Senior Scientist DP Commercial

argenx

Ghent, Belgium

From € 80,000 up to € 110,000 per year

The Senior Scientist DP Commercial will be part of the DP commercial team, 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. This is a role with a global exposure.

REPORTING LINE

• Reports to the Drug Product & Device Commercial Manufacturing lead.

ROLES AND RESPONSIBILITIES

• He/She will be part of the DP commercial team;
• 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;
• Contributes in 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;
• Willing to travel (up to 30% of the time);
• 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.