Manufacturing Leader - Parenterals (m/w/d)

Real; Mannheim; Vor Ort; EUR 120.000 - 180.000; Vollzeit

Zusammenfassung

Real leads a highly specialised pharmaceutical manufacturing environment focused on sterile investigational medicines in a GMP-regulated setting. The role combines leadership, aseptic manufacturing expertise and scientific collaboration to support global development programmes.

As Manufacturing Leader, you will oversee sterile operations, ensure compliant records, and drive improvements across quality systems.

Qualifikationen

• Several years of experience in GMP-regulated pharmaceutical manufacturing.
• Experience in sterile manufacturing, aseptic processing, injectables or parenteral production.
• Leadership with direct people management responsibility.
• Fluency in German and English.
• Experience with investigations, deviations, CAPA, validation and qualification.

Aufgaben

• Leading GMP-compliant manufacturing operations for sterile and parenteral products.
• Ensuring compliant execution of manufacturing activities in accordance with regulations and quality standards.
• Reviewing and approving manufacturing records and GMP documentation.
• Evaluating and approving deviations, investigations, CAPA measures, validation and qualification activities.
• Supporting contamination control strategies and aseptic manufacturing excellence.
• Leading aseptic process simulations and sterility assurance activities.
• Ensuring readiness for internal audits and regulatory inspections.
• Driving continuous improvement initiatives within manufacturing processes and quality systems.
• Contributing to equipment implementation, facility upgrades and process optimisation projects.
• Collaborating with Development, Quality, Engineering and Supply Chain functions.
• Leading, developing and coaching manufacturing teams.

Kenntnisse

Leadership

Sterile manufacturing

Aseptic processing

Quality systems

Regulatory compliance

Cross-functional collaboration

Process improvement

Ausbildung

Degree in Pharmacy/Pharmaceutical Sciences/Biotech/Chemistry/Engineering

Jobbeschreibung

You will join a highly specialised pharmaceutical manufacturing environment responsible for producing sterile investigational medicines that support global development programmes. Operating within a GMP-regulated setting, you will play a key role in ensuring that innovative therapies are manufactured safely, consistently and in accordance with the highest quality standards.

This position offers the opportunity to combine leadership, aseptic manufacturing expertise and scientific collaboration in an environment where manufacturing directly contributes to future medicines.

Your Responsibilities

As a manufacturing leader, you will take operational responsibility for sterile manufacturing activities and support the legally required manufacturing function within a regulated pharmaceutical environment.

Key responsibilities include:

• Leading GMP-compliant manufacturing operations for sterile and parenteral products
• Ensuring compliant execution of manufacturing activities in accordance with applicable regulations and company quality standards
• Reviewing and approving manufacturing records and associated GMP documentation
• Evaluating and approving deviations, investigations, CAPA measures, validation and qualification activities
• Supporting contamination control strategies and aseptic manufacturing excellence
• Leading and overseeing aseptic process simulations and related sterility assurance activities
• Ensuring readiness for internal audits and regulatory inspections
• Driving continuous improvement initiatives within manufacturing processes and quality systems
• Contributing to equipment implementation, facility upgrades and process optimisation projects
• Collaborating closely with Development, Quality, Engineering and Supply Chain functions
• Leading, developing and coaching manufacturing teams

What You Bring

We are interested in professionals who combine strong manufacturing leadership with a solid understanding of pharmaceutical quality and compliance.

Preferred Qualifications

• Degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, Chemistry, Engineering or a comparable scientific discipline
• Several years of experience within a GMP-regulated pharmaceutical manufacturing environment
• Proven experience in sterile manufacturing, aseptic processing, biologics, injectables, fill-finish operations or parenteral production
• Leadership experience with direct people management responsibility
• Strong understanding of EU GMP requirements and pharmaceutical manufacturing regulations
• Experience with investigations, deviations, CAPA, process validation and qualification activities
• Experience acting within the manufacturing organisation in accordance with §12 AMWHV (Leitung der Herstellung)
• Exposure to regulatory inspections and audit preparation
• Fluency in German and English

What Makes This Opportunity Unique

• Direct impact on the development of future therapies
• High level of responsibility within a GMP-regulated environment
• Exposure to innovative pharmaceutical technologies and manufacturing processes
• Collaboration with international multidisciplinary teams
• Opportunities to influence manufacturing strategy, process improvements and operational excellence
• Leadership role combining science, quality and manufacturing

If you are passionate about sterile pharmaceutical manufacturing and enjoy operating at the intersection of compliance, innovation and leadership, this opportunity offers a platform to make a meaningful contribution to the future of healthcare.