Professional Overview
Abizer Harianawala is a seasoned pharmaceutical executive with over 15 years of experience in CMC (Chemistry, Manufacturing, and Controls) and technical operations. He currently serves as the Vice President of CMC & Technical Operations at Alkeus Pharmaceuticals, Inc., where he oversees the development and implementation of robust manufacturing and supply chain strategies to support the company's pipeline of novel therapeutics.
Experience Summary
Current Role
As Vice President of CMC & Technical Operations at Alkeus Pharmaceuticals, Abizer is responsible for leading all aspects of the company's CMC and technical operations functions. He is instrumental in driving the successful scale-up and commercialization of Alkeus' lead product candidate, leveraging his deep expertise in pharmaceutical development and manufacturing. Under his leadership, the CMC team has achieved key milestones, including the completion of a successful IND-enabling GMP campaign and the initiation of Phase 2 clinical trials.
Career Progression
Prior to joining Alkeus, Abizer held several senior leadership roles in the pharmaceutical industry. Most recently, he served as the Vice President of CMC at Cyteir Therapeutics, where he led the CMC strategy and implementation for the company's novel oncology therapeutics. Before that, he was the Executive Director and Head of CMC at Cyteir, driving the successful advancement of the company's pipeline from early-stage development to late-stage clinical trials.
Abizer's career also includes roles at Stevanato Group, where he was the R&D Technology and Site Leader for the company's US Technology Excellence Center, and at TARIS Biomedical (acquired by Johnson & Johnson) and ARIAD Pharmaceuticals (acquired by Takeda), where he held positions of increasing responsibility in product development and technical operations.
Academic Background
Abizer holds a Bachelor's degree in Chemical Engineering from the University of Michigan and a Master's degree in Chemical Engineering from the University of Massachusetts Lowell.
Areas of Expertise
- Pharmaceutical development and manufacturing
- CMC strategy and implementation
- Technical operations and supply chain management
- Process development and scale-up
- Quality assurance and regulatory compliance
- Cross-functional team leadership and collaboration
Professional Impact
Throughout his career, Abizer has demonstrated a track record of successfully navigating complex technical and operational challenges to advance pharmaceutical programs from early development to commercialization. His ability to build and lead high-performing teams, coupled with his deep technical expertise, has consistently led to the timely and cost-effective delivery of critical CMC and operational milestones.
Conclusion
With his extensive experience in the pharmaceutical industry and proven leadership in CMC and technical operations, Abizer Harianawala is well-positioned to drive the continued growth and success of Alkeus Pharmaceuticals as it advances its pipeline of transformative therapies.