Remote Senior Manager, CMC Technical Operations (Vaccine)

Sabin Vaccine Institute, Inc.; Northern (KY); Hybrid; USD 135,000 - 165,000; Full time

Job summary

Sabin Vaccine Institute, Inc. in the United States is seeking a Senior Manager, CMC Technical Operations to drive end-to-end CMC activities from development through regulatory readiness.

You will partner with the CMC Product Champion and external partners to align manufacturing, analytics, and quality across Sabin’s vaccine programs. The role demands strong project leadership in a matrix environment, deep CMC expertise, and the ability to travel up to 15%.

Qualifications

• Bachelor's degree in biochemical engineering, analytical chemistry, pharmaceutical sciences, biochemistry, or related field.
• 10+ years of direct experience with CMC product and process development.
• Direct experience with CMC biotechnology product and process development.
• Knowledge of cell line development, drug substance/product, analytics, stability programs, and specifications.
• Understanding of regulatory guidelines (FDA, EMEA, MHRA) and ICH guidelines.
• Strong project management, problem solving and interpersonal skills.
• Experience with cGMP.
• Willingness to travel up to 15% domestically and internationally.
• Interest in Sabin’s mission.

Responsibilities

• Serve as cross-functional matrix team member and support end-to-end integration of CMC efforts.
• Collaborate with internal and external CMC areas to ensure timely, on-budget results.
• Assist with development and manufacturing alliance management and strategy.
• Provide expert technical guidance across all CMC elements.
• Facilitate communication between Sabin and external partners.
• Identify risks and work with teams to mitigate.
• Support authoring and data verification of Module 3 IND, BLA/MAA submissions.
• Collect information to support future funding.
• Manage, create and review CMC and Quality Systems documentation.
• Support governance, resourcing, and financial planning activities.
• Provide updates and presentations to stakeholders.

Skills

Project management

Writing & presentation

Matrix leadership

Independent work

Stakeholder communication

Problem solving

Education

Bachelor's degree in biochemical engineering/analytical chemistry/pharmaceutical sciences/biochemistry or related field

Advanced degree desired

Job description

Sabin Vaccine Institute, Inc. in the United States is seeking a Senior Manager, CMC Technical Operations to drive end-to-end CMC activities from development through regulatory readiness.

You will partner with the CMC Product Champion and external partners to align manufacturing, analytics, and quality across Sabin’s vaccine programs. The role demands strong project leadership in a matrix environment, deep CMC expertise, and the ability to travel up to 15%.