Head of Manufacturing - Biologics

Discover International; Osterwieck; Vor Ort; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

An established industry player is seeking a strategic leader for the Head of Biologics Manufacturing role. This high-impact position involves overseeing all aspects of biologics production, ensuring compliance with stringent regulatory standards while delivering high-quality biopharmaceutical products. The ideal candidate will have a proven track record in GMP environments, strong leadership skills, and experience in scaling operations. This is a unique opportunity to shape and enhance manufacturing capabilities within a dynamic and growing biopharmaceutical organization, offering competitive compensation and a comprehensive benefits package.

Leistungen

Comprehensive benefits package

Competitive compensation

Leadership role in a growing organization

Qualifikationen

• 7+ years in biologics manufacturing, with leadership experience in GMP environments.
• Fluency in German & English is required.

Aufgaben

• Lead biologics manufacturing operations and ensure compliance with global standards.
• Manage a multidisciplinary team and drive operational improvements.

Kenntnisse

Leadership

GMP Compliance

Biologics Production

Regulatory Knowledge

Team Management

Continuous Improvement

Interpersonal Skills

Ausbildung

Bachelor's in Biotechnology

Master's or PhD

Tools

Digital Manufacturing Systems

Chromatography

Single-Use Systems

Jobbeschreibung

Job Title: Head of Biologics Manufacturing

Location: Hesse

Reports to: SVP of Manufacturing

Department: Manufacturing / Operations

Job Type: Full-Time

Position Overview:

Our client is seeking a seasoned and strategic leader for the role of Head of Biologics Manufacturing. This individual will be responsible for overseeing all aspects of biologics manufacturing operations, ensuring the delivery of high-quality biopharmaceutical products in compliance with global regulatory standards. The successful candidate will bring extensive experience in biologics production, strong leadership skills, and a track record of operational excellence in GMP environments.

Key Responsibilities:

• Lead end-to-end biologics manufacturing operations, including upstream, downstream, and fill/finish processes.
• Develop and execute manufacturing strategies aligned with organizational goals and product pipeline milestones.
• Ensure adherence to quality, regulatory, safety, and compliance standards (e.g., FDA, EMA, ICH, cGMP).
• Manage and mentor a multidisciplinary manufacturing team, promoting a high-performance and quality-focused culture.
• Oversee tech transfer, scale-up, and validation activities for new products and processes.
• Collaborate closely with internal stakeholders across Quality, Regulatory, Process Development, Engineering, and Supply Chain.
• Provide leadership during regulatory inspections, audits, and partner due diligence activities.
• Drive operational improvements through continuous improvement initiatives and adoption of innovative technologies.
• Manage budgets, capacity planning, and manufacturing KPIs to support clinical and commercial demands.

Candidate Profile:

• Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, or a related field; advanced degree (MSc, PhD, or MBA) preferred.
• Minimum of 7 years of experience in biologics manufacturing, with at least 3 years in senior leadership roles.
• Proven expertise in GMP biologics production, including experience with technologies such as single-use systems, perfusion, chromatography, and aseptic fill/finish.
• Demonstrated success in leading teams, scaling operations, and supporting tech transfer/commercialization activities.
• Strong knowledge of regulatory requirements and experience managing inspections and audits.
• Excellent interpersonal, leadership, and decision-making skills.
• Experience with digital manufacturing systems and continuous improvement methodologies is an advantage.
• Fluency in both German & English

Why This Role:

• High-impact leadership role within a dynamic and growing biopharmaceutical organization.
• Opportunity to shape and scale biologics manufacturing capabilities to support a robust pipeline.
• Competitive compensation and comprehensive benefits package.

Email applicants: [e-mail]