Senior Formulation Scientist
1 week ago
Catalent Inc is seeking a highly skilled Senior Formulation Scientist to join our team in Somerset, NJ. As a key member of our Formulation team, you will be responsible for the development and implementation of hot melt extrusion technology for the creation of amorphous solid dispersions.
Key Responsibilities- Apply hot melt extrusion technology to enhance solubility and develop amorphous solid dispersions for oral dosage forms.
- Utilize scientific knowledge and hands-on skills in solid oral dosage form development, from preclinical to clinical formulations, process development, and scale-up.
- Transfer technology and processes, and provide technical support to the pilot plant, ensuring seamless execution of studies.
- Employ preformulation techniques, including DSC, TGA, XRPD, SEM, and hot stage microscopy, and interpret data to inform development decisions.
- Maintain high-quality GDP documentation, adhering to regulatory guidance and site SOPs, and contribute to SOP development and site policies.
- Apply problem-solving skills to complex issues, interpreting technical information and providing innovative solutions.
- Author technical documents, including specifications, project risk assessments, development reports, and data for clients.
- Apply project management skills to multiple, concurrent projects of high complexity, prioritizing tasks and suggesting alternatives or contingencies to achieve technical solutions efficiently.
- Develop strategies and tactics to support formulation development and lifecycle management, meeting regulatory milestones.
- Interpret data, including statistical analysis, design of experiments, and plotting/graphing tools, to present and explain development data.
- Bachelor's degree in Chemistry, Pharmaceutical Sciences, or a related field; Master's or PhD preferred.
- 12+ years of experience in formulation development of oral solid dosage, with a Bachelor's degree; 10+ years with a Master's degree; 5+ years with a PhD.
- 3+ years of hands-on experience with hot melt extrusion or amorphous solid dispersion development using relevant techniques.
- Technical skills in multiple formulation techniques, pharmaceutical manufacturing processes, and development strategies.
- Experience with twin screw melt granulation, twin screw wet granulation, process analytical technologies, and/or preformulation techniques preferred.
- Hands-on experience with DSC, TGA, XRPD, and hot stage microscopy preferred.
- Experience applying scientific principles and techniques, including organic chemistry, polymer chemistry, solid-state chemistry, and pharmaceutics, and common pharmaceutical processing techniques.
- Defined career path and annual performance review and feedback process.
- Diverse, inclusive culture.
- Positive working environment focusing on continually improving processes to remain innovative.
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
- Competitive compensation and benefits package.
- Opportunities for professional development and growth.
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