The Formulation and Analytical Development Scientist is required to be technical leader in formulation projects and point of reference for Customers.
The scientist works with a multidisciplinary project team for the success of the project and customer satisfaction.
Main activities:
- Plan routine tasks and sample analyses to support formulation and process development including formulation buffers preparation, buffer exchange, analytical testing panel.
- Draw up Master Batch Record and Protocol describing process step, laboratory techniques, calculations, materials measurement, operation of laboratory equipment.
- In agreement with his Supervisor, is responsible for planning activities for the assigned projects in line with the related project plans.
- Guide Laboratory visits from Customers.
- Ensure adequate analytical support during formulations projects following method development or assessment for both biological and synthetic drugs.
- Ensure 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.
- Ensure quality standards, through verification/supervision of procedures within the laboratories.
- Exercise 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 both internal and customer use.
- Ensure the accurate management of analytical instruments in compliance with company procedures.
- Keep laboratory equipment in a state of efficiency.
HOW WILL YOU GET THERE?
Soft skills:
- Effectively communicate within the functions and with Client.
- Pro-active Approach to the problems.
- Ability to prioritize multiple tasks.
- Strong interpersonal and communication skills: active listening, effective message delivery, empathy, proactive attitude.
- Flexibility.
Education & Experience
- PhD, BA or MS in Chemistry/ Pharmacy/ Biological Sciences or similar.
- Experience with Lyophilization process development, formulation screening, optimization of filtration parameters
- 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.