Senior Director Upstream and Downstream Process Development (Zhuhai, GD, CN, 519080)
About this opportunity
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
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Job details
How this role compares
Computed from every other active Manufacturing & CMC role in our database, not just this employer's listings.
We currently track 179 comparable Senior Director Manufacturing & CMC roles across 48 biopharma companies.
Salary context
90 of 179 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 179 comparable roles
+ 10 more countries
Seniority mix
179 of 179 peers have a known seniority level
Therapeutic area mix
4 of 179 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.