site found HR One - Executive search and project staffing

Job opportunities All vacancies

(Senior) Scientist CMC Analytical Development

Job description

For a biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics, we are looking for a (Senior) Scientist CMC Analytical Development to further strengthen the CMC team. The Scientist CMC Analytical Development will be responsible for the development and validation of analytical methods for testing and characterization of our therapeutic drug candidates throughout clinical development towards market approval. This is a unique opportunity to contribute to the development of novel therapeutics to treat patients with severe autoimmune diseases.

Reports to:

the Analytical Team Lead

Key Accountabilities and Responsibilities

Contributes to the CMC development of pre-clinical and clinical stage development programs in close collaboration with the CMC team members by:

- Drives the development and validation of analytical test methods for large molecules release and stability testing in accordance with the applicable regulatory requirements;

- Drives tech transfer of analytical methods between sites;

- Contributing to global analytical testing strategies with internal and external stakeholders;

- Supporting cross-site analytical oversight and harmonization;

- Contribute to analytical comparability testing strategies and protein characterization;

- Contribute to specification setting for development, pre-commercial and commercial stage programs;

- Contributing to strategic decision making on the basis of a deep understanding of protein behaviour;

- Contribute to statistical trending program to support specification setting and annual product quality reviews;

- Contributes to the write up of IMPD / IND / BLA quality dossier packages and drafting responses to health agency questions.

Skills and personality

- Strong technical expertise in analytical method development, validation and protein characterization; PhD or Master in Sciences;

- Strategic and rationale thinker; able to make data- based decisions;

- Team player; able to build effective relationships with internal and external stakeholders;

- Experience with writing/review of registration dossier sections is a plus (IND/IMPD/BLA/MAA);

- Excellent writing skills;

- Eye for detail and quality conscious attitude;

- Well-organised;

- Able to operate in a dynamic surrounding of a fast-growing biotech company with challenging timelines and changing priorities, flexibility is a must;

- Fluent in English – our working language;

Contract

Executive search

Experience

minimum 5 years

Education

Master's Degree

Languages

English

Sector

Pharmaceutical industry

Region

Ghent

Job type

Full-time

 
 

Submit your CV

Please submit your CV through the form below and we will contact you shortly.

 

HOW WE CAN HELP

Drop by for
coffee