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Head of manufacturing - biologics

Niederdorla
Discover International
Manager
Inserat online seit: 7 Juni
Beschreibung

Get AI-powered advice on this job and more exclusive features.Direct message the job poster from Discover InternationalSenior Consultant | Quality & Tech Ops | Pharma & BiotechJob Title: Head of Biologics ManufacturingLocation: HesseReports to: SVP of ManufacturingDepartment: Manufacturing / OperationsJob Type: Full-TimePosition 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: Jake.tookey@discoverinternational.comSeniority levelDirectorEmployment typeFull-timeJob functionManagement, Manufacturing, and ProductionIndustriesPharmaceutical Manufacturing, Biotechnology Research, and Chemical Manufacturing #J-18808-Ljbffr

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