Senior Development Scientist – Oral Solid Dose (OSD)

Hello,
I hope you're doing well.
My name is Pavani samboju, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Senior Development Scientist based Richmond, VA.in with one of our prestigious clients . I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at

pavani.samboju@intellectt.com

Role : Senior Development Scientist - Oral Solid Dose (OSD)
Location: Richmond, VA.
Rate: $45 on W2.
Experience:5+years

Key Skills
OSD Formulation | Formulation Development | Drug Product Development | QbD | DoE | Design Space | API & Excipient Characterization | Direct Compression | Wet Granulation | Dry Granulation | Continuous Manufacturing | Process Development | Scale-Up | Technology Transfer | Material Science | Root Cause Analysis | CMC | Data Analysis |Regulatory Compliance

Job Summary :
The Senior Development Scientist will lead formulation development, scientific experimentation, scale-up, and technical risk assessment for Oral Solid Dose (OSD)products. The role focuses on formulation science, material characterization, and process development to deliver robust, scalable, manufacturable, and regulatory-compliant products.

Key Responsibilities :

• Lead formulation design and development using Quality by Design (QbD), scientific principles, and material science.
• Develop and optimize prototypes and establish appropriate Design Space through structured experimentation.
• Evaluate API, excipient, and process parameter interactions to develop robust formulation strategies.
• Develop formulations using Direct Compression, Wet Granulation, Dry Granulation, and Continuous Manufacturing processes.
• Plan, execute, and interpret Design of Experiments (DoE) to evaluate Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs).
• Perform root cause analysis and resolve formulation and process-related issues.
• Perform or interpret characterization of raw materials and blends, including **Particle Size Distribution (PSD), microscopy, rheology, compatibility, moisture sorption, and compressibility.
• Develop scalable manufacturing processes and support **scale-up and technology transfer** activities.
• Partner with site technical and manufacturing teams to successfully transfer processes from laboratory to production.
• Prepare technical protocols, development reports, and **CMC Module 3 regulatory documentation**.
• Collaborate with **Analytical, Quality, Regulatory, Manufacturing, and R&D** teams to ensure technical alignment.
• Analyze scientific and process data and independently develop conclusions and recommendations.
• Present technical findings at internal R&D forums and external meetings.
• Manage project activities and communicate progress, risks, and recommendations to matrix leadership.

Required Qualifications :

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline.
• 5+ years of relevant experience in pharmaceutical formulation, drug product development, or OSD development.
• Strong knowledge of formulation science, process development, and material characterization.
• Experience with DoE, QbD, Design Space, and process optimization.
• Strong scientific problem-solving and data analysis skills.
• Knowledge of pharmaceutical drug development and regulatory requirements.
• Ability to work effectively across multidisciplinary teams.

Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

Equal Employment Opportunity:
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

Thanks & Regards,
Pavani Samboju
Technical Recruiter
Intellectt Inc

pavani.samboju@intellectt.com

Direct: 732 993 4972
Desk number: 732 412 6999- Ext: 137