Καριέρα

Rontis, a Swiss multinational healthcare company, is looking to hire:

ANALYTICAL DEVELOPMENT MANAGER

based in Athens, Greece:

Positioning Analytical Development Manager reports to: Analytical Development Director, in case of absence to Formulation Development Director and Business Development Director. Employees that report to the Analytical Development Manager: Analytical Development Junior/Senior Manager, Analytical Development Coordinator, Analytical Development Principal Scientist, Analytical Development Senior Scientist, Analytical Development Scientist, Analytical Development Assistant. Required Qualifications

• University Degree in Chemistry or Pharmaceutical Studies (with strong chemistry content).
• Previous experience of at least 3 years in relevant position and at least 3 years of previous experience in the development and validation of analytical methods.
• Excellent knowledge and handling of both verbal and written English language.
• Good knowledge of MS Office suites (Word, Excel, Power Point, Outlook).
• Ability to work accurately in a busy and demanding environment, adhering to strict deadlines/timescales. Strong analytical and problem solving ability.

Scope of the Position The Analytical Development Manager is responsible for the analytical activities of the Analytical Development Department. Primary responsibilities include: Management of the routine analytical laboratory operation, Overview of the analytical methods development, optimisation and validation, Overview of stability testing and quality control testing of new pharmaceutical formulations and Performance of analytical investigations and analytical problem solving. Responsibilities

• Planning and supervision of all analytical development activities.
• Developing and validating robust analytical test methods to support formulation development for manufactured ‘specials’ to Good Manufacturing Practice (GMP) and ICH Q2 requirements.
• Preparing analytical method development, validation and analytical investigation reports.
• Analytical support and solving complex analytical chemistry problems to facilitate product development activities
• Analytical Method and Process Validation Protocol writing or reviewing or approving.
• Development, improvement and checking of analytical methods.
• Collaborating with Formulation Development Department for the effective development of new products ensuring delivery in accordance to project timescales and deadlines set by Formulation Development Department
• New APIs monographs compiling according to DMF or Pharmacopoeia monographs and managing of API analytical methods validation or transfer.
• Over viewing the Analytical Development training plan.
• Purchasing, validating and maintaining equipment for analytical development activities.
• Controlling laboratory chemicals required for analytical development activities.
• Planning and organizing stability testing for products for new formulations.
• Writing or reviewing specifications and methods of analysis.
• Compiling, reviewing and implementing, where deemed, appropriate Standard Operating Procedures, SOPs.
• Ensuring that the laboratory safety rules are followed by all employees of the Analytical Development Department.
• Performance appraisal of personnel reporting to the Analytical Development Manager, generated on an annual basis.
• Ensuring cooperation with all members of staff to maintain and develop the positive progressive culture within the Laboratory.
• Approval of Analytical Development department supply requirements.
• Designing or approving of electronic databases and hardcopy templates relevant to Analytical Development activities.
• Evaluation of analytical equipment requirements, as well as characterisation of instrument requirements, according to current or potential analytical development needs and proposing thereof the supply for investment approval.
• Routine checking of Pharmacopoeia (EP, USP) or ICH guidelines for updates that should be incorporated at the department.
• Ensuring compliance with Good Manufacturing Practice (GMP), company Health and Safety Policies, Standard Operating Procedures (SOPs).
• Contributing to and preparing CMC Analytical development sections for MAA applications.
• Transferring new analytical techniques to the Quality Control (QC) laboratory.
• Evaluation of Analytical Development progress in respect to set goals and generating reports for submission to the Analytical Development Director, in case of absence to Formulation Development Director and Business Development Director.
• Acting on behalf of the Analytical Development Director regarding the Analytical Development related responsibilities.

This is a full-time position. Only candidates meeting the criteria above will be contacted

Candidates are kindly requested to send their CV to hr@rontis.com