Novartis Pharma AG
Analytical Project Leader(m/w/x)
Vollzeitnur vor OrtSenior
Basel
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
IDIdorsia Pharmaceuticals Ltd
Analytical Project Manager(m/w/x)
Basel
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Developing and optimizing analytical methods for drug substances and products, including purity and genotoxic impurity determinations. Project management experience with CMOs/CROs and GMP knowledge required. Focus on small-molecule drugs for insomnia treatments.
Anforderungen
- College/university degree in chemistry, biochemistry, pharmacy, biology, or chemical engineering
- 10+ years BS, 7+ years MS, or 2+ years PhD experience in pharmaceutical industry
- Demonstrated previous success in project management
- Good knowledge of GMP regulations
- Good knowledge of regulatory requirements for Drug Substances and Drug Products development
- Broad knowledge in analytical chemistry
- Sound knowledge in synthetic chemistry
- Sound knowledge in drug substance processing
- Sound knowledge in formulation development
- Sound knowledge in pharmaceutical processing
- Experience in development of analytical tests for drug substances and products
- Experience in performance of analytical tests for drug substances and products
- Experience in international environments
- Experience in cross-cultural environments
- Excellent written communication skills
- Excellent verbal communication skills
- Excellent listening skills
- Excellent problem-solving ability
- Ability to measure and manage risk(s)
- Effective negotiation capabilities
- Effective influencing capabilities
- Reliability
- Conscientiousness
- Adaptability
- Ability to work independently
- Ability to work collaboratively in a matrixed environment
Aufgaben
- Develop state-of-the-art analytical methods for new drug substances and products
- Manage a portfolio of 2-4 projects based on their lifecycle
- Oversee analytical projects with CMOs and CROs
- Optimize and implement analytical methods for purity, stability, cleaning verification, excipients, content, and genotoxic impurity determinations
- Write and compile documents for method implementation
- Represent AD/QC in technical project and product team meetings
- Document all analytical activities according to Good Documentation Practices
- Review and approve analytical data and results
- Write, review, and approve analytical protocols and reports
- Establish and maintain analytical equipment according to GMP
- Draft and review CoAs, analytical results sheets, specifications, SOPs, GUIs, TPLs, and FRMs
- Organize GMP (re)qualification and validation of analytical equipment with external companies
- Design and execute projects or experiments independently
- Review scientific work in project-related activities
- Evaluate and develop novel analytical techniques and instrumentation
- Prepare source documents for IND, IMPD, and NDA/MA submissions
- Respond to agency questions and interact with Health Authorities
- Review CMC sections for IND/IMPD and NDA/MAA filings
- Participate in technology transfer between internal and external laboratories
Berufserfahrung
- 2 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
Tools & Technologien
- HPLC-UV
- HPLC-MS
- GC-MS
- NMR
- Spectroscopy
- wet chemistry
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Idorsia Pharmaceuticals Ltd erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- Lonza
Principal Scientist-Analytical Project Leader(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Analytical Molecular Characterization Team Lead and Mass Spectrometry Scientist(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Principal Analytical Steward - gMSAT Small Molecules(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Analytical Associate in Process Development Analytics for Synthetic Molecules(m/w/x)
Vollzeitnur vor OrtSeniorBasel
IDIdorsia Pharmaceuticals Ltd
Analytical Project Manager(m/w/x)
Basel
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Developing and optimizing analytical methods for drug substances and products, including purity and genotoxic impurity determinations. Project management experience with CMOs/CROs and GMP knowledge required. Focus on small-molecule drugs for insomnia treatments.
Anforderungen
- College/university degree in chemistry, biochemistry, pharmacy, biology, or chemical engineering
- 10+ years BS, 7+ years MS, or 2+ years PhD experience in pharmaceutical industry
- Demonstrated previous success in project management
- Good knowledge of GMP regulations
- Good knowledge of regulatory requirements for Drug Substances and Drug Products development
- Broad knowledge in analytical chemistry
- Sound knowledge in synthetic chemistry
- Sound knowledge in drug substance processing
- Sound knowledge in formulation development
- Sound knowledge in pharmaceutical processing
- Experience in development of analytical tests for drug substances and products
- Experience in performance of analytical tests for drug substances and products
- Experience in international environments
- Experience in cross-cultural environments
- Excellent written communication skills
- Excellent verbal communication skills
- Excellent listening skills
- Excellent problem-solving ability
- Ability to measure and manage risk(s)
- Effective negotiation capabilities
- Effective influencing capabilities
- Reliability
- Conscientiousness
- Adaptability
- Ability to work independently
- Ability to work collaboratively in a matrixed environment
Aufgaben
- Develop state-of-the-art analytical methods for new drug substances and products
- Manage a portfolio of 2-4 projects based on their lifecycle
- Oversee analytical projects with CMOs and CROs
- Optimize and implement analytical methods for purity, stability, cleaning verification, excipients, content, and genotoxic impurity determinations
- Write and compile documents for method implementation
- Represent AD/QC in technical project and product team meetings
- Document all analytical activities according to Good Documentation Practices
- Review and approve analytical data and results
- Write, review, and approve analytical protocols and reports
- Establish and maintain analytical equipment according to GMP
- Draft and review CoAs, analytical results sheets, specifications, SOPs, GUIs, TPLs, and FRMs
- Organize GMP (re)qualification and validation of analytical equipment with external companies
- Design and execute projects or experiments independently
- Review scientific work in project-related activities
- Evaluate and develop novel analytical techniques and instrumentation
- Prepare source documents for IND, IMPD, and NDA/MA submissions
- Respond to agency questions and interact with Health Authorities
- Review CMC sections for IND/IMPD and NDA/MAA filings
- Participate in technology transfer between internal and external laboratories
Berufserfahrung
- 2 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
Tools & Technologien
- HPLC-UV
- HPLC-MS
- GC-MS
- NMR
- Spectroscopy
- wet chemistry
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Idorsia Pharmaceuticals Ltd erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Idorsia Pharmaceuticals Ltd
Branche
Pharmaceuticals
Beschreibung
Idorsia is a biopharmaceutical company focused on discovering, developing, and commercializing transformative medicines.
Noch nicht perfekt?
- Novartis Pharma AG
Analytical Project Leader(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Lonza
Principal Scientist-Analytical Project Leader(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Analytical Molecular Characterization Team Lead and Mass Spectrometry Scientist(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Principal Analytical Steward - gMSAT Small Molecules(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Analytical Associate in Process Development Analytics for Synthetic Molecules(m/w/x)
Vollzeitnur vor OrtSeniorBasel