Senior Director Upstream and Downstream Process Development

Our Mission

At BioNTech, we are committed to translating cutting-edge science into transformative therapies for patients worldwide. As we continue to advance our immunotherapy portfolio, we are seeking an experienced and visionary leader to drive process development strategies for our immunomodulator programs across clinical and commercial stages.

Your Responsibilities

As Senior Director, Upstream & Downstream Process Development, you will provide scientific and organizational leadership for the development of robust, scalable, and compliant manufacturing processes supporting innovative biologics in preclinical and clinical stage.

You will:

Lead upstream and downstream process development activities including recombinant proteins, cytokines, fusion proteins, and other novel biologics.

Lead Pre-Tox and phase I materials manufacturing. Drive process optimization to improve product quality, manufacturing robustness, yield, and cost efficiency.

Define and establish Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), and control strategies in alignment with Quality by Design (QbD) principles.

Lead process characterization, validation, and lifecycle management activities to ensure manufacturing consistency and regulatory compliance.

Oversee technology transfer from development into GMP manufacturing facilities and support scale-up initiatives across global manufacturing networks.

Collaborate with the GTD team for all the innovation projects. Partner closely with Manufacturing, MSAT, Analytical Development, Quality, Regulatory Affairs, and Supply Chain teams to deliver key program milestones.

Contribute to global regulatory submissions, inspections, and health authority interactions.Build, mentor, and develop a high -performing team while fostering a collaborative and innovative working environment.

Who you are

> 15 years of master's or > 10 years of Ph. D. in Biologics development;

Extensive experience within biopharmaceutical process development and manufacturing.Hands-on experiences of biologics manufacturing processes, upstream (Preferred) or downstream.

Demonstrated success in process scale-up, technology transfer, GMP manufacturing support, and late-stage development programs

Familiar with the IND submission regulation for process development and manufacturing for the US/China;

Strong stakeholder management skills and ability to build effective partnerships across local, global functions internally and externally