Dein persönlicher KI-Karriere-Agent
(Senior) Analytical Lead, Process Science (m/w/x)
Analytical method development and validation for rare disease therapies. 10+ years analytical development experience required. Home office, bonus, and flexible hours.
Deine Match-Analyse
Warum dieser Job zu dir passt
Mögliche Lücken
Tipps für deine Bewerbung
Anforderungen
- Higher degree (PhD or Master’s) in technical/scientific discipline
- 10+ years professional experience in analytical development/validation
- Deep expertise in at least one CMC area
- Strong working knowledge of broader CMC environment
- In-depth knowledge of analytical instruments/techniques
- Experience in chromatography and mass spectrometry
- Experience in stability studies and impurity profiling
- Familiarity with EMA, FDA, ICH, WHO, global regulatory requirements
- Experience with regulatory submissions or health authorities (advantageous)
- Experience with investigations, OOS, deviations, CAPAs (beneficial)
- Ability to lead without hierarchical authority
- Work effectively in international, cross-functional matrix teams
- Strong strategic thinking capabilities
- Strong execution capabilities
- Strong project management capabilities
- Strong analytical capabilities
- Strong problem-solving capabilities
- Customer-oriented mindset
- Collaborative mindset
- Ability to build strong relationships with stakeholders
- Excellent verbal communication skills in English
- Excellent presentation skills in English
- Excellent written communication skills in English
- Basic German skills (beneficial)
Aufgaben
- Provide scientific and technical leadership for analytical programs
- Shape robust analytical strategies
- Support product development and regulatory submissions
- Ensure reliable clinical and commercial manufacturing
- Develop, validate, and implement analytical methods
- Lead analytical development and testing programs
- Review and approve analytical documentation
- Interpret development and stability data
- Support the development of specifications
- Lead impurity assessments
- Provide technical guidance for analytical issues
- Collaborate with stakeholders to support product development
- Represent Process Science in Technical Development teams
- Communicate risks, critical topics, and solutions
- Support regulatory submissions with analytical data
- Provide technical input for due diligence
- Plan and monitor budgets for assigned activities
- Identify opportunities for cost and risk reduction
- Drive continuous improvement in analytical technology and processes
- Promote knowledge sharing and scientific learning
- Mentor Process Science Analytical Leads
- Support team member onboarding, training, and development
Berufserfahrung
Ausbildung
Sprachen
Tools & Technologien
Benefits
- Competitive salary package
- Bonus
- Homeoffice
- Flexible working hours
- Employee mobile phone
- Laptop
- Initial and continuing education
- Canteen
- Good transport connection
- Parking spot
- Employee events
- Meal allowance
- Company doctor
- Health measures
- Employee discount
- Company car
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens AOP Health 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.
Zur Originalanzeige bei AOP HealthÜber das Unternehmen
AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care.
Nejo bewertet ihn, und bringt ihn danach gemeinsam mit dir in Bestform.
Noch nicht perfekt?
- University of ViennaUniversity Assistant Postdoctoral (m/w/x)Vollzeit/TeilzeitBefristeter Vertragmit HomeofficeSeniorWienab 70.190,2 / Jahr
- ICON Clinical Research Austria GmbH(Senior) Clinical Research Associate (m/w/x)VollzeitRemoteSeniorWien
- Boehringer IngelheimPrincipal Scientist Pathology (m/w/x)Vollzeitmit HomeofficeJuniorWienab 90.900 / Jahr
- Efinio IT & ENGINEERINGSenior Verfahrenstechniker - Biopharma (m/w/x)Vollzeitmit HomeofficeSeniorWienab 90.000 / Jahr
- AOP HealthAI Transformation Lead (m/w/x)Vollzeitmit HomeofficeSeniorWienab 54.642 / Jahr