Robert Damitz
Formulation and Product Development, Gene Therapy at Kriya Therapeutics
- Role
- Director, Formulation Development at Kriya Therapeutics, Inc.
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Robert Damitz
I am passionate about improving patients\' lives & addressing unmet medical needs with groundbreaking pharmaceutical therapies. I am an enthusiastic and versatile scientific leader offering a holistic focus on product quality and patient safety to CMC development. I have diverse formulation and process development experience from roles in cell & gene therapy and small molecule specialty dosage forms. I am well-versed in analytical techniques, regulatory environments and cGMPs. I have held roles as both the CMO and the client, and I value good working relationships between parties. I have excellent technical communication skills and am adept at condensing complex topics to be easily understood. I enjoy mentoring, educating, and building teams for success.
Experience
Director, Formulation Development
Oct 2023 — Present · Raleigh-Durham-Chapel Hill, NC, US
Built high-performing formulation development group at gene therapy startup. Hired and trained top talent. Implemented novel analytical techniques to improve product stability. Planned and managed budgets and development timelines to meet company goals and objectives. Owned formulation, drug product, and administration device topics on CMC teams advancing numerous assets from candidate selection to IND/CTA & FPI readiness. Developed & implemented systematic formulation development approach to identify highly stable formulations for multiple viral vector (AAV) serotypes. Supported stability-indicating analytical method assessments by designing and executing robust forced degradation studies. Established in-use stability for all pipeline candidates while optimizing clinical and commercial product presentations. Published findings at top cell & gene therapy conferences with numerous submissions selected for oral presentations.
Education
University of Florida
Ph.D., Chemical Engineering
University of Michigan
B.S. Engineering, Chemical Engineering
Skills
- Technical Communication
- Liposomes
- Data Analysis
- Pharmaceutics
- Programming
- Light Scattering
- Pharmacokinetics
- Project Management
- Guitar
- Technical Leadership
- Pk/Pd
- Analytical Chemistry
- Mathematical Modeling
- Aseptic Technique
- Matlab
- Research Project Management
- Bacterial Cell Culture
- Process Engineering
- Research and Development (R&D)
- Cello
- Regulatory Submissions
- Emulsions
- Nmr Spectroscopy
- Preformulation
- Dissolution
- Uv/Vis
- Gc-Ms
- Chromatography
- Python
- Engineering
- Cgmp
- Research
- Formulation
- Chemical Engineering
- Colloids
- Drug Delivery
- Statistical Data Analysis
- Adme
- Human Physiology
- Design of Experiments
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