Sr Scientist Product Lead CMC RA

Scorpion Therapeutics; Horsham (PA); On-site; USD 150,000 - 190,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Scientist Product Lead in CMC Regulatory Affairs, focusing on synthetics and new modalities. You will drive global regulatory strategies and dossier development for innovative medicines in a senior capacity.

The role emphasizes collaboration with development, manufacturing, and regulatory groups to ensure compliant filings and regulatory success across regions.

Qualifications

• BS with 6+ years industry experience; advanced degree preferred.
• Experience coordinating regulatory CMC plans and dossiers.
• Strong collaboration across regulatory, development and manufacturing.

Responsibilities

• Develop and implement CMC regulatory plans for development and marketed products.
• Lead Regulatory CMC on cross-functional teams and guide submissions.
• Prepare regulatory dossiers for global submissions and health authority interactions.

Skills

Biology knowledge

Chemistry knowledge

Engineering knowledge

Drug development experience

Cross-functional collaboration

Education

Bachelor's degree in biosciences/chem/engineering

Advanced degree (MS/PhD/PharmD) preferred

Job description

Role: Senior Scientist Product Lead in CMC Regulatory Affairs specializing in Synthetics and New Modalities, supporting global regulatory strategies and dossier development for innovative medicines.

Responsibilities: develop and implement CMC regulatory plans for development and marketed products, serve as the Regulatory CMC Lead on cross-functional teams, prepare and coordinate regulatory dossiers for global submissions, and support health authority interactions and inspections. Ensure compliance with global regulations and drive continuous improvement.

Qualifications:

• BS in biological, pharmaceutical, chemical, or engineering sciences with 6+ years of industry experience; MS, Ph.D., or Pharm.D. preferred.

Skills:

• strong understanding of biology, chemistry, and engineering relevant to pharma; experience in drug development, analytical development, or manufacturing; excellent communication and cross-functional collaboration skills.

High-Value: focus on innovative medicines, including biologics or new modalities, with responsibilities spanning development through lifecycle management, supporting global filings and regulatory strategies.

Work setup: multiple US locations (Pennsylvania, New Jersey), with potential for international postings in Belgium or Poland.