Analytical Sciences Consultant in Biotech/Pharma (GMP): APIs and Nanomedicines (drug substance/products)
Aktualisiert am 04.12.2025
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 04.12.2025
Verfügbar zu: 75%
davon vor Ort: 20%
Analytical Sciences
QC
Good Manufacturing Practice
Nano
Nanomedicines
small molecules
API
HPLC
GC
NMR
Stability
Quality
Control
Biotechnologie
Laboratory Quality Control
Laborplanung
Methodenentwicklung
Method development
Validierung
DLS
AF4-MALS
FTIR
CMC
German
English
Dutch
Mandarin
Spanish
? French

Einsatzorte

Einsatzorte

Ansbach, Mittelfranken (+200km) Nuremberg (+50km) Würzburg (+50km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

8 months
2025-04 - now

Analytical Sciences

Consultant
Consultant
  • Expert in Analytical Sciences, specialized in Nanomedicines
  • Providing strategic CMC and GMP guidance
on request
Bad Windsheim, Germany
7 months
2025-04 - 2025-10

Method development for Oligonucleotides under GMP with HPLC-MS

Consultant
Consultant

  • Supported a Polish pharmaceutical company on a time-critical oligonucleotide program.
  • The primary focus was on developing an  HPLC-MS method for quantifying P=O impurities in various batches and as a quality control.

Methodenentwicklung
Remote
2 years 2 months
2023-03 - 2025-04

Analytical Sciences Nanomedicines

Director
Director

  • Lead and develop the analytical department of 20+ scientists
  • Define department strategy in alignment with company goals
  • Recruitment of new and performance evaluation of current employees
  • Foster a culture of efficiency, quality, and continuous improvement
  • Ensure staff training, development, and retention
  • Regulatory and compliance oversight (according to GMP, ICH, ISO)
  • Oversee the development and validation of analytical methods
  • Involved in business development and cost calculations
  • Spearheaded the expansion of the AS labs into a newly built facility

Ardena
Oss, The Netherlands
2 years 7 months
2021-01 - 2023-07

Monitoring of budget

Group Lead
Group Lead
  • Same as Analytical Lead plus personnel and financial responsibilities.
  • Monitoring of budget and preparation of quotes for (future) customers.
  • Implement advanced analytical technologies to meet client needs
  • Improving work procedures to enhance quality, efficiency and outputof people and other resources.
Ardena
1 year 8 months
2019-05 - 2020-12

Coordination and planning of resources

Analytical Lead
Analytical Lead
  • Preparation, review and approval of GMP-relevant documents suchas specifications, CoA´s, analytical methods, validations and stabilityprotocols and reports in accordance with ICH guidelines.
  • Coordination and planning of resources to meet customers timelines.
  • Work closely with PR&D, Quality, and Manufacturing teams
Ardena
3 years 1 month
2016-02 - 2019-02

Synthesis and Characterization

Senior Research Associate
Senior Research Associate

Synthesis and Characterization of Well-defined Unimolecular Core-Shell Polypept(o)ide Nanoparticles

Sun Yat-sen University
Guangzhou, China

Aus- und Weiterbildung

Aus- und Weiterbildung

3 years 4 months
2011-04 - 2014-07

Chemistry

PhD, University of Mainz
PhD
University of Mainz
Title on request
7 years 6 months
2003-10 - 2011-03

Biomedical Chemistry

Diploma, University of Mainz
Diploma
University of Mainz

  • Organic Chemistry
  • Analytical Chemistry
  • Biopolymer Chemistry
  • Biochemistry
  • Diploma Thesis: on request

9 years 9 months
1992-10 - 2002-06

School Education

Abitur, G.W.-Steller Gymnasium, Bad Windsheim, Germany
Abitur
G.W.-Steller Gymnasium, Bad Windsheim, Germany

Position

Position


Kompetenzen

Kompetenzen

Top-Skills

Analytical Sciences QC Good Manufacturing Practice Nano Nanomedicines small molecules API HPLC GC NMR Stability Quality Control Biotechnologie Laboratory Quality Control Laborplanung Methodenentwicklung Method development Validierung DLS AF4-MALS FTIR CMC

Produkte / Standards / Erfahrungen / Methoden

Profile

Enthusiastic project and people manager with 6+ years experience in the pharmaceutical industry. Expert in a wide range of analytical characterization techniques, applicable from classic API analysis to highly advanced formulations. Proven track record of leading highperforming teams of highly educated people with a strong focus on results, efficiency and quality. Committed to fostering a working culture of continuous improvement, employee development and long-term retention.


