Job Purpose
We are looking for a qualified and motivated Formulator to join our Research & Development team and contribute to the development, optimization, scale-up, documentation, and lifecycle support of pharmaceutical products in accordance with applicable quality, cGMP, GLP, and ICH requirements.
Key Responsibilities
- Conduct activities related to the new product development process.
- Perform physical and chemical characterization of reference products.
- Conduct extensive literature searches to gather the required scientific and technical information related to pharmaceutical product development.
- Participate in the design and execution of pre-formulation and optimization studies.
- Perform small-scale formulation trials, analyze results, and support technical decision-making based on trial outcomes.
- Accurately document all development trials and activities according to approved timelines.
- Perform scale-up and pilot batches and related development activities.
- Coordinate with relevant departments to ensure smooth execution of R&D manufacturing activities.
- Coordinate with related departments to prepare and update technical documents for newly developed and existing products, including:
- Raw material specifications
- Release specifications
- Shelf-life specifications
- In-process specifications
- Manufacturing batch records
- Follow up with the Analysis Department to ensure project activities are progressing within agreed timelines.
- Ensure development activities are conducted in accordance with GLP and ICH guidelines.
CTD Documentation
- Prepare and maintain CTD documents related to pharmaceutical development activities.
- Ensure that R&D-related CTD documentation is accurate, complete, and updated as required.
R&D Documentation System
- Ensure complete and accurate documentation of all R&D batches and development activities.
- Review and update R&D documentation based on changes in processes, specifications, or applicable guidelines.
- Prepare, review, and maintain documents such as:
- Batch Manufacturing Records
- PVPs
- PVRs
- Development reports
- SOPs
- Handle applicable quality documentation requirements, including:
- Change controls
- Deviation reports
- Related quality documentation
Quality & Compliance
- Maintain and comply with applicable cGMP requirements within R&D.
- Ensure accuracy, traceability, and compliance of formulation-development records and documentation.
Qualifications & Requirements
- Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, or a related scientific field.
- A minimum of 2 years’ experience in formulation
- Good understanding of pharmaceutical formulation development.
- Knowledge of cGMP, GLP, and ICH guidelines.
- Familiarity with CTD documentation.
- Strong documentation, analytical, and problem-solving skills.
- Good communication and coordination skills.
- Excellent command of English.
- Ability to work effectively with cross-functional teams.
