Oral Dosage Formulator

Job Description

As a Oral Dosage Formulator, you will play a key role in developing and optimizing solid oral dosage forms. This includes:

1. Designing and implementing experiments to optimize formulation performance.
2. Collaborating with cross-functional teams to ensure seamless project execution.
3. Developing and maintaining technical documentation, including study protocols, reports, and batch records.
4. Supporting regulatory processes, including preparing submissions and reviewing guidance.
5. Ensuring compliance with quality control and assurance standards, including conducting QC tests and reviewing batch records.

Key Responsibilities

• Developing and optimizing solid oral dosage forms to enhance drug solubility and dissolution.
• Conducting dissolution studies in bio-relevant media to evaluate formulation performance.
• Supporting in vivo studies, including protocol design, implementation, and data analysis.
• Performing accelerated stability studies to assess formulation stability over time.
• Scaled up processes in collaboration with manufacturing teams and supporting cGMP manufacturing of clinical trial batches.

Education and Experience

• Degree in Pharmaceutical Sciences, Chemistry, or related field.
• 2-5 years of experience in formulation and/or pharmaceutical development with a focus on solid oral dosage forms and/or amorphous drug formulation.
• Experience with scale-up and commercialization.
• Proficiency in various characterization techniques, including but not limited to HPLC, DSC, and XRD.
• Previous experience of using statistical process control methodology.
• Strong problem-solving skills and the ability to analyze and interpret data.
• Excellent verbal and written communication skills, with the ability to effectively communicate with cross-functional teams.
• Ability to work independently and as part of a team.
• Project management skills and the ability to manage multiple projects simultaneously.