Sr. Process Development Engineer - OSD

Scorpion Therapeutics; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking a senior process development scientist to lead OSD manufacturing development, transfer to pilot scale, and ensure robust, scalable processes. You will author CMC sections and collaborate with cross-functional teams to maintain cGMP compliance.

The role requires 3+ years post-PhD or longer, in pharma solid dosage processing, with strong leadership, communication, and problem-solving capabilities. Opportunity for impact in a fast-paced biotech setting.

Qualifications

• PhD with 3+ years, MS with 10+ years, or BS with 15+ years in engineering/scientific discipline in pharmaceutical solid oral dosage processing.
• Proficiency across powder blending, encapsulation, granulation, compression, and coating.
• Ability to work in fast-paced matrix environments and independently manage priorities/timelines.
• Collaborative leadership; strong verbal and written communication.
• Experience in small molecule process development, scale-up, and technical transfer.

Responsibilities

• Act as SME in oral solid dosage processing; adopt new technologies; provide technical guidance, training, and direction.
• Lead lab-scale process development; ensure knowledge transfer to pilot-scale via reports, presentations, and technical collaboration.
• Design and execute experiments to deepen process knowledge, optimize performance, and improve product robustness.
• Support GMP clinical manufacturing facility operations for OSD forms.
• Oversee GMP batch manufacturing at multiple scales, ensuring safety, quality, and documentation compliance.
• Create batch records, change controls, and SOPs with focus on efficiency and continuous improvement.
• Author CMC sections for IND, NDA, and other regulatory filings.
• Develop process trains/flows with scalable, reproducible processes and well-defined critical parameters.
• Maintain compliance with cGMP, safety, and environmental legislation and company policies.
• Present technical data; communicate risks/solutions; collaborate with formulators, engineers, safety, and quality teams.
• Mentor and train junior staff.

Skills

Process development

Team leadership

Communication

Problem solving

GMP knowledge

CMC documentation

Education

Ph.D. in engineering or related field

M.S. in engineering or related field

B.S. in engineering or related field

Tools

PAT

Job description

Responsibilities

• Act as SME in oral solid dosage (OSD) processing; adopt new technologies; provide technical guidance, training, and direction.
• Lead lab-scale process development; ensure knowledge transfer to pilot-scale via reports, presentations, and technical collaboration.
• Design and execute experiments to deepen process knowledge, optimize performance, and improve product robustness.
• Support GMP clinical manufacturing facility operations for OSD forms.
• Oversee GMP batch manufacturing at multiple scales, ensuring safety, quality, and documentation compliance.
• Create batch records, change controls, and SOPs with focus on efficiency and continuous improvement.
• Author CMC sections for IND, NDA, and other regulatory filings.
• Develop process trains/flows with scalable, reproducible processes and well-defined critical parameters.
• Maintain compliance with cGMP, safety, and environmental legislation and company policies.
• Present technical data; communicate risks/solutions; collaborate with formulators, engineers, safety, and quality teams.
• Mentor and train junior staff.

Qualifications

• Ph.D. +3 years; M.S. +10 years; B.S. +15 years in engineering/scientific discipline in pharmaceutical solid oral dosage processing.
• Proficiency across powder blending, encapsulation, granulation, compression, and coating.
• Ability to work in fast-paced matrix environments and independently manage priorities/timelines.
• Collaborative leadership; strong verbal and written communication.
• Experience in small molecule process development, scale-up, and technical transfer.

Preferred Requirements

• Design of experiments (DOE), data analysis, and interpretation.
• Understanding of drug development lifecycle and role of process development.
• Expertise in mechanical/chemical engineering principles applied to process systems and OSD equipment.
• Hands-on instrumentation/equipment installation and troubleshooting; process safety and risk assessment knowledge.
• Technical problem-solving using current research/technologies.
• Knowledge of ICH, FDA, and USP guidelines; apply by development stage.
• Process Analytical Technology (PAT) and drug product formulation experience.
• Minimal travel (10–15%).