Senior Development Scientist, Oral Solid Dose

SRG

Richmond (VA)

On-site

USD 120,000 - 180,000

Full time

18 hours ago
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Job summary

Impellam Group is seeking a Senior Development Scientist for our Oral Solid Dose (OSD) development program in Richmond, VA. The role leads formulation design, rigorous experimentation, and scale-up from lab to manufacturing with a focus on QbD and robust processes.

You will drive DoE studies, material characterization, and cross-functional collaboration to meet quality, performance, and regulatory standards. Advanced degree preferred; 5+ years of relevant experience strongly valued.

Qualifications

  • Bachelor's degree in Pharmacy or Life Sciences required.
  • 5+ years of relevant experience.
  • Master's or PhD preferred.
  • Knowledge of regulatory requirements and drug development.

Responsibilities

  • Lead formulation design and development using QbD and material science.
  • Develop prototypes, optimize formulations, and establish a Design Space through DoE.
  • Evaluate API-excipient interactions and process parameters for robust formulations.
  • Develop Direct Compression, wet/dry granulation, and continuous manufacturing formulations.
  • Plan, execute, and interpret DoE to understand material attributes and process parameters.
  • Apply root cause analysis to resolve formulation and process failures.
  • Characterize raw materials and blends (PSD, microscopy, rheology, moisture, compressibility).
  • Design scalable manufacturing processes and transfer knowledge to site teams.
  • Prepare technical protocols, reports, and CMC Module 3 regulatory documentation.
  • Collaborate with Analytical, Quality, and Regulatory teams; present findings internally and externally.
  • Communicate conclusions and next steps to matrix leaders.

Skills

Formulation design
DoE
Scale-up
Material characterization
Quality by Design
Regulatory compliance
Root cause analysis
Data analysis
Process understanding
Cross-functional collaboration

Education

Bachelor's degree in Pharmacy or Life Sciences
Master's, PhD or equivalent

Job description

Senior Development Scientist - Oral Solid Dose (OSD)

Shape the future of oral solid dose products. We're looking for a Senior Development Scientist to lead formulation design, scientific experimentation, and scale-up for our OSD portfolio - driving innovation from lab bench to manufacturing floor.

About the Role

As Senior Development Scientist on our Oral Solid Dose (OSD) development team, you'll drive formulation design, rigorous scientific experimentation, scale-up, and technical risk assessment for existing OSD products. You'll bring strong expertise in formulation science, material characterization, and process understanding - translating laboratory insights into scalable, robust manufacturing processes. This role serves as a scientific leader for OSD projects, ensuring our products meet the highest standards of quality, performance, manufacturability, and regulatory compliance.

What You'll Do

  • Lead 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
  • Evaluate interactions between API, excipients, and process parameters, translating that understanding into robust formulation strategies
  • Develop Direct Compression, wet and dry granulation, and continuous manufacturing formulations based on project needs
  • Plan, execute, and interpret Design of Experiments (DoE) to understand critical material attributes and critical process parameters
  • Apply root cause analysis to resolve formulation and process failures
  • Perform or interpret key characterization of raw materials and blends, including PSD, microscopy, rheology, compatibility, moisture sorption, and compressibility
  • Design scalable manufacturing processes and partner with site technical teams on knowledge transfer
  • Prepare technical protocols, reports, and regulatory documentation (CMC Module 3)
  • Partner with Analytical, Quality, and Regulatory teams to ensure end-to-end technical alignment
  • Present at internal R&D forums and external meetings
  • Independently develop and communicate conclusions and recommendations for next steps
  • Keep matrix leaders informed of progress and activities

What You'll Bring

Required:

  • Bachelor's degree in Pharmacy or Life Sciences
  • 5+ years of relevant experience

Preferred:

  • Master's, PhD, or equivalent practical experience in a relevant discipline
  • Knowledge of regulatory requirements and the drug development process
  • Strong problem-solving and scientific expertise
  • Experience analyzing data
  • Ability to influence and collaborate across teams

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.

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