Main responsibilities
· Plane lead and execute pharmaceutical analytical experiments
· Responsible for development of characterization studies
· Responsible for validations of analytical methods and tech- transfer methods
· Management of CRO`s
· Author and review documents, reports, procedures.
· Scientific support to regulatory requirements and questions from regulatory authorities and e-CTD submissions
· Present information and data in both written
Required experience
· PhD, or MS in biotechnology, chemical engineering, life sciences or equivalent
· 3+ years of biopharmaceutical industry experience
· Knowledge in characterization studied of pharmaceuticals
· Knowledge in regulatory requirements and experience in regulatory responses
· Strong ability in execution and driving for results independently
· Detail oriented with good organizational skills and able to work in a high paced team environment to meet deadlines and prioritize work on multiple projects.
· Excellent communication skills, both verbal and written, and the ability to build and maintain relationships with team members, partners, customers, and collaborators.
· Fluent English in speaking and writing