Senior Manager of Technical Operations - Remote

Overview

The Senior Manager of Technical Operations is responsible for overseeing the manufacture of commercial drug products at Contract Manufacturing Organizations (CMOs), ensuring adherence to project timelines and maintaining relationships with CMOs.

In Short

• Lead and oversee drug product manufacturing at CMOs.
• Review and oversee documentation related to production.
• Coordinate batch release processes and ensure timely documentation review.
• Support scale-up and process validation at CMO sites.
• Provide technical support and regulatory CMC activities.
• Collaborate with Pharmaceutical Sciences for experimental assessments.
• Track CMO KPIs for process improvements.
• Investigate complaints and review data for improvements.
• Support due diligence assessments for business opportunities.
• Manage project budgets effectively.

Requirements

• B.S./M.S./Ph.D. in relevant fields.
• 12+ years of engineering experience in pharmaceutical development.
• Strong understanding of scale-up, validation, and technology transfer.
• Knowledge of cGMP, FDA, EU, ICH guidelines.
• Experience with aseptic manufacturing techniques.
• Problem-solving and decision-making abilities.
• Exceptional organizational skills and attention to detail.
• Project management and Lean Six Sigma certifications preferred.
• Experience in drug product manufacturing processes.
• Strong communication and collaboration skills.

Benefits

• Health, dental, and vision insurance benefits.
• Generous paid time off including vacation and personal days.
• Bonus and stock equity opportunities.
• Work-life balance initiatives.
• Supportive company culture focused on patient commitment and innovation.