Senior Biopharma Validation Lead: Process & Cleaning

Scorpion Therapeutics; Durham (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics seeks a senior process and cleaning validation lead to manage programs for biopharmaceutical manufacturing during early-stage development. You will develop validation master plans, protocols, and reports; conduct risk assessments and gap analyses; evaluate equipment and procedures; support regulatory submissions and inspection readiness; train personnel; and oversee a 3–5 person validation team including contractors.

Travel up to 25% is expected.

Qualifications

• Bachelor's degree in Engineering, Chemistry, or related field required.
• 8+ years in biopharma manufacturing validation.
• Strong project management and technical documentation skills.
• Leadership experience with 3–5 person team preferred.

Responsibilities

• Develop validation master plans, protocols, and reports.
• Conduct risk assessments and gap analyses.
• Evaluate equipment and process procedures as part of validation.
• Support regulatory submissions and inspection readiness; train personnel and oversee contractors.

Skills

Project management

Technical documentation

Team leadership

Validation knowledge

Risk assessment

Gap analysis

Training

Education

Bachelor's degree in Engineering, Chemistry, or related field

Tools

Smartsheets

Job description

Scorpion Therapeutics seeks a senior process and cleaning validation lead to manage programs for biopharmaceutical manufacturing during early-stage development. You will develop validation master plans, protocols, and reports; conduct risk assessments and gap analyses; evaluate equipment and procedures; support regulatory submissions and inspection readiness; train personnel; and oversee a 3–5 person validation team including contractors.

Travel up to 25% is expected.