Job Description
R&D Pharmaceutical Formulation Scientist Overview We are seeking an experienced R&D Formulation Scientist with expertise in developing innovative pharmaceutical formulations, performing stability and efficacy tests, and ensuring regulatory compliance. This role includes the transition of lab formulations to pilot and production scales. The ideal candidate would have been previously cross-trained in analytical chemistry or quality control.
Responsibilities: Formulation Development Experience: - Design and develop new pharmaceutical formulations, including tablets, capsules, and liquids.
- Conduct pre-formulation studies to understand the properties of active pharmaceutical ingredients (APIs) and excipients.
- Optimize formulations for stability, bioavailability, and patient compliance.
Regulatory Compliance: - Ensure all formulations comply with regulatory standards and guidelines.
- Understand 21 CFR FDA drug compliance requirements
Testing and Analysis: - Perform HPLC stability testing, dissolution testing, and other necessary tests to ensure the efficacy and safety of formulations.
- Create prototypes and samples for further testing and evaluation.
- Analyze data and interpret results to guide formulation development.
- Document all experiments and results accurately and comprehensively.
Quality Control and Assurance :
- Ensure all formulations meet internal quality standards.
- Implement and maintain quality control processes throughout the formulation development phase.
Collaboration and Communication: - Work collaboratively with cross-functional teams, including quality control, regulatory affairs, and production.
- Communicate project status, challenges, and results to stakeholders effectively.
- Stay updated with the latest advancements in pharmaceutical formulation and regulatory requirements.
Project Management: - Manage multiple projects simultaneously, ensuring timelines and budgets are met. •Identify potential risks and develop mitigation strategies.
- Prepare project reports and presentations for internal and external stakeholders.
Qualifications
- Education: Bachelor's degree in chemistry, Biochemistry, or a related field.
- Experience: Minimum of 3-5 years of experience in pharmaceutical formulation development.
- Skills:
- Strong knowledge of pharmaceutical formulation principles and practices. o Proficiency in using formulation and analytical equipment.
- Excellent problem-solving and analytical skills.
- Strong organizational and project management abilities.
- Effective communication and interpersonal skills.
- Knowledge of regulatory requirements and guidelines.
Work Environment - Laboratory and office settings.
- May require handling of hazardous materials and adherence to safety protocols.
- Collaboration with team members and departments to achieve project goals.
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