Analytical Skills

  • HPLC/UPLC(UV/FLD/CAD/MS)
  • GPC/SEC
  • NMR (2D/3D)
  • DLS/SLS
  • GC (HS/FID)
  • MALDI-ToF-MS
  • Electrophoresis(CE/AG/SDS-PAGE)
  • AF4-MALS
  • AAS
  • TOC/TGA/DSC

Labor / Qualitätskontrolle

QC
Experte
Method development
Experte
Labor management
Experte
Analytical Sciences
Experte
HPLC
Experte
GC
Experte
NMR
Experte
Light Scattering
Experte
CMC
Experte
API
Experte

Managementerfahrung in Unternehmen

Leadership
Experte
People development
Experte

Branchen

Branchen

  • Pharmaceutical Industry

Einsatzorte

Einsatzorte

Ansbach, Mittelfranken (+200km) Nuremberg (+50km) Würzburg (+50km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

8 months
2025-04 - now

Analytical Sciences

Consultant
Consultant
  • Expert in Analytical Sciences, specialized in Nanomedicines
  • Providing strategic CMC and GMP guidance
on request
Bad Windsheim, Germany
7 months
2025-04 - 2025-10

Method development for Oligonucleotides under GMP with HPLC-MS

Consultant
Consultant

  • Supported a Polish pharmaceutical company on a time-critical oligonucleotide program.
  • The primary focus was on developing an  HPLC-MS method for quantifying P=O impurities in various batches and as a quality control.

Methodenentwicklung
Remote
2 years 2 months
2023-03 - 2025-04

Analytical Sciences Nanomedicines

Director
Director

  • Lead and develop the analytical department of 20+ scientists
  • Define department strategy in alignment with company goals
  • Recruitment of new and performance evaluation of current employees
  • Foster a culture of efficiency, quality, and continuous improvement
  • Ensure staff training, development, and retention
  • Regulatory and compliance oversight (according to GMP, ICH, ISO)
  • Oversee the development and validation of analytical methods
  • Involved in business development and cost calculations
  • Spearheaded the expansion of the AS labs into a newly built facility

Ardena
Oss, The Netherlands
2 years 7 months
2021-01 - 2023-07

Monitoring of budget

Group Lead
Group Lead
  • Same as Analytical Lead plus personnel and financial responsibilities.
  • Monitoring of budget and preparation of quotes for (future) customers.
  • Implement advanced analytical technologies to meet client needs
  • Improving work procedures to enhance quality, efficiency and outputof people and other resources.
Ardena
1 year 8 months
2019-05 - 2020-12

Coordination and planning of resources

Analytical Lead
Analytical Lead
  • Preparation, review and approval of GMP-relevant documents suchas specifications, CoA´s, analytical methods, validations and stabilityprotocols and reports in accordance with ICH guidelines.
  • Coordination and planning of resources to meet customers timelines.
  • Work closely with PR&D, Quality, and Manufacturing teams
Ardena
3 years 1 month
2016-02 - 2019-02

Synthesis and Characterization

Senior Research Associate
Senior Research Associate

Synthesis and Characterization of Well-defined Unimolecular Core-Shell Polypept(o)ide Nanoparticles

Sun Yat-sen University
Guangzhou, China

Aus- und Weiterbildung

Aus- und Weiterbildung

3 years 4 months
2011-04 - 2014-07

Chemistry

PhD, University of Mainz
PhD
University of Mainz
Title on request
7 years 6 months
2003-10 - 2011-03

Biomedical Chemistry

Diploma, University of Mainz
Diploma
University of Mainz

  • Organic Chemistry
  • Analytical Chemistry
  • Biopolymer Chemistry
  • Biochemistry
  • Diploma Thesis: on request

9 years 9 months
1992-10 - 2002-06

School Education

Abitur, G.W.-Steller Gymnasium, Bad Windsheim, Germany
Abitur
G.W.-Steller Gymnasium, Bad Windsheim, Germany

Position

Position


Kompetenzen

Kompetenzen

Top-Skills

Analytical Sciences QC Good Manufacturing Practice Nano Nanomedicines small molecules API HPLC GC NMR Stability Quality Control Biotechnologie Laboratory Quality Control Laborplanung Methodenentwicklung Method development Validierung DLS AF4-MALS FTIR CMC

Produkte / Standards / Erfahrungen / Methoden

Profile

Enthusiastic project and people manager with 6+ years experience in the pharmaceutical industry. Expert in a wide range of analytical characterization techniques, applicable from classic API analysis to highly advanced formulations. Proven track record of leading highperforming teams of highly educated people with a strong focus on results, efficiency and quality. Committed to fostering a working culture of continuous improvement, employee development and long-term retention.


Analytical Skills

  • HPLC/UPLC(UV/FLD/CAD/MS)
  • GPC/SEC
  • NMR (2D/3D)
  • DLS/SLS
  • GC (HS/FID)
  • MALDI-ToF-MS
  • Electrophoresis(CE/AG/SDS-PAGE)
  • AF4-MALS
  • AAS
  • TOC/TGA/DSC

Labor / Qualitätskontrolle

QC
Experte
Method development
Experte
Labor management
Experte
Analytical Sciences
Experte
HPLC
Experte
GC
Experte
NMR
Experte
Light Scattering
Experte
CMC
Experte
API
Experte

Managementerfahrung in Unternehmen

Leadership
Experte
People development
Experte

Branchen

Branchen

  • Pharmaceutical Industry

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Im Bereich Arbeitnehmerüberlassung / Personalvermittlung

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