R&D Senior Formulation Scientist ALRAZI

1. Job Objective

1.1 The main role of the R&D Senior Formulation Scientist is to research, develop, and optimize product formulations, ensuring compliance with GCC and SFDA requirements for safety, efficacy, and quality.

The Formulation Scientist will support research feasibility projects by conducting formulation evaluation and analytical characterization of products. Strict adherence to cGMP guidelines is required.

2. Duties, Responsibilities, and Authorities

2.1 Develop robust, stable, and effective formulations (solid oral and sterile) for in-house manufacturing based on the latest approaches such as QbD.

2.2 Comply with GMPs, SOPs, and all regulatory documentation.

2.3 Prepare manufacturing documentation for pilot/small production runs and scale-up operations.

2.4 Collect scientific data and references, maintain research documentation in pharmaceutical manufacturing, and prepare reports on developments in drug manufacturing and products.

2.5 Participate in the set-up and operation of pilot-scale equipment and instrumentation for small production runs in collaboration with the R&D technician.

2.6 Work with procurement and finance teams to select materials (excipients/medicinal ingredients) that meet financial goals and support cost-saving initiatives.

2.7 Optimize processes to improve manufacturing efficiencies.

2.8 Lead technology transfer and scale-up operations for in-house product manufacturing.

2.9 Participate in investigations of product failures including quality, potency, visual characteristics, and other parameters. Ensure involvement in all troubleshooting activities.

2.10 Develop and review Raw Material and Finished Product Specifications in collaboration with the Product Development Manager and QA/QC departments.

2.11 Initiate accelerated and ongoing stability studies for new products and review/report results in collaboration with the Product Development Manager.

2.12 Maintain the confidentiality of R&D data and company documents.

3. Education / Licensure

• Bachelor’s or Master’s degree in Pharmacy.

4. Professional Experience

4.1 Minimum of 7 years of experience in solid dosage forms (tablets, capsules, ODF) and sterile dosage forms (SVP and LVP) using BFS technology.

5. Core Competencies

5.1 Excellent organizational and planning skills. Strong written, verbal, and interpersonal communication skills. High attention to detail. Demonstrated analytical skills and the ability to work independently while managing multiple deadlines. Proficiency with Microsoft Office Suite and industry-related software.

6. Job Frequency

6.1 Everyday

7. Conditions

7.1 This job description becomes effective on the date of approval.

7.2 This job description is subject to periodic review and may be revised at any time in consultation with the committee supervisor and the employee.