Senior Analytical Manager BioSpectroscopy

Solvias; Kaiseraugst; Vor Ort; CHF 140.000 - 200.000; Vollzeit

Zusammenfassung

Solvias is seeking a senior analytical lab leader to head a high-performing team in BioSpectroscopy, driving GMP-regulated CMC testing and advanced characterization. You will shape operations, mentor scientists and lab technicians, manage budget and capacity, and collaborate with senior leadership and customers to ensure compliance with GMP/ISO standards while pursuing continuous improvement.

The role requires proven leadership in analytical testing, regulatory compliance, and strong

Qualifikationen

• Over 5 years in biopharmaceutical drug development environment with GMP testing.
• Strong leadership experience in analytical labs.
• Experience in regulatory compliance and analytical method development.
• Excellent communication and customer engagement skills.

Aufgaben

• Lead an analytical lab operations team focusing on BioSpectroscopy in GMP-regulated drug development.
• Define priorities across lab sub-areas and ensure workload balance.
• Oversee capacity planning, recruitment and career development.
• Represent the analytical team to senior leadership and customers.
• Drive continuous improvement and lead audit preparations and CAPA implementations.

Kenntnisse

Leadership

GMP compliance

Analytical chemistry

BioSpectroscopy

Regulatory compliance

Communication skills

Customer engagement

Problem solving

English fluency

German language (beneficial)

Ausbildung

Bachelor's degree in Analytical Sciences

Masters or PhD in protein chemistry or spectroscopy

Tools

CD spectroscopy

FTIR spectroscopy

Fluorescence spectroscopy

nDSC

AUC / Light scattering

SEC-MALS

UV spectrophotometry

SoloVPE

Jobbeschreibung

Job Description

Lead a high-performing analytical lab team driving cutting-edge bioanalytical CMC (characterization and late stage GMP) testing in the field of BioSpectroscopy including a wide variation of technologies in GMP-regulated drug development. Shape operations, inspire people, and deliver scientific excellence while partnering closely with customers and senior leadership.

Responsibilities

• Lead an analytical lab operations team, focusing on providing services in the field of BioSpectroscopy testing incl. Higher order structure (CD, FTIR, Fluorescence, nDSC), Aggregates (AUC, Light scattering, AF4-/SEC-MALS) and Concentration (SoloVPE, UV, polarimetry) in the context of CMC analytical drug development
• Personnel management of Analytical Manager, Scientists, Lab Technicians and ensure high-performance team execution
• Define priorities across lab sub-areas, ensuring effective workload distribution
• Oversee laboratory capacity planning, recruitment, and career development
• Promote a culture of collaboration, accountability, and operational excellence
• Ensure budget adherence and cost-efficient operation of laboratories
• Identify opportunities for cost-saving and process optimization
• Act as the primary liaison between the analytical team and senior leadership
• Represent the company in interactions with customers
• Ensure all analytical activities align with health, safety, environmental and GMP/ISO 9001 quality standards
• Drive continuous improvement initiatives to enhance compliance and efficiency
• Lead audit preparations and interactions, CAPA implementations

Qualifications

• Background in analytical CMC testing using BioSpectroscopy technologies under GMP
• Educational background in analytical sciences, protein chemistry, spectroscopy or a related field
• Industry experience (>5 years) in biopharmaceutical drug development environment, with a strong background in GMP-regulated analytical testing
• Proven industry leadership experience
• Expertise in regulatory compliance, analytical method development, and operational excellence
• Demonstrated ability to drive continuous improvement in analytical workflow processes
• High-level problem-solving, conflict resolution, and decision-making skills
• Strong ability to engage with customers
• Strong communication skills
• Fluent in English (additionally German is beneficial)