Senior Scientist CMC

argenx; Gent; Hybride; EUR 65 000 - 85 000; Plein temps

Avantages offerts par ce poste

Competitive salary package

Extensive benefits

Remote work possibility

Résumé du poste

A leading biotech company located in Gent, Belgium, is seeking a Senior Scientist CMC to support Chemistry, Manufacturing, and Controls (CMC) development. The ideal candidate will have a PhD in a relevant field and 2-5 years of experience in the biotech industry. This role involves driving CMC activities, facilitating operational plans, and ensuring compliance with GMP standards. The position offers a competitive salary, extensive benefits, and the possibility for remote work. Join a dynamic and rapidly growing team dedicated to transforming immunology for patients.

Qualifications

• 2-5 years of experience in the biotech industry.
• Experience in preparation of regulatory submissions.
• Fluent in English, both written and spoken.

Responsabilités

• Drive CMC activities for drug development candidates.
• Facilitate operational plans with external service providers.
• Lead drug product site transfer and scale-up activities.

Connaissances

GMP knowledge

Project management

Technical expertise

Organizational skills

Quality conscious

Formation

PhD in chemistry, pharmaceutical sciences, or related field

Description du poste

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

Purpose of the Function

A senior scientist CMC plays a key role supporting Chemistry, Manufacturing and Controls (CMC) development of Argenx drug products, ensuring that projects move forward in time and within budget. He/she drives internal and external efforts with the aim of developing, producing and characterizing these differentiated antibody therapeutics and is responsible for technical mastery of scientific and technical documents as well as follow‑up on CMC project progress. The CMC Senior Scientist utilizes his expertise to resolve obstacles and by bringing creative solutions to the table.

Reporting Line

Report to Director CMC DP

Roles and Responsibilities

• Drives the execution of CMC activities for early and late phase drug development candidates and changes to validated commercial processes;
• Facilitate the establishment of integrated CMC operational plans with external service providers by providing expert input, problem resolution definition and priority setting and oversee their execution within agreed timelines, scope and budget; external service providers include drug product manufacturing, pack & labelling and analytical testing services;
• Leads drug product site transfer and scale‑up activities;
• Critical quality/technical review of CMC documents (e.g. process development protocols/reports, validation protocols/reports, stability protocols/reports, etc.) and batch manufacturing records with minimal guidance and able to draw appropriate conclusions;
• As a member of the CMC team actively contribute to technical and strategic CMC discussions;
• Identify and track project critical path items – identify risks, formulate and monitor corrective actions;
• Support development and execution of supply strategies for clinical studies;
• Prepare CMC sections to support timely submission of clinical trial applications;
• Develop SOPs effectively describing CMC processes;
• Liaise with quality assurance on quality related matters;

Skills and Competencies

• Thorough knowledge and experience with GMP;
• Works independently within the scope of his assigned field and supports others;
• Keep abreast with relevant scientific and/or technical developments. Searches literature and other sources independently and applies knowledge;
• Excellent organizational and coordination skills;
• Ability to go into detail whilst keeping the view on the overall project goal;
• Strong technical expertise combined with good project management skills and ability to communicate effectively with internal and external stakeholders;
• Flexible attitude, capable of picking up the tasks that require attention;
• Quality conscious attitude;
• Experience and knowledge in the preparation of regulatory submissions;
• In depth knowledge of ICH and GMP regulations;
• Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines;

Education, Experience and Qualifications

• PhD in chemistry, pharmaceutical sciences, bio‑engineering, or other discipline within pharmaceutical / biotechnology sciences;
• Strong technical expertise in the field of biological drug substance and drug product manufacturing, process characterisation and process validation; good understanding of statistics;
• Expected experience: 2‑5y within relevant industry;
• Fluent in English, written and spoken;

Offer

• A competitive salary package with extensive benefits;
• Front seat in the development of therapeutic antibodies;
• A work environment in a human‑sized, dynamic and rapidly growing biotech company;
• Possibility to work remotely with limited travelling required;

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

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