Product Technical Operations Scientist

About the role

Venesco LLC is seeking Product Technical Operations Scientists to provide Chemistry, Manufacturing and Controls (CMC), investigational product, manufacturing, quality, and nonclinical support across the medical product lifecycle to facilitate successful product development and regulatory approvals.

Responsibilities

• Support manufacturing strategy development.
• Review product specifications and manufacturing records.
• Support investigational product accountability and logistics.
• Review analytical and bioanalytical validation activities.
• Participate in manufacturing audits and inspections.
• Review stability programs and quality documentation.
• Support CMC content for regulatory submissions.
• Evaluate manufacturing risks and quality deviations.
• Support nonclinical study review activities.
• Participate in integrated product teams.

Requirements

• Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related field.
• Minimum 5 years of CMC or pharmaceutical development experience.
• Knowledge of FDA regulatory requirements, GMP, and GLP.
• Experience supporting regulated product development.

Pay

$135,000 - 150,000