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External Manufacturing Manager(m/w/x)
Leading virtual plant teams, managing contract manufacturing and lab partners for rare disease biopharmaceuticals. 5 years pharma/life science industry experience, direct CMO/CLO management required. Work in specialized rare disease biopharma, leading virtual plant teams.
Anforderungen
- University degree in Manufacturing, Supply Chain, or relevant field
- Minimum 5 years’ experience in pharmaceutical or life science industry
- At least 2 years’ experience in coordinating roles, including project management
- Hands-on experience with digital systems and good knowledge of MS Office
- Previous experience working directly with CMOs, CLOs, or external partners
- Strong understanding of cGMP manufacturing of biologics and/or small-molecule pharmaceuticals
- Ability to thrive in a cross-functional, matrixed, and global environment
- Excellent verbal and written English communication skills
- Excellent verbal and written Swedish
- Verbal and written skills in Chinese or Japanese is highly desired
- Negotiation skills
Aufgaben
- Lead cross-functional Virtual Plant Teams
- Act as the main point of contact for assigned CMOs and CLOs
- Drive strategic and operational management of CMOs and CLOs
- Conduct Business Reviews and Operational Meetings
- Manage supplier relationships and ensure compliance with supply agreements
- Oversee change orders and improvements for OTIF delivery
- Participate in sourcing and evaluating new contract manufacturers
- Develop supply and quality agreements
- Contribute to internal activities related to external manufacturing
- Manage change management and critical deviations
- Oversee CAPAs and related processes
- Issue, review, and approve relevant SOPs and manufacturing instructions
- Review applicable sections of APR and PQR
- Provide budget input for CMO and CLO-related costs
- Ensure adherence to budget for external manufacturing activities
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Schwedisch – verhandlungssicher
- Chinesisch – Grundkenntnisse
- Japanisch – Grundkenntnisse
Tools & Technologien
- MS Office
Benefits
Attraktive Vergütung
- Competitive compensation
Familienfreundlichkeit
- Emphasis on work/life balance
Lockere Unternehmenskultur
- Collaborative and team-oriented environment
Karriere- und Weiterentwicklung
- Opportunities for professional growth
Sonstige Vorteile
- Diversity and Inclusion
Sinnstiftende Arbeit
- Positive impact on ultra-rare disease patients
Noch nicht perfekt?
- SobiVollzeitmit HomeofficeSeniorBasel
- BeOne Medicines I GmbH
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External Manufacturing Manager(m/w/x)
Leading virtual plant teams, managing contract manufacturing and lab partners for rare disease biopharmaceuticals. 5 years pharma/life science industry experience, direct CMO/CLO management required. Work in specialized rare disease biopharma, leading virtual plant teams.
Anforderungen
- University degree in Manufacturing, Supply Chain, or relevant field
- Minimum 5 years’ experience in pharmaceutical or life science industry
- At least 2 years’ experience in coordinating roles, including project management
- Hands-on experience with digital systems and good knowledge of MS Office
- Previous experience working directly with CMOs, CLOs, or external partners
- Strong understanding of cGMP manufacturing of biologics and/or small-molecule pharmaceuticals
- Ability to thrive in a cross-functional, matrixed, and global environment
- Excellent verbal and written English communication skills
- Excellent verbal and written Swedish
- Verbal and written skills in Chinese or Japanese is highly desired
- Negotiation skills
Aufgaben
- Lead cross-functional Virtual Plant Teams
- Act as the main point of contact for assigned CMOs and CLOs
- Drive strategic and operational management of CMOs and CLOs
- Conduct Business Reviews and Operational Meetings
- Manage supplier relationships and ensure compliance with supply agreements
- Oversee change orders and improvements for OTIF delivery
- Participate in sourcing and evaluating new contract manufacturers
- Develop supply and quality agreements
- Contribute to internal activities related to external manufacturing
- Manage change management and critical deviations
- Oversee CAPAs and related processes
- Issue, review, and approve relevant SOPs and manufacturing instructions
- Review applicable sections of APR and PQR
- Provide budget input for CMO and CLO-related costs
- Ensure adherence to budget for external manufacturing activities
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Schwedisch – verhandlungssicher
- Chinesisch – Grundkenntnisse
- Japanisch – Grundkenntnisse
Tools & Technologien
- MS Office
Benefits
Attraktive Vergütung
- Competitive compensation
Familienfreundlichkeit
- Emphasis on work/life balance
Lockere Unternehmenskultur
- Collaborative and team-oriented environment
Karriere- und Weiterentwicklung
- Opportunities for professional growth
Sonstige Vorteile
- Diversity and Inclusion
Sinnstiftende Arbeit
- Positive impact on ultra-rare disease patients
Über das Unternehmen
Sobi
Branche
Pharmaceuticals
Beschreibung
The company is a specialized biopharmaceutical company dedicated to rare diseases and committed to developing innovative therapies.
Noch nicht perfekt?
- Sobi
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Vollzeitmit HomeofficeSeniorBasel - BeOne Medicines I GmbH
Associate Director, External Supply Quality Europe(m/w/x)
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Data Manager Global Manufacturing & Supply(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Fresenius Medical Care
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Vollzeitmit HomeofficeSeniorBasel - Roche
Value Chain Product Lead within Cell and Gene Therapy(m/w/x)
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