Sr Scientist Product Lead CMC RA

Scorpion Therapeutics; Raritan (NJ); On-site; USD 120,000 - 160,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Scientist Product Lead CMC RA to drive regulatory chemistry, manufacturing and controls for innovative medicines across modalities. You will shape global CMC strategy and coordinate dossiers for development and marketed products, leading cross-functional teams to ensure timely filings and compliance.

The role requires a BS with 6+ years in pharma; advanced degrees are preferred and travel to multiple locations may be needed to ensure regulatory readiness and

Qualifications

• BS in biological, pharmaceutical, chemical, or engineering sciences with 6+ years in pharma.
• Advanced degrees (MS, PhD, or PharmD) preferred.
• Experience with CMC regulatory strategies and filings.

Responsibilities

• Develop global CMC regulatory strategies.
• Lead CMC across cross-functional teams.
• Prepare and coordinate regulatory dossiers.
• Support filings for development and marketed products.
• Drive compliance and continuous improvement.

Skills

CMC knowledge

Regulatory strategy

Cross-functional leadership

Regulatory submissions

Global health regs

Education

BS in relevant field

Tools

Regulatory databases

Job description

Role

Senior Scientist Product Lead CMC RA - Synthetics, New Modalities, focusing on regulatory chemistry, manufacturing, and controls (CMC) for innovative medicines.

Responsibilities

develop global CMC regulatory strategies, contribute as CMC Lead on cross-functional teams, prepare and coordinate regulatory dossiers, support filings for development and marketed products, manage country-specific documentation, and drive compliance and continuous improvement.

Requirements

BS in biological, pharmaceutical, chemical, or engineering sciences with 6+ years in pharmaceutical or healthcare sectors; advanced degrees (MS, Ph.D., Pharm.D.) preferred.

Skills

strong understanding of biology, chemistry, manufacturing processes; experience with drug development, analytical development, or manufacturing; excellent communication and regulatory knowledge of global health authority laws.

HighValue

CMC regulatory strategy, global filings, collaboration with therapeutic area teams, experience with regulatory inspections, applicable to biologics, synthetic or new modality products at various development stages.

WorkSetup

multiple US locations (Pennsylvania, New Jersey); flexible across Beerse, Belgium, or Warsaw, Poland; specific travel requirements not detailed.