Job Scope
Develop products as per the required standards and specification while meeting project timelines and set budget. Development tasks include literature review, pre-formulation, formulation and scale up and support analytical research activities according to the direction of the supervisor and the written SOPs
Job Requirements
Education
B.Sc. degree in Pharmacy
Experience
A minimum 3 years of relevant experience in pharmaceutical formulation
Language
Good written, read and spoken Arabic and English Languages
Professional Knowledge
- Knowledge in the systems such as ICH, GMP, GLP, GDP, WHO
- International Regulations
- Ministry of Health Regulations
- Knowledge in Registration Requirements
- Pharmacopeia
- Formulation development
- Process development
- Clinical studies protocols & requirements
- Stability protocols design
- Validation protocols design
Duties And Responsibilities (But Not Limited To)
- Develop new drug products as per the requirements of ICH Q8, Q9 and Q10 and other scientific guidelines where applicable.
- Conduct literature survey/Review.
- Conduct the relevant physical and chemical testing on the formulation trials.
- Prepare small-scale batches to evaluate product stability manufactured using prototype formula.
- Support relevant activities related to stress stability studies. This part is to be done in collaboration with analytical research department.
- Perform different experiments as per the direction of the supervisor to address formula optimization, formula reprocessing and full reformulation experiments for existing commercial products.
- Documentation of all formulation trials and test results using appropriate formats as per the relevant SOPs.
- Prepare a all documents required for submission including pharmaceutical development report, draft of the master drug product formula, Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).
- Scale up manufacturing process to pilot scale and/or production scale to support development activities and to prepare 3 stability batches to support submission activities as defined by the SOP.
- Implementation of current GLP and current GMP where applicable.
- Support manufacturing activities of the first 3 process validation batches at commercial scale post approval.
- Support the Analytical Development and the Regulatory Affairs in all required submission related inquiries and requirements.
- Follow & implement Good Laboratory Practice (GLP), Good Manufacturing practice (GMP) and Standard Operating Procedures (SOPs) when performing job related tasks.
