Principal Engineer, Process Development - OSD

Scorpion Therapeutics; United States; On-site; USD 173,000 - 193,000; Full time

Benefits offered by this job

Competitive benefits package

Annual performance pay bonus

Job summary

Scorpion Therapeutics seeks a senior Process Development leader to guide small-molecule development, scale-up, and tech transfer. You will oversee DoE, product characterization and control strategy while collaborating with Development and Manufacturing teams to maximize external partnerships.

You will manage external CDMOs, mentor junior staff, and ensure compliance with ICH, FDA, and USP guidelines throughout late-stage development.

Qualifications

• PhD or MS in Science or Engineering with substantial relevant experience.
• Expertise in small-molecule process development, scale-up and tech transfer.
• Proficient in DoE, data analysis and data interpretation.
• Experience managing contract drug development (CDMO) activities.
• Strong problem-solving using current research and technologies.
• Broad understanding of drug development and process development role.
• Collaborative leadership with strong verbal and written communication.
• Expert understanding of ICH, FDA and USP guidelines; apply by development stage.
• Proficiency with powder blending, granulation, compression, encapsulation, coating.
• Ability to work in a fast-paced matrix environment; manage priorities.
• Process Analytical Technology (PAT) experience preferred.

Responsibilities

• Provide subject matter expertise in process development methodologies and oversight.
• Guide process development, DoE, product characterization and control strategy.
• Design and execute ICH/FDA-aligned activities for late-stage small-molecule development.
• Collaborate with Pharmaceutical Development and Manufacturing to leverage capabilities.
• Provide timely technical support and management oversight for external partners.
• Develop/review/approve process development source documents for regulatory submissions.
• Present data to cross-functional teams and senior management; address critical issues.
• Identify and advocate new/emerging process development technologies.
• Manage, train and mentor junior Process Development staff.
• Perform other duties as assigned.

Skills

Process development leadership

DoE

Data analysis

Technical transfer

CDMO management

Regulatory knowledge

Cross-functional communication

Education

PhD or MS in Science or Engineering

Job description

Responsibilities

• Provide subject matter expertise in process development methodologies for internal/external execution and technical oversight.
• Guide and drive process development, design of experiments (DoE), product characterization, and control strategy development.
• Design and execute ICH/FDA-aligned process development activities for late-stage small-molecule development (Phase 3 to PPQ).
• Collaborate with Pharmaceutical Development and Manufacturing to leverage internal/external capabilities.
• Provide timely technical support and management oversight for process development activities at external partners.
• Develop/review/approve process development source documents; author/review drug product process development sections for regulatory submissions.
• Present technical data to cross-functional teams and senior management; communicate critical process issues and solutions.
• Identify and advocate new/emerging process development technologies.
• Manage, train, and mentor junior Process Development staff.
• Perform other duties as assigned.

Qualifications

• PhD (>8 years) or MS (>15 years) in Science or Engineering.
• Demonstrated expertise in small-molecule process development, scale-up, and technical transfer.
• Expertise in DoE, data analysis, and data interpretation.
• Experience managing contract drug development (CDMO) activities.
• Strong technical problem-solving using current research and technologies.
• Broad understanding of the drug development process and process development’s role.
• Collaborative leadership; strong verbal/written communication.
• Expert understanding of ICH, FDA, and USP guidelines; ability to apply by development stage.
• Proficiency with powder blending, granulation, compression, encapsulation, Wurster coating, pan coating.
• Ability to work in a fast-paced matrix environment and independently manage priorities/timelines.
• Process Analytical Technology (PAT) experience preferred.

Travel Requirements

Travel as needed; serve as primary technical representative during critical manufacturing activities and provide onsite leadership during scale-up, technology transfers, validation, troubleshooting, and key milestones.

Compensation/Benefits (as stated)

Base salary: $173,000–$193,000; eligible for annual performance pay bonus; competitive benefits package.