Die KI-Suchmaschine für Jobs
Analytical Method Expert (Associate Director AS&T Lifecycle Management)(m/w/x)
Beschreibung
In this role, you will play a crucial part in product development and regulatory submissions for RNA and protein-based therapeutics. You will ensure that analytical methods meet GMP standards while collaborating with cross-functional teams and external partners.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
Anforderungen
- •Advanced university degree in a scientific discipline
- •Industry experience in CMC development/commercial
- •Background in organic chemistry and/or Biologics product development
- •In-depth knowledge of analytical techniques with hands-on experience in assay development and validation
- •Experience with HPLC, GC, mass spectrometry, NMR, and IR techniques
- •Experience with chromatographic, spectroscopic, electrophoretic, immunoassay and molecular biology techniques
- •Experience with cell-based and immunoassays, molecular biology and physicochemical techniques
- •Expertise in analytical control strategies and method validation concepts
- •Experience in intercultural, cross-functional teams
- •Structured way of working and ability to break down complex challenges
- •Highly motivated and willingness to work in a fast-paced environment
Ausbildung
Berufserfahrung
5 Jahre
Aufgaben
- •Provide technical analytical expertise for late-stage and commercial projects
- •Ensure compliance with GMP standards and industry guidelines
- •Develop method validation and transfer strategies
- •Manage method lifecycle activities, including reagent exchange and laboratory investigations
- •Engage in strategic and technical discussions with CMC team members and external partners
- •Evaluate and review technical and regulatory submission documents
- •Act as the analytical subject matter expert for regulatory filings
- •Respond to inquiries from health authorities regarding regulatory submissions
Tools & Technologien
Sprachen
Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- •Flexible hours
Mehr Urlaubstage
- •Vacation account
Weiterbildungsangebote
- •Digital learning
- •Apprenticeships
- •LinkedIn learning
Mentoring & Coaching
- •Performance & talent development
- •Leadership development
- •Support for your full potential
Startup-Atmosphäre
- •Your voice at the table
Lockere Unternehmenskultur
- •Culture on an equal footing
Sinnstiftende Arbeit
- •Opportunities to shape & impact
Firmenfahrrad
- •Company bike
Öffi Tickets
- •Job ticket
- •Deutschlandticket
Betriebliche Altersvorsorge
- •Employer-funded pension
Kinderbetreuung
- •Childcare
- BioNTech SEVollzeitnur vor OrtSeniorMainz
- Boehringer Ingelheim
Head of Analytical Development Pharmaceutical(m/w/x)
Vollzeitnur vor OrtManagementIngelheim am Rhein - BioNTech SE
Senior Director Protein Modality Lead(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Director CMC Materials Lead(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Associate Director Procurement CDMO(m/w/x)
Vollzeitnur vor OrtSeniorMainz
Analytical Method Expert (Associate Director AS&T Lifecycle Management)(m/w/x)
Die KI-Suchmaschine für Jobs
Beschreibung
In this role, you will play a crucial part in product development and regulatory submissions for RNA and protein-based therapeutics. You will ensure that analytical methods meet GMP standards while collaborating with cross-functional teams and external partners.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
Anforderungen
- •Advanced university degree in a scientific discipline
- •Industry experience in CMC development/commercial
- •Background in organic chemistry and/or Biologics product development
- •In-depth knowledge of analytical techniques with hands-on experience in assay development and validation
- •Experience with HPLC, GC, mass spectrometry, NMR, and IR techniques
- •Experience with chromatographic, spectroscopic, electrophoretic, immunoassay and molecular biology techniques
- •Experience with cell-based and immunoassays, molecular biology and physicochemical techniques
- •Expertise in analytical control strategies and method validation concepts
- •Experience in intercultural, cross-functional teams
- •Structured way of working and ability to break down complex challenges
- •Highly motivated and willingness to work in a fast-paced environment
Ausbildung
Berufserfahrung
5 Jahre
Aufgaben
- •Provide technical analytical expertise for late-stage and commercial projects
- •Ensure compliance with GMP standards and industry guidelines
- •Develop method validation and transfer strategies
- •Manage method lifecycle activities, including reagent exchange and laboratory investigations
- •Engage in strategic and technical discussions with CMC team members and external partners
- •Evaluate and review technical and regulatory submission documents
- •Act as the analytical subject matter expert for regulatory filings
- •Respond to inquiries from health authorities regarding regulatory submissions
Tools & Technologien
Sprachen
Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- •Flexible hours
Mehr Urlaubstage
- •Vacation account
Weiterbildungsangebote
- •Digital learning
- •Apprenticeships
- •LinkedIn learning
Mentoring & Coaching
- •Performance & talent development
- •Leadership development
- •Support for your full potential
Startup-Atmosphäre
- •Your voice at the table
Lockere Unternehmenskultur
- •Culture on an equal footing
Sinnstiftende Arbeit
- •Opportunities to shape & impact
Firmenfahrrad
- •Company bike
Öffi Tickets
- •Job ticket
- •Deutschlandticket
Betriebliche Altersvorsorge
- •Employer-funded pension
Kinderbetreuung
- •Childcare
Über das Unternehmen
BioNTech SE
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
- BioNTech SE
Director Manufacturing Sciences & Technology(m/w/x)
Vollzeitnur vor OrtSeniorMainz - Boehringer Ingelheim
Head of Analytical Development Pharmaceutical(m/w/x)
Vollzeitnur vor OrtManagementIngelheim am Rhein - BioNTech SE
Senior Director Protein Modality Lead(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Director CMC Materials Lead(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Associate Director Procurement CDMO(m/w/x)
Vollzeitnur vor OrtSeniorMainz