Senior Manager, Quality CMC (Chemistry, Manufacturing, and Controls) - Remote

Overview

The Senior Manager, Quality (CMC) provides comprehensive technical support and expertise in Chemistry, Manufacturing, and Controls (CMC) for the quality unit, particularly focusing on the transfer and onboarding of new aseptic finish/fill drug product sites in the United States.

In Short

• Quality lead and support for technical transfer and onboarding of new drug product Fill/Finish sites.
• Provide quality leadership in areas of expertise including cell line development and drug product manufacturing.
• Assess and evaluate GXP service providers for regulatory compliance.
• Participate in internal and external audits/inspections.
• Assist in development and implementation of quality systems.
• Manage, create, and review CMC SOPs and documentation.
• Support vaccine drug development activities.
• Promote a quality culture within the organization.
• Work independently with minimal oversight.
• Travel domestically and internationally as needed.

Requirements

• Bachelor’s degree in a scientific field; master’s degree a plus.
• 9+ years of relevant experience in GXP quality assurance/quality control roles.
• Strong knowledge of vaccine development preferred.
• Demonstrated competence with computerized systems and Microsoft Office.
• Excellent communication and interpersonal skills.
• Experience in project execution using virtual platforms.
• Strong attention to detail and organizational skills.
• Ability to work in a collaborative team environment.
• Ability to travel as required.
• Ability to work independently.

Benefits

• Competitive salary range of $115,000 - $145,000.
• Medical, Dental, Vision, and Flexible Spending Accounts.
• Employer paid Life and Disability insurance.
• 11 paid holidays with a winter break.
• Employer match on 401(k).