Senior Scientist Analytical Development

K-Recruiting GmbH; Lavamünd; Vor Ort; EUR 128.000 - 159.000; Vollzeit

Zusammenfassung

K-Recruiting GmbH seeks a Senior Scientist Analytical Development in Basel to lead analytical development from early stage to market, coordinating method development, validation, and impurity strategies. The role requires collaboration across process development, manufacturing, quality, and regulatory teams.

You will mentor junior staff and contribute to regulatory submissions, while supporting innovation efforts in digitalization and process harmonization.

Qualifikationen

• Advanced degree in chemistry/pharmacy with several years of industry experience.
• Strong background in analytical development for small molecules and regulatory filing support.
• Expertise in LC/HPLC/UHPLC with multiple detection techniques.
• Solid GMP and quality control understanding across development.
• Familiarity with statistical analysis and digital tools is advantageous.
• Excellent communication and cross-functional collaboration skills.
• Fluent in English; other languages a plus.

Aufgaben

• Lead analytical development activities across the full product lifecycle (early to market).
• Define and implement phase-appropriate control strategies for drug substances/products, including impurities.
• Coordinate analytical testing: method development, optimization, validation and data generation.
• Collaborate with process development, manufacturing, QA, regulatory and external partners.
• Ensure high-quality documentation for regulatory submissions.
• Mentor junior scientists and act as a key project contact.
• Support innovation initiatives like new technologies, digitalization, and process harmonization.

Kenntnisse

Analytical development

Small molecules

Regulatory filing support

Impurity control

LC/HPLC/UHPLC

Detection techniques (UV, MS, FLU, CAD

Quality control & GMP

Statistics & data analysis

Digital tools

Cross-functional collaboration

English fluency

Complex modalities experience

Ausbildung

MSc or PhD in chemistry/pharmacy/related field

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 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, 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.

Conditions:

• Start: ASAP
• Duration: 6 months
• Workload: Full-time

Location: Onsite Basel