Job SummaryThe Formulation Scientist in Technical Operations is responsible for developing, optimizing, and troubleshooting formulation processes for solid dosage forms, with a particular emphasis on capsule and tablet manufacturing. This role requires hands-on experience with encapsulation and compression machinery, along with expertise in formulating and scaling up products from R&D to commercial production. The ideal candidate will work closely with production, quality, and R&D teams to ensure that formulations meet regulatory standards and quality specifications.Key Responsibilities
- Process Development and Optimization: Design, develop, and optimize formulation processes for solid dosage forms, focusing on efficient encapsulation and compression techniques to ensure consistent product quality and compliance with regulatory standards.
- Equipment Operation and Troubleshooting: Operate and troubleshoot encapsulation and tablet compression machines, identifying and resolving technical issues to minimize downtime and ensure continuous production.
- Scale-Up and Validation: Collaborate with R&D to scale up lab-scale formulations to commercial production; develop process validation protocols and ensure manufacturing processes meet quality and regulatory requirements.
- Documentation and Compliance: Prepare detailed SOPs, batch records, and other documentation in compliance with cGMP and regulatory standards, maintaining meticulous records of process changes, troubleshooting, and product specifications.
- Collaboration and Cross-Functional Support: Work with cross-functional teams, including R&D, Quality, and Production, to provide technical support, troubleshoot formulation issues, and address deviations.
- Quality Control and Process Improvement: Monitor formulation processes, perform root cause analysis for any quality issues, and implement corrective actions to enhance process reliability, quality, and efficiency.
- Training and Knowledge Transfer: Provide training and guidance to production operators on proper equipment operation, troubleshooting, and maintenance of encapsulation and compression machinery.
Qualifications
- Education: Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field.
- Experience:
- 3-5 years of experience in formulation development within the pharmaceutical or nutraceutical industry.
- Hands-on experience with encapsulation and compression equipment operation and troubleshooting is required.
- Skills:
- In-depth knowledge of formulation science, process scale-up, and equipment validation.
- Strong troubleshooting skills for encapsulation and tablet compression machinery.
- Familiarity with regulatory and cGMP requirements for solid oral dosage forms.
- Excellent documentation, communication, and problem-solving skills.
Working ConditionsThis role primarily operates within a manufacturing environment and requires adherence to safety protocols and proper handling of pharmaceutical materials. This position may involve occasional lifting of equipment components and extended periods of standing or walking on the production floor.