Healthcare Group.
www.paionpharma.com
