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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.
Requirements
- 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
Tasks
- 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
Work Experience
- 3 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
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- Novartis Pharmaceutical Manufacturing GmbHVollzeit/Teilzeitnur vor OrtBerufserfahrenSchaftenauab 60.600 / Jahr
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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.
Requirements
- 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
Tasks
- 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
Work Experience
- 3 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Novartis Pharmaceutical Manufacturing GmbH
Industry
Pharmaceuticals
Description
The company aims to reimagine medicine to improve and extend people's lives.
Noch nicht perfekt?
- Novartis Pharmaceutical Manufacturing GmbH
AS&T Expert(m/w/x)
Vollzeit/Teilzeitnur vor OrtBerufserfahrenSchaftenauab 60.600 / Jahr - Novartis
Mass Spectrometry Expert - Analytical Characterization of Biopharmaceuticals(m/w/x)
Vollzeitnur vor OrtBerufserfahrenKundlab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
AS&T Expert(m/w/x)
Vollzeit/Teilzeitnur vor OrtBerufserfahrenSchaftenauab 60.600 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Drug Product Project Leader – Associate Director Science & Technology(m/w/x)
Vollzeit/Teilzeitnur vor OrtSeniorSchaftenauab 78.383,9 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Senior Quality Assurance Operations Specialist(m/w/x)
Vollzeitnur vor OrtSeniorKundl