Ashwin Raghavan Email & Phone Number

Canton, Massachusetts, US

US

• Represented CMC in cross-functional activities internally and externally for two worldwide clinical stage programs (small molecule; Phase I and Phase II pivotal)
• Designed cross-functional tools to facilitate on-time delivery of clinical supplies to clinical sites with multiple IND/IMPD and clinical protocol changes.
• Planned timelines, strategy, and budgets for technology transfers, scale-up and validation plans for API and Drug Product in preparation for NDA filing and commercialization.
• Provided high-level dashboards and risk assessments to senior leadership for strategic discussions.

San Diego, California, US

• Planned and executed the development/technology transfer & scale-up of allogeneic cell therapy products for Phase I/II clinical trials at client site
• Advised on strategy effectiveness of client decisions and built risk mitigation solutions
• Exceeded timeline deliverables with a combination of Agile & waterfall development strategies.
• Instituted improved client processes for product development, communication, effective decision making and operations leading to better successful batch outcomes.
• Responsibly led and mentored a team of project managers using short-term and long-term goals for their professional growth and client satisfaction.
• Developed a Project Management focused training program for beginner and experienced project management professionals.

San Diego, California, US

• Planned and executed the technology transfer/scale-up of two oral solid products for Phase II and III clinical trials
• Built and managed the project timeline to meet aggressive target dates
• Rallied alliances with CDMOs, CROs and internal resources to achieve a viable Phase II and III product
• Effectively communicated solutions and conducted risk mitigation strategies to reduce the failure modes.

• Communicated project plans and progress to key stakeholders, including project contributors, business, operational and technical resources.
• Orchestrated projects within strict timeframes and budget constraints by solving complex problems and working closely with senior leaders.
• Vetted potential contract contributors (e.g. Contract Manufacturers or Laboratories) to meet client's project goals.
• Developed relationships with contributors to supply chain such as vendors, manufacturers, contract laboratories etc.
• Prepared and edited RFPs, Proposals, technical documents and partnership documents including but not limited to: regulatory documents for ANDA, NDA, Medical Devices, partnership contracts etc.

Bridgewater, New Jersey, US

• Led team efforts of 5-8 members in formulation development, technology transfers, stability data interpretation and commercial planning.
• Developed timelines, budgets, FTE requirements and training programs for fast program execution and team development.
• Identified critical paths to project success through use of cross functional discussions and software analysis.
• Strategized about regulatory pathways and heavily involved in ANDA Documentation Writing and Review process.
• Implemented new processes and software to streamline document flow, project management efforts and improve overall communication efforts in a startup environment.

Bridgewater, New Jersey, US

• Conducted formulation development, technology transfers and FDA-related response efforts along with team members.
• Led reverse-engineering activities for Q1/Q2 bio-waivers, analytical method development and validation of Assay, Related Compounds and Alcohol methods
• Formulated robust products for ANDA filings through Design of Experiments and Scale-Up Activities for topical Rx semi-solids, solutions and foam products.
• Performed extensive ANDA Documentation writing and review for regulatory submissions.
• Took on responsibility for Project Leadership, team management, mentoring experience through hands-on training and process streamlining in a startup environment.

Washington, New Jersey, US

• Performed study design, execution and report write-ups for formulation and analytical development efforts for different clients.
• Participated in regulatory discussions with clients to ensure proper strategy for development including conducting background literature searches on Products through Patent landscaping, FDA guidance review etc.
• Developed and validated in-vitro Release and Permeation testing via Franz-type Diffusion systems for both bio-waiver and clinical based products.
• Formulated robust products by understanding Quality Target Product Profiles and using Design of Experiments (DoE) methodology to mitigate Product risks.
• Performed Technology Transfer experience in both analytical methods for validation and formulation process for scale-up of ointments, creams, and solutions.

Master Of Science - Ms, Innovation And Entrepreneurship

Master Of Business Administration - Mba

Bachelor Of Arts - Ba, Biology/Biological Sciences, General