CMC Project Lead

4 weeks ago

South San Francisco, California, United States Centivax Full time
Job Title: CMC Project Lead

About the Role:

We are seeking a highly skilled CMC Project Lead to join our team at Centivax. As a key member of our mRNA vaccine development team, you will be responsible for leading the development and GMP of novel mRNA vaccines and therapeutics.

Key Responsibilities:

* Lead project management for mRNA CMC and supply chain activities to support development, manufacturing, release, and shipments of drug substance and drug product.
* Facilitate planning of regulatory-related CMC activities across drug substance, drug product, and clinical supply chain to align dependencies, schedules, and delivery commitments.
* Create, manage, and facilitate regular meetings, including the development of agendas, issue written minutes, and follow up on action items.
* Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).

Requirements:

* BS or MS in science, pharmaceutical sciences, or related field.
* Minimum 8 years of experience in biologics CMC, and recent direct experience with non-GMP and GMP mRNA manufacturing.
* Strong project management skills.
* Proven track record of critical thinking, flexibility, innovation, including the ability to manage priorities, track progress of key projects, and provide updates to leadership as required.

What We Offer:

* Opportunity to work in a cross-functional, team-oriented organization with individuals from multiple R&D functions and CDMOs in different geographies and countries.
* Direct interaction with R&D external partners and CMO organizations.
* Ability to negotiate and communicate in a positive manner, to discuss and address quality issues, anticipate globally the impact of known risks, and develop effective, pragmatic solutions.

How to Apply:

If you are a motivated and experienced professional looking for a new challenge, please submit your application.

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