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Product Expert / Analytical Process Manager(m/w/x)
At a biopharmaceutical CDMO, coordinating analytical science for customer projects, managing external biophysical activities and CQA evaluations. PhD or several years of biopharmaceutical industrial experience, with QbD development knowledge required. 30 vacation days, flexible working hours, remote work options.
Anforderungen
- Degree in Life Sciences (pharmacy, immunology, chemistry, biochemistry) preferably with PhD or several years of industrial experience in biopharmaceutical fields
- Profound knowledge regarding the assessment of product quality and cQAs in biopharmaceutical products
- Sound knowledge on chromatographic and/or electrophoretic analytical methods and/or immunoassays
- Very good knowledge in immunology and/or medical/pharmaceutical knowledge with experience in pharmacokinetics/-dynamics of biopharmaceuticals
- Several years of experience in QbD-based biopharmaceutical development
- Proficiency in MS-Office programs and fluency in English
- Collaborative communication skills and confident presentation in front of multidisciplinary teams and external customers
- Scientific curiosity, analytical thinking, and efficient work in dynamic multifaceted tasks
- Team player with high initiative and organizational skills
Aufgaben
- Represent Analytical Science in customer project teams
- Coordinate Analytical Science activities for assigned customer projects
- Manage external biophysical analytical activities
- Contribute to Critical Quality Attributes evaluations
- Coordinate product characterization studies
- Implement the Quality-by-Design strategy in project teams
- Advise teams and clients on cQAs and QbD development
- Ensure adherence to project timelines and milestones
- Contribute to product quality risk assessments
- Prepare and write reports and presentations in English
- Present results and strategic topics in meetings and conferences
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS-Office
Benefits
Flexibles Arbeiten
- Flexible working hours
- Flexitime account
- Options for remote work
Mehr Urlaubstage
- 30 vacation days
- Special leave days
Attraktive Vergütung
- Attractive salary
Boni & Prämien
- 13th-month salary
Weiterbildungsangebote
- Personalized training programs
- Comprehensive onboarding program
Gratis oder Vergünstigte Mahlzeiten
- Cafeteria with vegetarian/vegan options
Gesundheits- & Fitnessangebote
- Corporate health management
- Company doctor
Team Events & Ausflüge
- Team and company events
Mitarbeiterrabatte
- Variety of employee discounts
Öffi Tickets
- Discounts on job ticket
Sonstige Zulagen
- Financial relocation support
Parkplatz & Pendelvorteile
- Free parking
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- Rentschler Biopharma SEVollzeitmit HomeofficeSeniorLaupheim
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Product Expert / Analytical Process Manager(m/w/x)
At a biopharmaceutical CDMO, coordinating analytical science for customer projects, managing external biophysical activities and CQA evaluations. PhD or several years of biopharmaceutical industrial experience, with QbD development knowledge required. 30 vacation days, flexible working hours, remote work options.
Anforderungen
- Degree in Life Sciences (pharmacy, immunology, chemistry, biochemistry) preferably with PhD or several years of industrial experience in biopharmaceutical fields
- Profound knowledge regarding the assessment of product quality and cQAs in biopharmaceutical products
- Sound knowledge on chromatographic and/or electrophoretic analytical methods and/or immunoassays
- Very good knowledge in immunology and/or medical/pharmaceutical knowledge with experience in pharmacokinetics/-dynamics of biopharmaceuticals
- Several years of experience in QbD-based biopharmaceutical development
- Proficiency in MS-Office programs and fluency in English
- Collaborative communication skills and confident presentation in front of multidisciplinary teams and external customers
- Scientific curiosity, analytical thinking, and efficient work in dynamic multifaceted tasks
- Team player with high initiative and organizational skills
Aufgaben
- Represent Analytical Science in customer project teams
- Coordinate Analytical Science activities for assigned customer projects
- Manage external biophysical analytical activities
- Contribute to Critical Quality Attributes evaluations
- Coordinate product characterization studies
- Implement the Quality-by-Design strategy in project teams
- Advise teams and clients on cQAs and QbD development
- Ensure adherence to project timelines and milestones
- Contribute to product quality risk assessments
- Prepare and write reports and presentations in English
- Present results and strategic topics in meetings and conferences
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS-Office
Benefits
Flexibles Arbeiten
- Flexible working hours
- Flexitime account
- Options for remote work
Mehr Urlaubstage
- 30 vacation days
- Special leave days
Attraktive Vergütung
- Attractive salary
Boni & Prämien
- 13th-month salary
Weiterbildungsangebote
- Personalized training programs
- Comprehensive onboarding program
Gratis oder Vergünstigte Mahlzeiten
- Cafeteria with vegetarian/vegan options
Gesundheits- & Fitnessangebote
- Corporate health management
- Company doctor
Team Events & Ausflüge
- Team and company events
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.
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Prozessingenieur / Scientist Downstream Entwicklung(m/w/x)
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Pharmazeutischer Operator USP Produktion(m/w/x)
Vollzeitmit HomeofficeKeine AngabeLaupheim