Senior Scientist CMC - Drug Substance Sciences

argenx

Ghent, Belgium

To further strengthen our CMC DS Science MSAT team, we are looking for an experienced and motivated CMC Senior Scientist. He/she will play a key role supporting the BLA track of a late-stage drug substance (DS) manufacturing process at an external manufacturing partner (CMO) to enable process qualification and commercial manufacture of an argenx therapeutic antibody. Additionally he/she will also be the tech transfer lead for further scale up of the manufacturing process to a larger scale, when applicable.

Key Accountabilities and Responsibilities:

Expertise in process characterization studies (PCS) and process performance qualification (PPQ);
Review and approve PCS/PPQ protocols, Reports and supportive studies for PPQ;
Serve as Manufacturing/Technical point of contact on specific workstreams, leading teleconferences with CMOs and internal teams, following up with stakeholders on action items etc.;
Update project dashboards/presentations with project status to provide timely communication of status to internal team;
Work with internal and external leads and SMEs from Drug Product, Supply chain, Quality, Analytics and Manufacturing to support technology transfer of drug substance (DS) processes (upstream and downstream) to external manufacturing sites;
Review and approve tech transfer and manufacturing documentation such as risk assessments, facility fit analysis, gap analyses, batch records, process descriptions, and sample plans;
Work with CMOs to compile and trend DS manufacturing process data during tech transfer and manufacturing campaigns;
Facilitate the establishment of integrated CMC operational plans with internal and external service providers by providing expert input, problem resolution definition and priority setting and oversee their execution, scope and budget;
Review CMC DS sections to support timely submission of clinical trial applications and (s)BLA/MAA/J-MAA filings;
As a member of the CMC team actively contribute to technical and strategic CMC discussions;
Proactively identify and track project critical path items ‐ identify risks, formulate and monitor corrective actions and communicate risk to CMC leadership;
Work in close collaboration with quality assurance to ensure activities are performed in line with the required quality standards;
Provides input to budget forecast cycles.

Qualifications:

Master/PhD in chemistry, pharmaceutical sciences, bio‐engineering, or other discipline within pharmaceutical/biotechnology sciences;
Strong technical expertise in the field of biological drug substance manufacturing, tech transfer and scale up, process validation, or commercial manufacturing;
Expected experience: >5y within relevant industry;
Relevant experience in project management and outsourced activities;
Fluent in English, written and spoken;
In depth knowledge of ICH and GMP regulations;
Works independently within the scope of his/hers assigned field of expertise and supports others;
Keeps abreast with relevant scientific and/or technical developments;
Reviews literature and other technical resources independently and applies knowledge;
Excellent organizational and coordination skills;
Attention to 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 to balance multiple priorities;
Quality conscious attitude;
Experience and knowledge in the preparation of regulatory submissions;
Able to operate in a dynamic surrounding of a fast-growing biotech company with challenging timelines.