Cmc Analytical Lead
il y a 1 semaine
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx is translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx’s first experimental medicine, efgartigimod, is being evaluated in multiple autoimmune diseases, including myasthenia gravis (MG), immune thrombocytopenia (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP). argenx is located in Ghent, Belgium, Boston, Massachusetts and Tokyo, Japan.
PURPOSE OF THE FUNCTION
CMC Analytical Lead occupies a key role supporting Chemistry, Manufacturing and Controls (CMC) development for argenx therapeutic antibodies, ensuring that projects successfully move forward within and across functions. He/she drives internal and external efforts with the aim of developing, producing and characterizing these therapeutics antibodies for early and late stage clinical programs up to commercialization. He/she is responsible for technical mastery of scientific and technical documents as well as follow‐up on CMC project progress. The CMC Analytical Lead utilizes his/her expertise to resolve obstacles and bringing creative solutions to the table.
REPORTING LINE
Director CMC, analytical development
ROLES AND RESPONSIBILITIES
- Support of the set up of integrated CMC operational analytical development plans with external service providers (DS and DP manufactures and QC testing labs) by strategic thinking, providing expert input, and priority setting. Oversee the execution within agreed timelines, scope and budget.;
- Establish robust drug substance and drug product quality control strategy for release.
- Responsible for set up of ICH stability and reference standard programs throughout the development of a product;
- Establish and maintain a complete data repository in support of specification setting, expiry dating and shelf-life determination;
- Provide expert input into analytical method validation strategies, protocols and reports;
- As a member of the CMC development team actively contribute to technical and strategic CMC discussions;
- Identify and track project critical path items ‐ identify risks, formulate and monitor corrective actions related to analytical development of the product;
- Develop SOPs effectively describing CMC processes; Liaise with quality assurance on quality related matters
SKILLS AND COMPETENCIES
- Thorough knowledge and experience with GMP and in depth knowledge of ICH and GMP regulations;
- Works independently within the scope of his/her 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;
- 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 and product characterization, analytical method; development and validation; process validation and good understanding of statistics;
- 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
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