Job description
Your Mission
Join our Scientist GMP analytical team to develop, validate, and transfer using Karl Fisher (measure water content in pharmaceutical raw materials, active ingredients, and finished drug products) and Liquid Chromatography (LC) methods that guarantee the purity and safety of next-generation therapies. You will own water-content testing workflows and high-resolution liquid-chromatography assays for small molecules, peptides, and oligonucleotides, ensuring every batch meets stringent regulatory standards before reaching patients.
Key Responsibilities
• Karl Fischer Expertise: Design, validate, and execute KF titration methods (volumetric & coulometric) for APIs, excipients, and drug products; troubleshoot instrument drift, side reactions, and matrix effects.
• LC Method Development: Develop and validate U/HPLC assays for potency, impurities, and stability indicating methods; perform method transfers to QC and CMO partners.
• GMP Compliance: Author protocols, reports, and SOPs; review data for ALCOA+ principles; support regulatory inspections and deviations/CAPA.
• Cross-functional Collaboration: Partner with Process Chemistry, Formulation, and QA to align analytical strategies with project milestones.
• Continuous Improvement: Evaluate new KF reagents, columns, and LC technologies to increase throughput and reduce cost-of-goods.
Must-Have Qualifications
• BSc/MSc in Chemistry, Analytical Chemistry, or related field.
• 2+ years’ hands-on experience with Karl Fischer titration in a GMP pharmaceutical environment.
• Proven track record in liquid-chromatography method development and validation (HPLC/UPLC).
• Strong documentation skills in English; familiarity with ICH Q2(R1), USP <921>, and FDA/EMA guidelines.
Nice-to-Have
• Experience with Empower CDS, Agilent OpenLab, or similar chromatography data systems.
• Knowledge of LC-MS, IC, or other orthogonal techniques.
• Exposure to stability studies and regulatory filings (IND, IMPD, NDA).
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!