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
Collaboration with internal and external media to ensure the proper execution of strategies. Providing training, product knowledge, and direction to the field sales team to ensure that they are well-equipped with scientific and communication skills both.