Drug Product Device Commercial Manufacturing Lead (Remote)

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

The Drug Product & Device Commercial Manufacturing Lead will be responsible for ensuring timely supply of argenx drug product parenteral biologics portfolio.

He/she works with internal stakeholders and external partners to deliver the required global drug product mix on time. In doing so a strong technical mastery, priority setting, strong communication skills and mindset of excellence and continuous improvement will be key to be successful.

The Drug Product & Device Commercial Manufacturing Lead utilizes his/her expertise and network to identify and resolve challenges and look opportunities to improve processes and ultimately business outcomes. This is a role with a global exposure.

REPORTING LINE

• Reports to the Director DP Sciences CMC

Roles And Responsibilities

• Provides general management and control of external vendors in conjunction with the supply chain team in order to co-ordinate DP manufacturing activities inclusive of sterile fill finish, combination products and secondary packaging activities;
• Support development and execution of supply strategies for commercial programs, ensuring that the supply plans and regulatory plans are integrated and that capacity is aligned with current and anticipated future demand.
• Responsible for resolving challenges as well as identifying opportunities to improve business processes and outcomes;
• Manages production related deviations and change controls internally as well as externally with vendors;
• Establishes and maintains continuous process verification processes;
• Supports the annual product quality review process;
• Manage Drug Product raw materials together with Supply Chain and external partners;
• Perform Life Cycle Management and Continuous Improvement of manufacturing processes;
• Provide technical support with the maintenance of registration documentation
• Review and approve manufacturing specifications in coordination with relevant departments and CMOs;
• Provision of subject matter expertise to support audit of manufacturing facilities in accordance with GMP, current guidelines and internal procedures;
• Critical quality/technical review of CMC documents related to drug product manufacturing activities;
• Proactively identify and track project critical path items ‐ identify risks, formulate and monitor corrective actions;

Skills And Competencies

• In depth knowledge of ICH and GMP regulations, FDA and EMA/CHMP guidelines, ISO standards and other international regulatory requirements;
• Strong track record in parenteral drug Product manufacturing including combination products, secondary packaging and combination product assembly,
• Strong problem-solving skills and mindset of continuous improvement;
• Keep abreast with relevant scientific and/or technical developments. Searches literature and other sources independently and applies knowledge;
• Excellent organizational and coordination skills;
• Strong technical expertise combined with good project management skills and ability to communicate effectively with internal and external stakeholders;
• Able to achieve great business outcomes with and through others;
• Capable of building strong partnerships with external partners
• Strong proactive communication skills
• Quality conscious attitude;
• Able to operate in a dynamic surrounding of a fast‐growing biotech company with challenging timelines;
• Fluent in English, written and spoken;

Education, Experience And Qualifications

• MSc or PhD in chemistry, pharmaceutical sciences, bio‐engineering, or other discipline within pharmaceutical/ biotechnology sciences;
• Proven knowledge of / experience in GMP and working within a Quality Management System, Managing change controls, deviations, Commercial manufacturing and on-time manufacture of drug products as technical expert in cooperation with a QA and supply chain team;
• Expected experience: >7y within relevant industry.

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