Job Description
Purpose of the Role
The Senior Scientist in Analytical Method Development is a scientific leader responsible for driving the design, execution, and lifecycle management of robust analytical methods to support drug development, process optimization, and regulatory compliance. This role ensures the development and pre-validation of cutting-edge analytical techniques while mentoring junior staff, leading cross-functional projects, and aligning scientific strategy with business objectives. The incumbent serves as a subject matter expert (SME) for complex analytical challenges and contributes directly to regulatory submissions and innovation initiatives within a highly regulated environment.
Key Accountabilities
* Analytical Method Development & Pre-Validation
* Lead end-to-end development and pre-validation of complex analytical methods (e.g., HPLC, ELISA, CE, Mass Spectrometry) for drug substances and products.
* Serve as SME for advanced analytical technologies, providing strategic guidance to project teams and stakeholders.
* Design experimental plans (e.g., DOE) to optimize method robustness, specificity, and reproducibility.
* Documentation & Regulatory Compliance
* Author and review technical protocols, validation reports, SOPs, and regulatory submission documents (e.g., product dossiers).
* Ensure 100% compliance with GxP (Good Practice) regulations, data integrity standards (ALCOA+), and internal quality systems.
* Write and review GxP documentation (deviations, change controls) and escalate compliance issues proactively.
* Data Analysis & Scientific Rigor
* Analyze complex datasets using statistical tools (e.g., Minitab, JMP) to derive actionable insights.
* Present findings clearly to stakeholders via reports, presentations, and technical reviews.
* Uphold scientific rigor through reproducible methodologies and critical evaluation of results.
* Project & Stakeholder Leadership
* Manage complex analytical projects from scoping to delivery, including timelines, resources, and risk mitigation.
* Represent analytical development in cross-functional teams (R&D, QC, QA, Manufacturing) to align priorities.
* Influence strategic decisions through data-driven recommendations and innovation leadership.
* Laboratory Excellence & Innovation
* Oversee method development/pre-validation activities in laboratory settings.
* Support equipment qualification, calibration, and 5S/continuous improvement initiatives.
* Drive adoption of emerging technologies (e.g., AI/ML in data analysis) to enhance method efficiency.
* Talent Development & Knowledge Sharing
* Mentor Scientists, Associate Scientists, and Lab Technicians through technical guidance and career coaching.
* Lead onboarding, training, and competency development for analytical techniques and GxP compliance.
* Promote scientific curiosity via literature reviews, conference participation, and internal knowledge sessions.
Required Qualifications & Expertise
Education & Experience
Requirement
Details
Education
Master's degree
or
PhD in Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, or related field.
Work Experience
7+ years in analytical method development within
pharmaceutical/biotechnology R&D
, including:
* Full lifecycle management (development → pre-validation → transfer)
* Direct experience with regulatory submissions (e.g., EMA/FDA)
* Leadership of cross-functional projects
Regulatory Knowledge
Deep understanding of
ICH Q2(R1)
,
GMP
,
GLP
, and data integrity requirements.
Technical Competencies
* Advanced Proficiency in:
* HPLC/UPLC, CE, Mass Spectrometry, ELISA, UV-Vis, and related techniques.
* Method validation (specificity, accuracy, precision, robustness).
* Statistical analysis tools (Minitab, JMP, Design-Expert).
* Expertise in:
* Analytical method transfer and lifecycle management.
* Troubleshooting complex instrumentation and method failures.
* GxP documentation (protocols, reports, deviations, change controls).
Professional Skills
* Proven leadership in high-stakes project environments with matrixed teams.
* Exceptional communication skills (written/spoken) in English; fluency in French and/or Dutch preferred.
* Solution-oriented mindset with ability to simplify complex scientific concepts.
* Strong organizational skills to manage competing priorities in dynamic settings.
* Commitment to mentoring, collaboration, and continuous improvement.
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 1,000 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