Sr. Development Scientist
Insight Global
Job Description:
As Senior Development Scientist in our Oral Solid Dose (OSD) development team, you will drive formulation design, rigorous scientific experimentation, scale-up, and technical risk assessment for existing OSD products. The role requires strong expertise in formulation science, material characterization, process understanding, and translation of laboratory insights to scalable, robust manufacturing processes. The candidate will serve as a scientific leader for OSD projects, ensuring our products meet the highest standards of quality, performance, manufacturability, and regulatory compliance.
These responsibilities include some of the following:
· Leads the formulation design and development using principles of scientific rigor, Quality by Design and material science.
· Develop prototypes, optimize formulations, and establish a Design Space through structured experimentation and sound scientific rationale
· Evaluate interactions between API, excipients, and process parameters, and translate that understanding into robust formulation strategies
· Develop Direct Compression, wet and dry granulation and continuous manufacturing formulations depending on project needs
· Plan, execute and interpret Design of Experiments to understand critical material attributes and critical process parameters
· Apply root cause analysis methodologies to resolve formulation and process failures
· Perform or interpret key characterization of raw materials and blends, including PSD, microscopy, rheology, compatibility, moisture sorption, compressibility, etc.
· Design scalable manufacturing processes and partner closely with site technical teams to transfer knowledge
· Prepare technical protocols, reports, product development reports, and regulatory documentation (CMC module 3)
· Partner with Analytical, Quality and Regulatory team to ensure end-to-end technical alignment
· Present internal Research and Development forums and external meetings
· Independently prepares and communicates conclusions and recommendations for next steps
· Update matrix leaders informed of progress and activities
Basic Qualifications:
We are seeking professionals with the required skills to help achieve our goals:
· Bachelor’s degree in pharmacy or Life Sciences
· 5 + Years of experience
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
· Masters, PhD, or equivalent practical work experience in relevant discipline
· Knowledge of regulatory requirements and drug development process
· Strong problem-solving skills
· Scientific expertise
· Project management experience
· Experience analyzing data
· Ability to influence others
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