Sr. Development Scientist

Insight Global; Richmond (VA); On-site; USD 110,000 - 150,000; Full time

Job summary

Insight Global is seeking a Senior Development Scientist to lead formulation design and development for Oral Solid Dose products. You will drive rigorous experimentation, material characterization, and scale-up to robust manufacturing processes while ensuring regulatory compliance.

The role requires translating laboratory insights into scalable, robust processes and collaborating with Analytical, Quality, and Regulatory teams to align end-to-end development activities.

Qualifications

• Strong formulation science background and material characterization.
• Experience with design of experiments and process understanding.
• Regulatory knowledge and drug development process familiarity.

Responsibilities

• Lead formulation design and development using QbD principles.
• Develop prototypes, optimize formulations, and establish a Design Space.
• Evaluate API–excipients interactions for robust strategies.
• Develop Direct Compression, wet and dry granulation formulations as needed.
• Plan and interpret Design of Experiments to understand materials and processes.
• Apply root cause analysis to resolve formulation and process issues.
• Characterize raw materials and blends (PSD, microscopy, rheology, etc.).
• Design scalable manufacturing processes and transfer knowledge to sites.
• Prepare technical protocols, reports, and regulatory documentation (CMC).
• Collaborate with Analytical, Quality, and Regulatory teams; present findings.

Skills

Scientific rigor

Quality by Design

Material science

Education

Bachelor’s degree in pharmacy or Life Sciences

Masters or PhD in relevant discipline (preferred)

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