Shahram Katousian
- Role
- Vice President, Head of Cmc at Engene
- Location
- Rancho Santa Fe, CA, US
- LinkedIn followers
- 500 followers
About Shahram Katousian
Professional Summary: Strategic and operational leader with over 20 years of…
Experience
Vice President, Head of Cmc
Apr 2023 — Present
Responsible for overall manufacturing strategy for enGene pipeline products in various development stages ranging from lead optimization and preclinical GLP studies through global late-phase clinical trials and registration pivotal studies and commercial launch. Provide strategic leadership in planning and execution of BLA enabling CMC activities for late-phase clinical trials including management of cross-functional teams and CDMO partners and suppliers, including contract negotiations and clinical/commercial supply agreements. Perform on-site visits as needed to key suppliers in North America, Asia, and Europe to maintain strong relationships with all external and internal stakeholders, including corporate partners, to ensure performance targets are met or exceeded. Ensure all process development, cGMP manufacturing, analytical method and process validation activities are completed in accordance with global regulatory requirements to support global regulatory submissions. Actively participate in regulatory meetings, identify gaps, and proactively provide risk mitigation strategies for regulatory submissions required for clinical trial and marketing applications. Participate in and represent CMC function in meetings with global regulatory agencies. Discuss and present CMC information and manufacturing plans/updates to the Executive team, Board of Directors, and corporate partners.
Skills
- Fda
- Microbiology
- Cell
- Biochemistry
- Regulatory Affairs
- Protein Chemistry
- Processes Development
- Clinical Development
- Pharmaceutics
- Formulation
- Clinical Trials
- Organic Synthesis
- Immunology
- Glp
- Bioreactor
- Technology Transfer
- Biotechnology
- V
- Uv/Vis
- Management of Direct Reports
- Protein Purification
- R
- Pharmaceutical Industry
- Chemistry
- Molecular Biology
- Pharmacology
- Medical Devices
- Lims
- Regulatory Submissions
- Sop
- Vaccines
- Project Management
- Cell Culture
- Lc-Ms
- CRO
- Oncology
- Purification
- Drug Discovery
- Validation
- Assay Development
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