Yashas Rajendra
Director | CHO CLD & USP | Tech Transfer | PC/PV | IND/BLA
- Role
- Director & Principal Scientist at Denali Therapeutics
- Location
- San Mateo, CA, US
- LinkedIn followers
- 500 followers
About Yashas Rajendra
Director-level CLD and USP leader with experience spanning large pharma and high-growth biotech. I lead CLD/USP strategy for complex biologics from early development through late-stage readiness, balancing speed, manufacturability, and regulatory risk while building high-performing teams and strong technical capabilities. I partner closely with CDMOs, Internal Manufacturing and CMC stakeholders to support tech transfers, define process characterization plans, and establish strategies that support GMP manufacturing and regulatory submissions. Focus areas: CHO CLD, upstream process development, complex modalities (multi-chain/bispecifics, enzyme fusions), process characterization/validation, CDMO oversight, and CMC documentation support.
Experience
Director & Principal Scientist
Aug 2024 — Present · South San Francisco, CA, US
Provide strategic and technical leadership for cell line development (CLD) and upstream process development (USP) to advance complex biologics from early to late-stage development and commercialization.2. Set CLD and USP strategy across multiple programs, balancing speed, manufacturability, and regulatory risk3. Guiding BLA-enabling studies and supporting regulatory submissions for late stage programs4. Mentor and grow a team of scientists and managers, fostering excellence in innovation, execution, and scientific rigor.
Education
KTH Royal Institute of Technology
M.S, Molecular Biotechnology
2006 — 2008
Visvesvaraya Technological University
B.E, Biotechnology
2002 — 2006
EPFL
PhD, Biotechnology
2009 — 2012
Skills
- Fortebio Octet
- Dna
- Cell Culture
- Protein Expression
- Transient Transfection
- Flow Cytometry
- Elisa
- Cell
- Process Development
- Stirred Tank Reactor
- Cell Biology
- Bacterial Culture
- Fluorescence Spectroscopy
- Western Blotting
- Transfection
- Mammalian Cell Culture
- Sds-Page
- Electrophoresis
- Molecular Cloning
- Qpcr
- Bioreactor
- Orbially Shaken Bioreactors
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