Senior Manager, Manufacturing Operations - Remote

Overview

Rezolute is seeking a seasoned professional to support its late-stage and commercial external manufacturing operations. The Senior Manager of Manufacturing Operations will be a proactive, independent leader with a strong understanding of the interface between Pharmaceutical Manufacturing and Quality Assurance.

In Short

• Responsible for the manufacture of Drug Substance (DS) and Drug Product (DP).
• Acts as technical and business lead where applicable.
• Liaises with Internal SMEs to ensure coordination with the plan of record.
• Leads Internal Manufacturing Operations Alignment Meetings.
• Develops facility fit assessments for Technology Transfers.
• Acts as person-in-plant during tech transfer and clinical manufacturing.
• Ensures Master Batch Records are finalized prior to cGMP manufacturing.
• Authors and reviews technical reports.
• Participates in the generation of integrated Global Supply plans.
• Identifies and resolves issues proactively and independently.

Requirements

• Bachelor's degree in scientific/technical discipline.
• 8 years of relevant experience, preferably in biopharmaceuticals.
• Experience in manufacturing operations management in life sciences.
• Understanding of biologics cGMP requirements.
• Ability to work independently in a remote-work environment.
• Strong project management and risk management skills.
• Excellent interpersonal skills for cross-functional collaboration.
• Proficient in Microsoft Teams, Excel, Word, and PowerPoint.

Benefits

• Opportunity to work in a fast-paced and impactful environment.
• Collaboration with a diverse team of professionals.
• Engagement in innovative drug development.
• Potential for career growth and development.