Manager Analytical Development

K-Recruiting Life Sciences; Basel; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

K-Recruiting Life Sciences seeks a (Senior) Scientist Analytical Development to lead analytical development for small molecules, including peptides, from early development to commercialization. You will define control strategies, coordinate method development and validation, and ensure robust regulatory documentation.

Collaborating cross-functionally with process development, manufacturing, quality and regulatory, you will mentor junior scientists and contribute to digitalization and process

Qualifikationen

• MSc or PhD in chemistry, pharmacy, or related field with several years of industry experience.
• Strong background in analytical development for small molecules (ideally peptides) including regulatory filing support (e.g., IND/NDA) and impurity control strategies.
• Expertise in liquid chromatography (HPLC/UHPLC) with multiple detection techniques (e.g., UV, MS, fluorescence, CAD).
• Solid understanding of quality control and GMP across development phases.
• Fluency in English; additional languages are a plus.

Aufgaben

• Lead or contribute to analytical development activities across the full product lifecycle (early stage to market).
• Define and implement phase-appropriate control strategies for drug substances and drug products, including impurities.
• Coordinate analytical testing, including method development, optimization, validation, and data generation (e.g., stability, physico-chemical characterization).
• Collaborate cross-functionally with process development, manufacturing, quality, regulatory, and external partners.
• Ensure high-quality documentation for regulatory submissions; act as a technical lead and mentor to junior staff.
• Support innovation initiatives such as new technologies, digitalization, and process harmonization.

Kenntnisse

HPLC/UHPLC

Regulatory filing support

Analytical development

Cross-functional collaboration

GMP knowledge

English fluency

Ausbildung

MSc or PhD in chemistry, pharmacy, or related field

Tools

Statistical analysis

Digital tools

Jobbeschreibung

(Senior) Scientist Analytical Development (M/W/D)

This role is a (senior) scientific position within an analytical development function focused on synthetic (small molecule) pharmaceuticals. It sits in a global technical development environment, supporting products from early development through commercialization. The position involves contributing to advanced analytical strategies, cross-functional collaboration, and regulatory submissions.

Tasks:

• Lead / contribute to analytical development activities across the full product lifecycle (early stage to market).


• Define and implement phase-appropriate control strategies for drug substances and drug products, including impurities.


• Coordinate analytical testing, including method development, optimization, validation, and data generation (e.g., stability, physico-chemical characterization).


• Collaborate cross-functionally with process development, manufacturing, quality, regulatory, and external partners.


• Ensure high-quality documentation for regulatory submissions.


• (Act as a technical lead, mentoring junior scientists and technicians and serving as a key project contact.)


• Support innovation initiatives such as new technologies, digitalization, and process harmonization.

Qualifications:

• MSc or PhD in chemistry, pharmacy, or a related scientific field with several years of industry experience.


• Strong background in analytical development for small molecules (ideally peptides), including regulatory filing support (e.g., IND/NDA) and impurity control strategies.


• Expertise in liquid chromatography (HPLC/UHPLC) with multiple detection techniques (e.g., UV, MS, fluorescence, CAD).


• Solid understanding of quality control and GMP across development phases.


• Familiarity with statistical analysis and digital tools is advantageous.


• Strong communication and collaboration skills; able to work in cross-functional teams.


• Fluent in English; additional languages are a plus.


• Experience with complex modalities (e.g., peptides or oligonucleotides) is beneficial.