Job description:
The Formulation and Analytical Development Scientist is required to be a technical leader in formulation projects and a point of reference for Customers.
He/She works with a multidisciplinary project team for the project's success and customer satisfaction.
Plans routine tasks and sample analyses to support the formulation and process development including formulation buffers preparation, buffer exchange, and analytical testing panel.
Draws up Master Batch Record and Protocol describing process step, laboratory techniques, calculations, materials measurement, operation of laboratory equipment.
In agreement with his Supervisor, He/She is responsible for planning activities for the assigned projects in line with the related project plans.
Guide Laboratory visits from Customers.
Ensures adequate analytical support during formulations projects following method development or assessment for both biological and synthetic drugs.
Ensures an adequate development of methods for identifying, quantifying, and resolving qualitative characteristics of IPC and finished products.
Collaborate with the FD/AD team sharing technical and scientific evaluations of analytical data for laboratory batches and associated studies.
Ensures quality standards, through verification/supervision of procedures within the laboratories.
Exercises independent judgment within defined procedures and practices to resolve appropriate action.
Draw up study protocols/reports/work instructions.
Prepare and/or verify technical documentation to support experimental work (ex: lab notebooks, batch records) for internal and customer use.
Ensures the accurate management of analytical instruments in compliance with company procedures.
Keeps laboratory equipment in a state of efficiency.
EDUCATION & EXPERIENCE
- PhD, BA or MS in Chemistry/ Pharmacy/ Biological Sciences or similar.
- Good knowledge of Microsoft Office (Microsoft Word, Excel, Powerpoint).
- Pharmaceutical background or previous experience in R&D Company.
- At least 3-5 years in technical field or in a related area (QC, AD,FD).
- English fluent.