Production Manager Drug Product

Your tasks

The Production Manager Drug Product at PAION ensures the supply of drug product to meet PAION's commercial requirements from the manufacturing / production perspective.
Establishes, maintains, and improves the Life Cycle Management of production processes (incl. Continuous Process Improvements, Manufacturing Process Validation Master Plan, etc).
Ensures a proper management of the Manufacturing Specifications.

1. Review manufacturing documentation and ensure manufacturing activities are conducted in-time and in accordance with current GMP guidelines, PAION specifications and procedures.
2. Drawing up of Manufacturing Specifications in coordination with relevant departments and CMOs.
3. Support drawing up and review other relevant specifications, e.g. release specifications.
4. Perform Life Cycle Management and Continuous Improvement of manufacturing processes by establishing and executing a manufacturing process validation master plan and follow up of required periodical and ad-hoc measures in cooperation with other departments and CMOs.
5. 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.
6. Ensure overall compliance with ICH requirements, especially ICH Q3, ICH Q7, ICH Q8, ICH Q9, ICH Q11, ICH Q12.
7. Manage Drug Product materials together with Supply Chain and external partners.
8. Manage production related change controls and deviations internally as well as externally with vendors.
9. Provide support to licensees in production related topics where applicable, including the organisation and support of manufacturing process transfer programs.
10. Draw up, review and maintain internal and external production-related documents i.e. validation reports, risk assessments, master and executed batch records, as well as SOPs.
11. Provide technical support with the drawing up and maintenance of registration documentation.
12. General management and control of external vendors as well as the coordination of interactions with these vendors in all production related topics.
13. Provision of subject matter expertise to support audit of manufacturing / testing facilities in accordance with GMP, current guidelines and internal procedures.

Your profile

Post graduate / graduate in Pharmacy, Pharmaceutical Sciences, Chemistry or Life Sciences (at least Master degree or diploma), preferably with a focus on process chemistry.

Professional / Industry Experience:
At least 5 years 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 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.

Language requirements:
English and German.

Why us?

• 30 days 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 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.