Senior Biologics Process Development Scientist (Sterile)

Scorpion Therapeutics; Pennsylvania; On-site; USD 140,000 - 200,000; Full time

Job summary

Scorpion Therapeutics in West Point, PA is seeking a Senior Scientist to lead sterile drug product process development for biologics pipelines, and to establish scalable, robust manufacturing processes for clinical and commercial programs.

The role involves designing studies, transferring to manufacturing sites, authoring regulatory documents, and supporting validation, lifecycle management, and regulatory filings; travel up to 25%.

Qualifications

• BS in chemical/biochemical engineering, microbiology, or related with 6+ years; MS with 4+ years; PhD with no experience.
• Experience in biologics process development, scale-up, and technology transfer.
• Proficiency with DOE, process validation, and regulatory document authoring.
• Preferred: sterile biologic manufacturing experience, cGMP, and QbD principles; project management.

Responsibilities

• Design and execute process studies, develop transfer strategies to manufacturing sites, author regulatory documentation, and support process validation and lifecycle management.
• Optimize processes for cost, robustness, and efficiency; and contribute to regulatory filings.

Skills

DOE

Process validation

Regulatory document authoring

Technology transfer

Scale-up

Biologics process development

Education

Bachelor's degree in Chemical/Biochemical Engineering, Microbiology, or related

Master's degree in Chemical/Biochemical Engineering, Microbiology, or related

PhD in a related field

Job description

Scorpion Therapeutics in West Point, PA is seeking a Senior Scientist to lead sterile drug product process development for biologics pipelines, and to establish scalable, robust manufacturing processes for clinical and commercial programs.

The role involves designing studies, transferring to manufacturing sites, authoring regulatory documents, and supporting validation, lifecycle management, and regulatory filings; travel up to 25%.