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
1. Reports to the Drug Product & Device Commercial Manufacturing lead
ROLES AND RESPONSIBILITIES
2. He/She will be part of the DP commercial team;
3. 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;
4. Contributes in resolving challenges as well as identifying opportunities to improve business processes and outcomes;
5. Manages production related deviations and change controls internally as well as externally with vendors;
6. Establishes and maintains continuous process verification processes;
7. Supports the annual product quality review process;
8. Manage Drug Product raw materials together with Supply Chain and external partners;
9. Perform Life Cycle Management and Continuous Improvement of manufacturing processes;
10. Provide technical support with the maintenance of registration documentation
11. Review and approve manufacturing specifications in coordination with relevant departments and CMOs;
12. Provision of subject matter expertise to support audit of manufacturing facilities in accordance with GMP, current guidelines and internal procedures;
13. Critical quality/technical review of CMC documents related to drug product manufacturing activities;
14. Proactively identify and track project critical path items ‐ identify risks, formulate and monitor corrective actions;
SKILLS AND COMPETENCIES
15. In depth knowledge of ICH and GMP regulations, FDA and EMA/CHMP guidelines, ISO standards and other international regulatory requirements;
16. Strong track record in parenteral drug Product manufacturing including combination products, secondary packaging and combination product assembly,
17. Strong problem-solving skills and mindset of continuous improvement;
18. Keep abreast with relevant scientific and/or technical developments. Searches literature and other sources independently and applies knowledge;
19. Excellent organizational and coordination skills;
20. Strong technical expertise combined with good project management skills and ability to communicate effectively with internal and external stakeholders;
21. Able to achieve great business outcomes with and through others;
22. Capable of building strong partnerships with external partners
23. Strong proactive communication skills
24. Quality conscious attitude;
25. Able to operate in a dynamic surrounding of a fast‐growing biotech company with challenging timelines;
26. Willing to travel (up to 30% of the time);
27. Fluent in English, written and spoken;
EDUCATION, EXPERIENCE AND QUALIFICATIONS
28. MSc or PhD in chemistry, pharmaceutical sciences, bio‐engineering, or other discipline within pharmaceutical/ biotechnology sciences;
29. 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;
30. Expected experience: >7y within relevant industry.
#LI-Onsite
The annual base salary hiring range for this position is €80,000.00 - €110,000.00 EUR
This job is eligible to participate in our short-term and long-term incentives program.
The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.