Michael Zakrewsky
- Role
- Associate Director Next-gen Manufacturing and Drug Delivery at Johnson & Johnson
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Michael Zakrewsky
Builds and leads highly efficient R&D teams that apply combined knowledge to generate new…
Experience
Associate Director Next-gen Manufacturing and Drug Delivery
Dec 2021 — Present
Accountable for developing formulations and processes for the manufacture of biologics drug products including cell therapies, antibodies, gene therapies, oligonucleotides, and chemical- and radio-conjugates, through commercial launch. Owns the design and implementation of process validation plans and leads teams to successfully execute tech transfer, scale-up, and commercial validation activities for frozen, liquid, lyophilized, and other novel formulated drug products. Proven leader of large (>25), multi-level reporting lines and highly cross-functional, matrixed CMC teams. Manages department’s ~$45M innovation budget. Responsible for strategy and execution of internal/external initiatives focusing on novel formulation and drug delivery technologies. Experienced subject matter expert of frozen, dried, and ultra-high-concentration formulation and process development. Integrated formulation and process development workflows to enable data-driven, risk-based decision making, speed to clinic, and reduce material and resource requirements for successful tech transfers. Executed successful tech transfers of over 13 clinical drug products and 4 commercial drug products across 5 different internal and external manufacturing sites. Spearheaded streamlined process qualification approaches (matrixed, bracketed, and integrated clinical/PPQ batch process qualifications). Directly resulted in 50% reduction in number of batches required for BLA/MAA. Championed development and implementation of PAT technologies to enable real-time data collection, robust control strategies, and reduced manufacturing costs. Led design and implementation of digital twin and first-principles models to enable flexible regulatory filing and efficient lifecycle management (scale-ups, scale-outs, multi-generational drug products). Collaborated with functional stakeholders to ensure Right-First-Time formulations, processes, and site selections. Authored INDs, IMPDs, BLAs, and MAAs.
Education
Rensselaer Polytechnic Institute
Bachelor of Science (BS), Chemical and Biomolecular Engineering
UC Santa Barbara
Certificate in Management Practices, Technology Management
The Wharton School
Certificate in Executive Influence, Organizational Leadership
UC Santa Barbara
Doctor of Philosophy (PhD), Chemical Engineering
Skills
- Protein Chemistry
- Uv/Vis
- Microscopy
- Scanning Electron Microscopy
- In Vivo
- Spectroscopy
- Confocal Microscopy
- Process Simulation
- Cell
- Characterization
- Drug Delivery
- Cell Biology
- Research
- Uv/Vis Spectroscopy
- Cell Culture
- Purification
- Afm
- Fluorescence Microscopy
- Nanotechnology
- Laboratory Skills
- Science
- Biotechnology
- Laboratory
- Mathematica
- Biochemistry
- Matlab
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