Group Leader Formulation and Production

Group Leader Formulation and Production

Employee Type
Description

The Formulation and Production Team plays a key role in the development of API-tailored formulations and transfer the technology into GMP, for clinical material production. The main task of the Group Leader Formulation and Production is the planning, preparation and follow up of the assigned formulation development and GMP production projects. The Group Leader Formulation and Production is responsible for the day-to-day management, planning and support of the Formulation Scientists and Production Operator performing formulation development and GMP production activities with the aim of facilitating progression of the activities, troubleshooting on technical issues and guaranteeing that the deliverables are met within budget and time and in accordance with the requirements of the GMP Quality system.

 

Main tasks:

* Planning, preparation and follow up of the assigned formulation development and GMP production projects;

• You function as scientific and technical problem solver in the Formulation and Production department;

• You function as representative of the formulation and production team in project core meetings;

• Translates the input from the Project Managers to tasks on the work-floor

• Review Technical Quality Agreement and drafts the internal instructions

• Draft and train Master Batch Record Documentation and Batch Record Documentation templates and ensure their strict use

• Coordinate the purchase and the availability of starting materials prior to start of GMP Production

• Plan and follow up the GMP Production activities, areas and equipment

• Assist the Production Operators in documenting non-conformances to guarantee the quality and compliancy

• Communicate with QA for follow up and strategy to be followed for nonconformances

• Responsible for resolving and discussing quality related issues with QA/QP

• Write the GMP manufacturing reports

• Support the Formulation Scientists in the execution of formulation projects

• Assist in meeting with Contract Givers

• You report to the Director Formulation and Production

 

Is it a local employment?
Country
Required Language
Requirements and Qualification

* Master’s degree or Ph. D. in a life science discipline e.g., pharmacy, biotechnology, biomedical sciences or similar. Affinity with drug development is a plus.

• Working experience with scientific and/or technical writing for chemical and/or biopharmaceutical products is a plus.

• Excellent writing and communication skills

• Fluent in English, written and spoken

• Customer-oriented and quality conscious attitude

• Eye for detail

• Proficiency with MS Office (mainly Word, Excel)

• Well organized and able to handle multiple projects in parallel

• Team player

 

http://www.areebajobs.com/

Years of Experience
3
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