Harmit Vora, Ph.D.

CMC Strategy and Execution for Growing Biotechs

Have you ever found your organization accelerating toward an IND or marketing application—only to realize the CMC foundation wasn’t built for the moment? Biotech companies understandably prioritize clinical investment in the early stages, often deferring CMC spend until a strong (pre)clinical signal emerges. The result can be compressed timelines, reactive decision-making, and costly remediation at critical inflection points.

I help small and mid-sized biotech companies anticipate these moments and build integrated, risk-based CMC strategies that align with both development milestones and capital constraints. By focusing on what truly matters—sequencing the right investments at the right time—I help teams reduce technical and regulatory risk, avoid unnecessary spend, and move programs forward with clarity, discipline, and confidence.

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How I Can Help

Strategy & Technical Operations

Program execution strategy and integrated CMC development plans
Lifecycle management and post-approval change strategy
Product control strategy development (DS/DP)
Buy vs. build and network strategy assessments
CDMO/CTO selection and oversight strategy
CapEx planning and manufacturing footprint strategy
Enterprise-aligned innovation and portfolio strategy
Building high-performing technical teams and operating models

CMC Regulatory

Process and analytical change strategy (global filings)
IND/CTA authoring and submission strategy
IND/CTA amendment strategy and authoring
Region-specific regulatory strategies (e.g., US, EU, Japan)
Preparation for regulatory interactions (pre-IND/CTA, EOP, Type C, scientific advice)
BLA/MAA CMC authoring and submission leadership
Module 3/4/5 integration and narrative strategy

Process and Analytical Development

Phase-appropriate drug substance and drug product development frameworks
Upstream and downstream scale-up and process characterization planning
CQA identification and analytical control strategy development
Phase-appropriate method qualification and validation
Technology transfer strategy and execution
PPQ and commercial validation

Recommendations

Harmit is an industry leader in product development and manufacturing and an exceptional collaboration partner. His experience, expertise and professional approach in product formulation, process development, analytical development and manufacturing of gene therapy and biologics pharmaceutical products, combined with his ability to bring teams together and resolve CMC challenges make him a leader in his field. His in-depth knowledge of regulatory strategy, analytical sciences, quality systems, risk management, together with his openness and curiosity make him an exceptional collaboration partner. His contributions to the high priority project on which we collaborated were pivotal to its success. He is extremely personable, smart, creative and fun to work with.

—Mairead Duke, Director, EPEE SERVICES LIMITED (formerly Executive Director, Regulatory Affairs, BioMarin)
Harmit is a strategic and technical CMC leader. He brings thoughtful inquisitiveness and dedicated, solutions-oriented focus to issues at the interface of Clinical Development and CMC. A true partner, Harmit’s strengths lie in his ability to listen, process, and return with ideas and proposals that carefully balance both CMC and Clinical considerations. This was especially evident when we were working together on an AAV gene therapy program from early- through late-stage clinical trials, as we charted a course as colleagues from pre-IND to BLA approval. I give my highest recommendation of Harmit to anyone seeking a collaborative and congenial CMC expert.

—Benjamin Kim, Senior Vice President, Clinical Development, Star Therapeutics
I worked with Harmit for many years at BioMarin. He originally joined our Process Sciences team, and in addition to leading a technical group, transitioned to being the core team representative for Technical Operations for BioMarin's lead gene therapy program. Harmit played a critical role in the successful process and clinical development of Roctavian. He expertly navigated the complex landscape of product comparability, as the process evolved from its clinical to commercial phase. I have always been impressed by Harmit's ability to distill a large body of data into succinct and clear conclusions, and to think strategically about the interplay of clinical and CMC considerations. Having been on the front lines of gene therapy process and product development at a critical period of time, Harmit brings a very unique and experienced perspective to development of complex biological products.

—Victoria Sluzky, Chief Technology Officer, Elektrofi
Harmit is a natural leader and someone I can call a mentor. He had the vision to drive me into research areas that ended up being some of the most significant contributions I made in my career. Harmit was consistently at the forefront of a number of initiatives at BioMarin and he rightfully gained the trust of BioMarin's leadership.

—Daniel Barajas, Senior Scientist, Vectors Innovation, SonoThera

About Me

I am a seasoned CMC product strategy leader with 15+ years of experience across the full drug development lifecycle. I served as CMC lead—from preclinical inception through BLA filing—for one of the first FDA-approved AAV gene therapies. Later, as Head of CMC at BioMarin, I led organization-wide strategy, project execution, and portfolio planning for preclinical and clinical programs spanning small molecules, enzymes, antibodies, and gene therapies.

I have deep experience with regulatory interactions. I have presented to U.S., EU, and Japanese health authorities; authored time-critical regulatory responses; and led integrated Module 3 submissions. I have rebuilt and scaled CMC organizations into high-performing teams, partnered with C-suite executives on strategic, technical, and budget decisions, and managed complex CDMO relationships. I have successfully navigated technical setbacks, regulatory challenges, and program inflection points to advance multiple products through key development phases.

I bring both breadth and depth to CMC strategy, execution, and leadership, helping teams move faster, make better decisions, and reduce risk. My work is driven by a lifelong passion for drug development: growing up in South San Francisco, the birthplace of biotech, I dreamed of contributing to this industry. Personal experiences supporting loved ones with serious illness—including my son, born with an ultra-rare disease—shape my mission: to develop medicines with urgency, rigor, and empathy for the patients and families who are waiting.

Contact

Interested in working together? Fill out some info and I will be in touch shortly. Alternatively, email me directly at harmit@voracmcadvisory.com. I can’t wait to hear from you!