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Senior Expert Science & Technology (Process Analytical Sciences)(m/w/x)
Leading analytical strategy for Biologics DS/DP process development using Quality by Design principles. 3+ years (PhD) or 6+ years (MSc) in biopharma with Biologics DS/DP process development expertise required. Matrix leadership role.
Anforderungen
- University degree in pharmaceutical technology, biotechnology, biochemistry, chemistry, chemical engineering, or relevant natural science discipline
- At least 3 years (PhD) or 6 years (MSc) of working experience in the (bio)pharmaceutical industry
- Advanced knowledge in Analytical Development
- Expertise in Biologics DS and DP process development applying QbD principles
- Solid project management skills
- Excellent collaboration skills
- Proficiency in oral and written English; German is beneficial
- Strong proficiency in digital technologies
Aufgaben
- Lead analytical project activities as a matrix leader
- Establish physicochemical analytical strategies based on Quality by Design principles
- Interpret and contextualize analytical results
- Apply data and digital solutions to enhance efficiency
- Lead or support root cause investigations and issue resolution
- Monitor project progress and represent analytical aspects in meetings
- Oversee in-house and outsourced analytical work to meet timelines
- Author and review scientific reports and support regulatory submissions
- Act as an analytical expert during audits and inspections
- Manage multiple priorities and proactively communicate challenges
- Contribute to budget and resource planning while maintaining cost awareness
- Build strong relationships with internal teams and external partners
- Promote knowledge sharing and present results internally
- Contribute to publications, presentations, and patents
- Evaluate new analytical technologies and develop innovative methods
- Ensure alignment with scientific standards and contribute to digitalization efforts
- Respond to analytical queries during audits and regulatory reviews
- Ensure data integrity in CMC modules
Berufserfahrung
- 3 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Noch nicht perfekt?
- NovartisVollzeitnur vor OrtBerufserfahrenKundlab 65.605,54 / Jahr
- Novartis Pharmaceutical Manufacturing GmbH
Quality Team Leader QC(m/w/x)
Vollzeitnur vor OrtSeniorSchaftenauab 78.383,9 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Validation Lead(m/w/x)
Vollzeitnur vor OrtManagementKundlab 60.212,18 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Validation Lead(m/w/x)
Vollzeitnur vor OrtBerufserfahrenKundlab 60.212,18 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Global Head QA Operations Aseptics(m/w/x)
Vollzeitnur vor OrtSeniorSchaftenau
Senior Expert Science & Technology (Process Analytical Sciences)(m/w/x)
Leading analytical strategy for Biologics DS/DP process development using Quality by Design principles. 3+ years (PhD) or 6+ years (MSc) in biopharma with Biologics DS/DP process development expertise required. Matrix leadership role.
Anforderungen
- University degree in pharmaceutical technology, biotechnology, biochemistry, chemistry, chemical engineering, or relevant natural science discipline
- At least 3 years (PhD) or 6 years (MSc) of working experience in the (bio)pharmaceutical industry
- Advanced knowledge in Analytical Development
- Expertise in Biologics DS and DP process development applying QbD principles
- Solid project management skills
- Excellent collaboration skills
- Proficiency in oral and written English; German is beneficial
- Strong proficiency in digital technologies
Aufgaben
- Lead analytical project activities as a matrix leader
- Establish physicochemical analytical strategies based on Quality by Design principles
- Interpret and contextualize analytical results
- Apply data and digital solutions to enhance efficiency
- Lead or support root cause investigations and issue resolution
- Monitor project progress and represent analytical aspects in meetings
- Oversee in-house and outsourced analytical work to meet timelines
- Author and review scientific reports and support regulatory submissions
- Act as an analytical expert during audits and inspections
- Manage multiple priorities and proactively communicate challenges
- Contribute to budget and resource planning while maintaining cost awareness
- Build strong relationships with internal teams and external partners
- Promote knowledge sharing and present results internally
- Contribute to publications, presentations, and patents
- Evaluate new analytical technologies and develop innovative methods
- Ensure alignment with scientific standards and contribute to digitalization efforts
- Respond to analytical queries during audits and regulatory reviews
- Ensure data integrity in CMC modules
Berufserfahrung
- 3 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Über das Unternehmen
Novartis Pharmaceutical Manufacturing GmbH
Branche
Pharmaceuticals
Beschreibung
The company aims to reimagine medicine to improve and extend people's lives.
Noch nicht perfekt?
- Novartis
Mass Spectrometry Expert - Analytical Characterization of Biopharmaceuticals(m/w/x)
Vollzeitnur vor OrtBerufserfahrenKundlab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Quality Team Leader QC(m/w/x)
Vollzeitnur vor OrtSeniorSchaftenauab 78.383,9 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Validation Lead(m/w/x)
Vollzeitnur vor OrtManagementKundlab 60.212,18 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Validation Lead(m/w/x)
Vollzeitnur vor OrtBerufserfahrenKundlab 60.212,18 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Global Head QA Operations Aseptics(m/w/x)
Vollzeitnur vor OrtSeniorSchaftenau