Hema Vadlapudi
MSAT Manager @ KBI Biopharma
- Role
- Manager, Msat and Process Engineering at KBI Biopharma
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Hema Vadlapudi
As MSAT Manager, I lead Technology Transfer initiatives, enabling the integration of products into large-scale facilities while conducting comprehensive risk assessments and validations to uphold stringent quality standards. Collaborate with various departments in critical deviation investigations and process enhancements, acting as a subject matter expert for downstream processes.Throughout my career, I\'ve demonstrated a collaborative approach to advancing pharmaceutical manufacturing while leveraging expertise in process optimization, compliance, and strategic leadership. I strive for operational excellence, continually elevating industry standards and driving collective success.
Experience
Manager, Msat and Process Engineering
Jul 2024 — Present · Raleigh-Durham-Chapel Hill, NC, US
Lead downstream process engineering and tech transfer team focusing on employee growth and career advancement.• Oversee tech transfer process for new product introductions by guiding project leads in facility fit assessments and equipment selection, defining scope and supporting systems through user requirements, design, build, commissioning, qualification, validation, and subsequent operation.• Manage introduction of new commercial products and develop process characterization and PPQ strategies from Stage 2 PPQ through Stage 3 CPV Process Validation and Pre-Approval Inspection (PAI).• Implement campaign analysis for the manufacturing of clinical and commercial GMP drug substances throughout the product lifecycle utilizing Manufacturing Execution Systems and electronic batch release.• Collaborate with CDMO clients to provide technical oversight in the development and implementation of strategies associated Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).
Education
North Carolina State University
Master's degree, Chemical Engineering
Birla Institute of Technology and Science, Pilani
Bachelor's degree, Chemical Engineering
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