Plan and execute experiments in agreement with quality risk management and GDevP, GMP -Assists in the preparation of and reviews of the technological part of dossier
Excellent communication skills, a system oriented approach with exceptional leadership qualities. As a Second Line Manager, he will lead a motivated field staff, including Area Business Managers.
Conduct QC testing on raw materials, packaging, stability, in-process, and finished products. Capable of Handling Instrument like HPLC, GC, IR,UV instrument. Knowledge of Dissolution tester, KF, Potentiometer.
Advanced medical related graduate degree, such as: pharmacy, nursing with advanced clinical specialty Clinical Nurse Specialist, Nurse Practitioner, PhD with 1-3 years experience in related scientific field.
The Specialist, Regulatory Affairs Manager prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet companys and health authorities’ requirements.
Establish and lead the downstream group within the Biological Drug Substance Unit with process and operations-based expertise to support delivery of developed purification processes and of clinical batches of purified recombinant proteins
Clinical Data Analyst works under guidance and supervision of their Line Manager and/or Subject Matter Experts to perform some of the clinical data cleaning activities on assigned projects, commensurate with experience and, or project role.
Bachelors in Pharmacy or Masters in Chemistry, Sciences, Biotechnology ,Biomedical Engineering; Provide regulatory metrics on performance that are aligned with Area & GEM Regulatory Affairs criteria to measure regulatory performance to LOC, Area & Regional management