Associate Director, Sterility Assurance

Scorpion Therapeutics; Hopewell (NJ); On-site; USD 160,000 - 210,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Director of Sterility Quality Assurance to lead the sterility assurance and contamination control programs at our Hopewell, NJ site, ensuring compliance with cGMP, FDA, and global standards.

You will oversee aseptic processing, environmental and personnel monitoring, cleaning, sterilization, and process validation, while guiding investigations of sterility-related events and supporting inspections and tech transfers.

Qualifications

• Bachelor's degree with 8+ years in microbiology or biological QA, preferably in large molecule sterile manufacturing within an FDA-regulated biotech/pharma environment.
• Experience with regulatory inspections, contamination control strategies, and biologics manufacturing.

Responsibilities

• oversee aseptic processing, environmental and personnel monitoring, cleaning, sterilization, and process validation
• lead investigations of sterility-related events
• assess contamination risks and develop mitigation strategies
• serve as the subject matter expert during inspections, audits, and technology transfers
• develop and review policies and protocols
• provide technical leadership and mentorship within the sterility assurance team

Skills

Leadership

Project management

Regulatory knowledge

Education

Bachelor's degree

Master's degree

Job description

Role

Associate Director of Sterility Quality Assurance at a biopharma site, leading the sterility assurance and contamination control programs to ensure compliance with cGMP, FDA, and global standards.

Responsibilities

• oversee aseptic processing, environmental and personnel monitoring, cleaning, sterilization, and process validation
• lead investigations of sterility-related events
• assess contamination risks and develop mitigation strategies
• serve as the subject matter expert during inspections, audits, and technology transfers
• develop and review policies and protocols
• provide technical leadership and mentorship within the sterility assurance team

Requirements

• Bachelor's degree with 8+ years in microbiology or biological QA, preferably in large molecule sterile manufacturing within an FDA-regulated biotech/pharma environment
• experience with regulatory inspections, contamination control strategies, and biologics manufacturing

Preferred

• Master's degree and extensive knowledge of cGMPs, environmental monitoring, and sterilization validation
• strong technical judgment, communication, project management, and leadership skills
• familiarity with biologics, IND/IMPs, and global regulatory expectations

HighValue

• biologics (large molecules), sterile manufacturing, contamination control, regulatory inspection readiness, and risk assessment

WorkSetup

on-site in Hopewell, NJ; travel approximately 10%