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Process Manager - MSAT - DSP(m/w/x)
Designing scalable downstream processes for biopharmaceuticals in a CDMO, defining control strategies, with direct customer communication. Multiple years of experience in biopharmaceutical downstream processing with scalable technologies required. Direct customer interaction, cross-departmental collaboration.
Anforderungen
- University degree in biotechnology, pharmaceutical engineering, bioprocess engineering, chemical engineering, or comparable scientific/technical field
- Multiple years of experience in downstream processing using scalable technologies in biopharmaceutical manufacturing
- Strong and motivating communication skills
- Team spirit
- Flexibility
- High level of initiative
- Personal responsibility
- Excellent organizational skills
- Entrepreneurial mindset
- Economic and analytical thinking
- Fluency in English
- Relevant experience with commercial products CPV will be considered an asset
- Experience in process performance qualification (PPQ) is desirable
- Know-how in statistical concepts and software (e.g. JMP) is a plus
Aufgaben
- Design robust and scalable downstream processes for biopharmaceuticals
- Define control strategies for commercial manufacturing
- Set up and perform continued process verification (CPV)
- Communicate directly with customers in meetings and conference calls
- Collaborate with colleagues from associated departments
- Troubleshoot and optimize processes at manufacturing scale
- Participate in deviations, out-of-specifications, and change management
- Review and own process descriptions, risk assessments, protocols, and reports
- Ensure compliance with international technological and regulatory standards
- Review relevant chapters of CMC dossiers (IND/IMPD and BLA/MAA)
- Participate in client audits and authority inspections
- Engage in process optimization and innovation projects
- Continuously strive for improvement and optimization in all work areas
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- JMP
Benefits
Attraktive Vergütung
- Attractive salary
Boni & Prämien
- 13th-month salary
Lockere Unternehmenskultur
- Collegial work environment
Weiterbildungsangebote
- Personalized training programs
- Comprehensive onboarding program
Flexibles Arbeiten
- Flexible working hours
- Flexitime account
- Options for remote work
Mehr Urlaubstage
- 30 vacation days
- Special leave days
Gratis oder Vergünstigte Mahlzeiten
- Cafeteria with vegetarian/vegan options
Gesundheits- & Fitnessangebote
- Corporate health management
- Company doctor
Betriebliche Altersvorsorge
- Company pension plan
Team Events & Ausflüge
- Team and company events
Firmenfahrrad
- Leasing options for (e-)bikes
Kinderbetreuung
- In-house daycare center
Sicherer Arbeitsplatz
- Permanent employment contract
Mitarbeiterrabatte
- Variety of employee discounts
Öffi Tickets
- Discounts on job ticket
Sonstige Zulagen
- Financial relocation support
Parkplatz & Pendelvorteile
- Free parking
Noch nicht perfekt?
- Rentschler Biopharma SEVollzeitmit HomeofficeBerufserfahrenLaupheim
- Rentschler Biopharma SE
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Process Manager - MSAT - DSP(m/w/x)
Designing scalable downstream processes for biopharmaceuticals in a CDMO, defining control strategies, with direct customer communication. Multiple years of experience in biopharmaceutical downstream processing with scalable technologies required. Direct customer interaction, cross-departmental collaboration.
Anforderungen
- University degree in biotechnology, pharmaceutical engineering, bioprocess engineering, chemical engineering, or comparable scientific/technical field
- Multiple years of experience in downstream processing using scalable technologies in biopharmaceutical manufacturing
- Strong and motivating communication skills
- Team spirit
- Flexibility
- High level of initiative
- Personal responsibility
- Excellent organizational skills
- Entrepreneurial mindset
- Economic and analytical thinking
- Fluency in English
- Relevant experience with commercial products CPV will be considered an asset
- Experience in process performance qualification (PPQ) is desirable
- Know-how in statistical concepts and software (e.g. JMP) is a plus
Aufgaben
- Design robust and scalable downstream processes for biopharmaceuticals
- Define control strategies for commercial manufacturing
- Set up and perform continued process verification (CPV)
- Communicate directly with customers in meetings and conference calls
- Collaborate with colleagues from associated departments
- Troubleshoot and optimize processes at manufacturing scale
- Participate in deviations, out-of-specifications, and change management
- Review and own process descriptions, risk assessments, protocols, and reports
- Ensure compliance with international technological and regulatory standards
- Review relevant chapters of CMC dossiers (IND/IMPD and BLA/MAA)
- Participate in client audits and authority inspections
- Engage in process optimization and innovation projects
- Continuously strive for improvement and optimization in all work areas
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- JMP
Benefits
Attraktive Vergütung
- Attractive salary
Boni & Prämien
- 13th-month salary
Lockere Unternehmenskultur
- Collegial work environment
Weiterbildungsangebote
- Personalized training programs
- Comprehensive onboarding program
Flexibles Arbeiten
- Flexible working hours
- Flexitime account
- Options for remote work
Mehr Urlaubstage
- 30 vacation days
- Special leave days
Gratis oder Vergünstigte Mahlzeiten
- Cafeteria with vegetarian/vegan options
Gesundheits- & Fitnessangebote
- Corporate health management
- Company doctor
Betriebliche Altersvorsorge
- Company pension plan
Team Events & Ausflüge
- Team and company events
Firmenfahrrad
- Leasing options for (e-)bikes
Kinderbetreuung
- In-house daycare center
Sicherer Arbeitsplatz
- Permanent employment contract
Mitarbeiterrabatte
- Variety of employee discounts
Öffi Tickets
- Discounts on job ticket
Sonstige Zulagen
- Financial relocation support
Parkplatz & Pendelvorteile
- Free parking
Über das Unternehmen
Rentschler Biopharma SE
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein führender Auftragsentwicklungs- und Herstellungsbetrieb (CDMO), der sich auf biopharmazeutische Lösungen spezialisiert hat.
Noch nicht perfekt?
- Rentschler Biopharma SE
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