Senior Scientist CMC

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets led by VYVGART our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company our partnerships our science and our people because when we do we deliver more for patients.

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 moveforward in time and within budget. He/she drives internal and external efforts withthe aim of developing producing and characterizing these differentiated antibodytherapeutics and is responsible for technical mastery of scientific and technicaldocuments as well as followup on CMC project progress. The CMC Senior Scientistutilizes his expertise to resolve obstacles and by bringing creative solutions to thetable.

2. REPORTING LINE

Report to Director CMC DP

3. ROLES AND RESPONSIBILITIES

Drives the execution of CMC activities for early and late phase drug developmentcandidates and changes to validated commercial processes;
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 scale-up activities;
Critical quality/technical review of CMC documents (e.g. process developmentprotocols/reports validation protocols/reports stability protocols/reports etc.) andbatch manufacturing records with minimal guidance and able to draw appropriateconclusions;
As a member of the CMC team actively contribute to technical and strategic CMCdiscussions;
Identify and track project critical path items identify risks formulate and monitorcorrective actions;
Support development and execution of supply strategies for clinical studies;
Prepare CMC sections to support timely submission of clinical trial applications;
Develop SOPs effectively describing CMC processes;
Liaise with quality assurance on quality related matters

4. 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. Searchesliterature 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 abilityto 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 withchallenging timelines;

5. EDUCATION EXPERIENCE AND QUALIFICATIONS

PhD in chemistry pharmaceutical sciences bioengineering or other discipline within
pharmaceutical / biotechnology sciences;
Strong technical expertise in the field of biological drug substance and drug product
manufacturing process characterisation and process validation; good understanding
of statistics;
Expected experience: 2-5y within relevant industry
Fluent in English written and spoke

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
Possibility to work remotely with limited travelling required


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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.

At argenx all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

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