Manager/Senior Manager, Drug Product CMC - Remote

Overview

The Manager/Senior Manager, Drug Product CMC provides comprehensive technical support and expertise in Chemistry, Manufacturing, and Controls (CMC), particularly focusing on the tech transfer and onboarding of new drug product and associated long-term storage and labeling facilities in the United States.

In Short

• Lead tech transfer and onboarding of new US-based Drug Product site for biopharmaceutical vaccines.
• Oversee day-to-day management of new Drug Product site.
• Provide technical leadership in aseptic drug product manufacturing.
• Review and author vaccine candidate INDs and regulatory submissions.
• Support process characterization for late-stage vaccine candidates.
• Prepare documentation for future funding efforts.
• Manage CMC and Quality Systems documentation.
• Develop validation and commercialization strategies for Drug Products.
• Implement contingency plans for Drug Product supply chain.
• Support management of third-party storage and logistics in the USA.

Requirements

• Bachelor’s degree in chemical or pharmaceutical engineering, chemistry, or related field; advanced degree preferred.
• 7+ years of experience with CMC in biopharmaceutical manufacturing.
• Experience with cGMP and regulatory guidelines.
• Ability to work independently and collaboratively.
• Willingness to travel up to 25% within the USA.

Benefits

• Competitive salary range of $95,000 - $137,000.
• Medical, Dental, Vision, and Flexible Spending Accounts.
• Employer paid Life and Disability insurance.
• 11 paid holidays and a winter break.
• Employer match on 401(k).