Senior Scientist Cmc - Gent, België - Argenx

Argenx

Geverifieerd bedrijf

Gent, België

2 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

1. PURPOSE OF THE FUNCTION

A senior scientist CMC plays a key role supporting Chemistry, Manufacturing and Controls (CMC) development of Argenx drug products, ensuring that projects move forward in time and within budget.

He/she drives internal and external efforts with the aim of developing, producing and characterizing these differentiated antibody therapeutics and is responsible for technical mastery of scientific and technical documents as well as follow‐up on CMC project progress.

The CMC Senior Scientist utilizes his expertise to resolve obstacles and by bringing creative solutions to the table.

REPORTING LINE

Report to Director CMC DP

ROLES AND RESPONSIBILITIES
Facilitate the establishment of integrated CMC operational plans with external

service providers by providing expert input, problem resolution definition and

priority setting and oversee their execution within agreed timelines, scope and

budget; external service providers include drug product manufacturing, pack &
labelling and analytical testing services;

Leads drug product site transfer and scaleup activities;
Critical quality/technical review of CMC documents (e.g. process development protocols/reports, validation protocols/reports, stability protocols/reports, etc.) and batch manufacturing records with mínimal guidance and able to draw appropriate conclusions;
As a member of the CMC team actively contribute to technical and strategic CMC discussions;
Identify and track project critical path items ‐ identify risks, formulate and monitor corrective actions;
Support development and execution of supply strategies for clinical studies;
Develop SOPs effectively describing CMC processes;
Liaise with quality assurance on quality related matters
SKILLS AND COMPETENCIES
Thorough knowledge and experience with GMP
Works independently within the scope of his 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;
Experience and knowledge in the preparation of regulatory submissions;
In depth knowledge of ICH and GMP regulations;
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