Production Manager Pharma for Commercial Drug Product (m/f/d)

PAION AG; Aachen; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

30 days vacation (full time)

Flexible working hours with partialホーム

Modern office near A44

Zusammenfassung

PAION AG in Aachen is seeking an experienced Production Manager Pharma (m/f/d) to serve as the Subject Matter Expert for drug product manufacturing. You will collaborate with CMOs, QA, Regulatory Affairs and partners to ensure reliable, compliant commercial production.

The role requires a degree in Pharmacy/Pharmaceutical Sciences or Chemistry/Life Sciences and at least 5 years in the pharma/biotech sector, with strong GMP knowledge and international collaboration skills.

Qualifikationen

• University degree in Pharmacy, Pharmaceutical Sciences, Chemistry or Life Sciences.
• Deep GMP knowledge including ICH guidelines and EU/US requirements.
• At least 5 years of professional experience in the pharmaceutical/biotech industry.
• Experience working with CMOs and external manufacturing partners.
• Strong communication and collaboration in an international environment.

Aufgaben

• Act as SME for PAION’s drug product manufacturing.
• Coordinate interaction with CMOs involved in PAION’s drug products.
• Review manufacturing documentation and ensure GMP/ICH/compliance.
• Manage deviations, change controls, risk assessments and validation activities.
• Support process validation, lifecycle management and continuous improvement.
• Maintain and improve manufacturing processes including EU GMP updates.
• Provide SME support to licensees and organize transfer programs.
• Work with Regulatory Affairs for technical input on submissions.
• Assist GMP audits and inspections as manufacturing SME.

Kenntnisse

GMP knowledge

Cross-functional teamwork

International collaboration

Quality assurance

Ausbildung

Pharmacy/Pharmaceutical Sciences

Chemistry

Life Sciences

Jobbeschreibung

Your tasks

We are looking for an experienced and motivated Production Manager Pharma (m/f/d) who combines strong technical expertise with a pragmatic, solution-oriented approach to join our team in Aachen. In this role, you will be the Subject Matter Expert (SME) for drug product manufacturing and ensure that our commercial manufacturing activities are performed reliably, on time and in compliance with applicable GMP requirements. You will work closely with or Contract Manufacturing Organizations (CMOs) as well as Quality Assurance, Regulatory Affairs and other internal and external partners.

Your Responsibilities

• Act as the Subject Matter Expert (SME) for all aspects of PAION’s drug product manufacturing activities


• Manage and coordinate the interaction with Contract Manufacturing Organizations (CMOs) involved in the manufacture of PAION’s drug products


• Review manufacturing documentation, including Master Batch Records, and ensure compliance with current GMP requirements, relevant ICH guidelines, PAION specifications and internal procedures


• Manage production-related deviations, change controls, risk assessments and validation activities


• Support process validation, lifecycle management and continuous improvement of manufacturing processes


• Review, maintain and continuously improve manufacturing processes, including implementation of changes resulting from updates to EU GMP and other applicable international GMP requirements


• Provide production-related SME support to licensees, including the organization and execution of manufacturing process transfer programs.


• Work in close cooperation with the Regulatory Affairs team and provide technical input for the preparation, review and maintenance of regulatory documentation and submissions


• Support GMP audits and inspections as the manufacturing SME expertise

Your profile

• University degree or postgraduate qualification in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences or a comparable scientific discipline


• In-depth knowledge of GMP, including relevant ICH guidelines and applicable national and international EU / US requirements


• At least 5 years of professional experience in the pharmaceutical or biotechnology industry


• Solid experience in one or more of the following areas:
  
  
  • Commercial manufacturing and on-time production of APIs and/or drug products, ideally sterile products and/or injectables, in collaboration with Quality Assurance
  
  
  • Managing deviations and change controls
  
  
  • Process validation
  
  


• Experience in working with CMOs and other external manufacturing partner


• Strong communication and collaboration skills in an international environment


• Knowledge of national regulatory and GMP requirements in Asian markets, particularly Japan, South Korea and/or China is an advantage

Interested?

If you are ready to take responsibility for the manufacturing of innovative pharmaceutical products and want to contribute your expertise to an international, growing organization, we look forward to meeting you!

Why us?

• 30 days vacation (full time) and additional benefits


• Short communication channels, open doors and helpful, committed colleagues


• Flexible working hours with partial home office (max. 2 days/week)


• Modern office building with underground parking spaces in a location close to the A44 motorway

PAION contact details

For further information please visit our website: www.paionpharma.com