Pallavi Gambhire
Analytical Development | Director | Cell and Gene Therapy | CMC Strategy & Regulatory Alignment | Cross-Functional Biotech Leader
- Role
- Associate Director, Analytical Development at Editas Medicine
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Pallavi Gambhire
I specialize in Analytical Development and CMC strategy, currently working as an Associate Director at Editas Medicine. My strength lies in translating complex science into decisions that navigate and accelerate development while reducing risk. I\'ve built analytical frameworks that has enabled IND submissions, managed external CDMOs and CROs and partnered with Regulatory, Quality and Process Development to ensure implementation of phase appropriate control strategies.Whether I am guiding a team through resource and time constrained development plans or navigating shifting program priorities, I lead with rigor, transparency and a strong sense of purpose.I am especially passionate about evolving into a new role where I can shape CMC strategy at the program or portfolio level and contribute to bringing life-changing, safe and efficacious therapies to patients faster.I am always open to connecting with other leaders in the biotech ecosystem to share ideas, collaborate and discuss opportunities to grow.[CMC Strategy, IND, Analytical Development, Regulatory Interactions, Tech Transfer, Biologics, Cell and Gene Therapy, mRNA, LNP, CDMO management, Stability, Specifications, GMP]
Experience
Associate Director, Analytical Development
Nov 2023 — Present · Cambridge, MA, US
Developing phase appropriate and risk based analytical strategy, including biophysical method establishment for clinical batch release and characterization of gene editing components and drug product (DP).Authored regulatory document content (eCTD) for various IND, preIND, CTA, IND-A, Type B, C, D submissions and meetings as well as organized responses to regulatory agency questions (FDA and Health Canada) that led to successful agency interactions and IND filings.
Education
Northeastern University
Master of Science (MS), Pharmaceutical Sciences
Osmania University
B.Pharm, Pharmaceutical Sciences
Little Flower Junior College
High school, Mathematics; Physics; Chemistry
1999 — 2001
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.