Kinkini Roy
◾Biotech CMC & Drug Delivery Leader ◾ Formulation, Process Development, Tech Transfer & Clinical Supply ◾ Nanomedicine, ◾ Translating Science into Scalable Therapies ◾Polymer, Material Sc◾ Injectable, Prefilled Syringe
- Role
- Associate Director, Drug Product Development at Aviceda Therapeutics
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Kinkini Roy
Seasoned biotechnology leader with over a decade of experience driving product development, drug delivery innovation, and CMC strategy across pharmaceutical, biotechnology, and medical device organizations. Proven track record of translating scientific concepts into scalable technologies and advancing complex therapeutics from discovery through clinical development. Extensive experience leading cross-functional teams spanning R&D, manufacturing, regulatory, and commercial functions to deliver high-impact programs in fast-paced biotech environments. Recognized for building and guiding interdisciplinary teams to solve complex technical challenges, optimize product performance, and enable successful technology transfer and clinical supply. Deep expertise in advanced drug delivery systems, formulation development, and process scale-up, with experience supporting regulatory submissions and interacting with global health authorities. Adept at integrating strategic, technical, and operational perspectives to align development activities with broader business and clinical objectives. A strategic and influential leader known for combining strong scientific insight with practical engineering and manufacturing solutions. Highly organized and results-driven, with the ability to prioritize competing initiatives while maintaining rigorous quality and regulatory standards. Passionate about transforming innovative science into clinically meaningful therapies that improve patient outcomes.
Experience
Associate Director, Drug Product Development
May 2023 — Present · Cambridge, MA, US
Provide technical and strategic leadership for drug product formulation, process development, and CMC strategy supporting next-generation therapeutic platforms targeting inflammatory and immunological diseases.Lead cross-functional teams advancing complex drug delivery technologies from early research through clinical development, aligning R&D, CMC, regulatory, and manufacturing strategies.Develop scalable formulation and manufacturing processes and oversee technology transfer to CDMOs to ensure reliable clinical supply and manufacturing readiness.Apply Quality by Design (QbD), Design of Experiments (DoE), and risk-based development frameworks to establish critical process parameters, optimize product performance, and support scale-up.Build and manage strategic collaborations with CDMOs, CROs, academic institutions, and technology partners to expand technical capabilities and accelerate development timelines.Contribute to CMC regulatory strategy and documentation, including IND-enabling sections related to drug product development and manufacturing processes.Lead multidisciplinary technical investigations and root cause analyses to address complex development challenges and guide formulation and process optimization. Hired & managed effective team of scientists and managers
Education
The University of Southern Mississippi
Graduate Research Assistant, Biochemistry
2004 — 2007
Harvard Business School
Diploma in Specialization in Leadership & Management
2021 — 2022
University of South Carolina
PhD, Polymer, Organic, Nanomaterial & Supramolecular Chemistry
University of Calcutta
MS, Biotechnology
2001 — 2003
University of Massachusetts Amherst
Post Doc Fellow, Polymer Science & Enginnering
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