Senior Analytical Chemistry Consultant (BBBH186) Basel, Switzerland
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KVALITO Life Science Consultant, Senior Analytical Chemistry Consultant
Location: Remote (Switzerland-based preferred)
Type: Part time
Mission:
The core mission of the Senior Analytical Chemistry Consultant is to provide expert-level knowledge and practical guidance to support analytical activities across global pharmaceutical business operations. This role is critical in driving compliance, innovation, and efficiency in analytical method validation, transfer, and lifecycle management. The consultant will serve as a trusted advisor, ensuring alignment with the latest regulatory standards and contributing to the continuous improvement of analytical processes.
Key Accountabilities:
- Provide expertise in analytical method validation, transfer, and specification setting.
- Revise frameworks and templates to meet new ICH Q2(R2) requirements.
- Ensure alignment of analytical strategies with global business objectives.
- Create, update, and review regulatory submissions, SOPs, and analytical governance documents.
- Ensure compliance with global and regional regulatory guidelines.
- Address deviations, out-of-specifications (OOS) issues, and technical challenges (e.g., ghost peaks).
- Develop systematic approaches for complex analytical methods (e.g., titration, KF methods).
- Advise on late-phase project governance, including pre-review of analytical methods for key gate meetings.
- Drive the development of tools like Analytical Strategy Documents and templates for trending.
- Integrate sustainable and green chemistry principles into method optimization.
- Maintain state-of-the-art knowledge through benchmarking, publications, and conferences.
- Act as an interface for key technical areas, such as mutagenic/nitrosamines investigations, ensuring collaboration across departments.
Key Qualifications:
- 20+ years of experience in analytical chemistry, with a strong focus on pharmaceutical or life sciences industries.
- Advanced knowledge and hands-on experience with analytical method validation, transfer, specification setting, and lifecycle management.
- Proven ability to navigate complex regulatory landscapes, ensuring compliance with ICH guidelines (e.g., ICH Q2(R2)), GMP, and global/regional regulatory requirements (e.g., EMA, FDA).
- Experience in authoring, reviewing, and optimizing SOPs, analytical reports, and regulatory submission documents for complex pharmaceutical products.
- Proficiency in systematic method development for techniques such as titration methods, KF (Karl Fischer) methods, and residual solvent analysis.
- Familiarity with analytical lifecycle management and cross-functional processes within global pharmaceutical organizations.
- Experience supporting late-phase and commercial projects, particularly in governance and analytical strategy development.
- Expertise in managing complex investigations, such as those involving mutagenic impurities, nitrosamines, and other critical contaminants.
- Knowledge of emerging regulatory trends and their implications for analytical methods and pharmaceutical development.
Key Competencies:
- Ability to address complex analytical challenges and implement practical solutions.
- High level of precision in documentation and regulatory submissions.
- Skilled in cross-functional collaboration and stakeholder management.
- Passion for integrating industry trends and sustainability into analytical strategies.
- Capable of managing projects effectively to meet deadlines and business goals.
We offer great benefits
- Flat hierarchies and responsibility from the beginning
- People-oriented culture
- Diversity and inclusion-focused environment
- Global client projects in a multinational environment
- Flexible working hours and home office
- Involvement in global conferences
- Individual professional development, training, and coaching
- Unlimited full employment contract
- Excellent remuneration package consisting of a competitive salary plus a substantial bonus
If you are a self-motivated and reliable professional who enjoys a hands-on role in business operations, please submit your CV and a cover letter
We look forward to hearing from you!