Manager, Senior Manager – Scientist CMC Analytical Development

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Oversee the implementation of the approved commercial supply plan for outsourced QC testing in collaboration with CMC commercial and Global supply teams.

• Receive external Certificates of Analysis (CoA) and Certificates of Compliance (CoC) and create internal specification documents for bulk drug substance and drug product.

• Manage change controls, deviations, and Out of Specification (OOS) investigations related to QC activities at external vendors.

• Assist with Out of Expectation (OOE)/Out of Trend (OOT) release and stability investigations, including root cause analysis and impact assessments.

• Engage in argenx investigation teams during meetings with external Contract Manufacturing Organizations (CMOs), providing specialized QC insights.

• Keep track of stock levels and the distribution of essential reagents and reference standards across QC laboratories.

• Monitor shipments and facilitate the prompt replenishment of critical reagents in accordance with regulatory requirements.

• Oversee reference standard trending and stability programs, and prepare retest-date statements.

• Maintain a comprehensive product-quality data repository using control charts for analytical critical quality attributes.

• Track annual stability trending within the validated shelf life.

• Supervise analytical method lifecycle activities, including transfers, protocols, reports, and performance trending across QC sites.

• Contribute to technical and strategic CMC discussions and review CMC Module 3 sections to support global submission strategies.

⛳️ Requirements

• Master's degree in chemistry, pharmaceutical sciences, bioengineering, or a related field within pharmaceutical/biotechnology sciences.

• Strong technical knowledge in the manufacturing of biological drug substances and drug products.

• Experience in analytical method development and validation.

• Familiarity with process validation techniques.

• Solid understanding of statistical methods.

• Proficiency in English, both written and spoken.

• Comprehensive knowledge and experience with Good Manufacturing Practices (GMP).

• Extensive understanding of ICH and GMP regulations.

• Capability to work independently within the designated area while supporting colleagues.

• Ability to stay updated on relevant scientific and technical advancements.

• Aptitude for detail-oriented work while keeping the overall project objectives in mind.

• Strong technical skills paired with effective project management capabilities.

• Excellent communication skills for engaging with internal and external stakeholders.

• Adaptable, quality-focused, and well-organized approach.

• Capacity to thrive in a dynamic, rapidly evolving biotech environment with demanding timelines.

• Team-oriented individual who can cultivate effective relationships with both internal and external partners.

🏝️ Benefits

• Reasonable accommodations for individuals with disabilities.

• Employment benefits and privileges.

• Opportunities for occasional domestic and international travel.