Analytical Development Executive (Senior specialist or Chief of department)

«ФАРМА ПЕРСОНАЛ»- спеціалізоване агентство

 Analytical Development Executive (Senior specialist or Chief of department)

 (LOCATION: TBILISI, GEO)

 FUNCTIONS:

The primary function for this position is to oversee and participate analytical development’s daily activities, such as method development and validation, analytical testing and stability program.

 RESPONSIBILITIES

• Supervise a group of analytical development scientists, and give guidance in their method development and validation, analytical testing, process support, stability and product evaluation.
• Review method validation plans and reports to assure that the methods meet requirements during different phases of product development.
• Direct activities and design experiments toward troubleshooting/optimization of existing analytical methods when necessary.
• Assure accurate and timely testing and reporting all results, issuing technical reports which include certification and validation data.
• Provide guidance on analytical investigations of abnormal results.
• Work in collaboration with other departments, e.g. Process, Formulations, Regulatory Affairs, Production, Supply Chain, etc, to support timely new product development and submissions.
• Work with contract laboratories and collaborators.
• Participate in selection, evaluation and development of new personnel.

QUALIFICATIONS

• PhD or Master Degree in Chemistry, Pharmaceutical Sciences or related fields. Master with over 8 years of experience and PhD with over 3 years of experience in the pharmaceutical analytical chemistry.
• Working knowledge of major analytical techniques. Ability to train scientists on new techniques.
• Strong experience with analytical development in pharmaceutical development, including method development, validation, stability and in-process control within CMC.
• Familiar with pharmaceutical industry regulations and EMA/FDA/ICH guidelines
• Proven supervisory experience.
• Good analytical skills in sorting information, formatting directions and problem solving.
• Good communication skills and English language ability.

 Пропозиція компанії: оговорюється індивідуально

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