Program Management Gene Therapy

GOWRI RAGHUNANDAN, M.S., PMP

732-***-**** ****************@*****.*** LinkedIn

PROFILE

• Expertise in CMC and Program Management for large and small molecule drugs with 10+ years of professional experience

• Experience in gene therapy AAV manufacturing using HEK293 adherent and Sf9 baculovirus platforms

• Extensive knowledge and experience in clinical drug development (BLA and NDA paths) and clinical manufacturing

• Effectively collaborated cross-functionally with Pre-clinical, Regulatory, Quality and Clinical to facilitate project delivery

• Proven leadership in managing external CDMOs to support IND-enabling preclinical studies and GMP clinical studies

• Led a start-up gene therapy biotechnology company from Discovery through multiple IND approvals, IPO and M&A

• Experience with implementing CMC strategies based on FDA/EMA guidance in Neurodegenerative and Pain diseases

• Leader for technical teams in various departments including CMC, Technical Operations, R&D, Quality and Regulatory RELEVANT WORK EXPERIENCE

Double Rainbow Biosciences Inc., Lexington, MA Oct 2021-May 2023 Director of CMC/Program Management

• Developed and monitored detailed CMC plan, budget and timelines for lead compounds, presented risks and provided mitigations reporting directly to C-Suite

• Drove the company’s CMC development plans by providing program management and technical guidance on manufacturing, scale-up, technology transfer, DS/DP stability programs, batch record review and material release

• Effectively communicated in cross-functional program team meetings, representing the CMC department

• Accomplished the company’s key clinical strategies and delivered GMP material, enabling a first in-human study

• Managed external CDMOs for small molecule GMP drug substance (DS) and drug product (DP) manufacturing processes

• Headed the CDMO selection process, prepared RFPs, compared and evaluated criteria resulting in signing on a new CDMO for fill/finish activities

Prevail Therapeutics, A wholly-owned subsidiary of Eli Lilly and Company, New York City, NY Jan 2019-Sep 2021 Director, CMC Program Management (Dec 2020-Sep 2021)

• Interfaced with CDMO to review progress of project tasks, resulting in GMP material delivery for multiple clinical trials

• Led CMC team meetings to drive key decisions with stakeholders – Created agendas, meeting minutes and action items

• Ensured successful technology transfer and worked with CDMO to reduce COGM by implementing process improvements

• Maintained and updated the CMC dashboards and represented the CMC team in cross-functional program team meetings

• Implemented RACI matrix for the CMC team and identified roles each member would hold throughout the project

• Maintained accurate project data via Gantt charts, reviewed critical path activities, identified risks and provided mitigations Associate Director, CMC Program Management (Jan 2019-Dec 2020)

• Led the team through pipeline program build-up, resulting in multiple IND and IMPD regulatory approvals – Managed cross-functional team IND writing for Modules M1-M5

• Reviewed and monitored project delivery against the external manufacturing CDMO statement of work (SOW)

• Provided portfolio deck updates for board meetings on CMC team progress against milestones

• Developed CMC budget, timelines, strategies and monitored deliverables for several programs through clinical phases

• Ensured project schedules and risk management plans (FMEA) were fully developed

• Collaborated with Business Development to develop long-term CMC strategies ensuring alignment with corporate goals Reliance Vitamin LLC., Edison, NJ May 2015-Nov 2018 Senior Quality/Regulatory Supervisor (May 2018-Nov 2018)

• Managed a team of 5 direct and indirect reports – Involved project management, mentoring and performance reviews

• Represented the department in internal FDA audits and provided responses and requested documents

• Performed investigations for OOS and customer complaints through root cause analysis and CAPA Quality/Regulatory Supervisor (August 2017-May 2018)

• Established and maintained project plans via Smartsheet and oversaw technical team

• Created work instructions and SOPs for processes to be in compliance with domestic and international regulations Research and Development/Formulation Supervisor (August 2016-August 2017)

• Supervised a team of technicians, reviewed data and presented results to senior management

• Developed and monitored the team’s metrics/KPIs to ensure progress is aligned with the strategic business goals Research and Development Technician (May 2015-August 2016)

• Recorded and analyzed experimental data and provided recommendations for formulation improvements

• Gained experience with various analytical methods including titration, dissolution and friability EDUCATION

New Jersey Institute of Technology, Newark, NJ 2017-2020 Master of Science (M.S.) in Pharmaceutical Engineering - GPA: 3.96 Process Development and Design for Drug Product Manufacturing Rutgers the State University of New Jersey, New Brunswick, NJ 2008-2012 Bachelor of Science (B.S.) in Exercise Science

PROFESSIONAL CERTIFICATIONS

Project Management Professional (PMP®), Project Management Institute 2024 SKILLS

• Technical: CMC, Program Management, Portfolio management, Technical Operations, Supply Chain Management, Clinical Drug Development, Life-cycle management, cGMP, Smartsheet, ClickUp, Lean Six Sigma, FDA/EMA regulations, CBER/CDER, ERP/MRP software systems, FDA 21 CFR Part 211, 111, 101, Microsoft Office (Project, Excel, Word, PowerPoint)

• Soft: Team management, Cross-functional teamwork, Problem-solving, Adaptability, Analytical thinking LEADERSHIP/PROFESSIONAL MEMBERSHIPS

• Prevail Therapeutics/Eli Lilly and Company - Merger and Acquisition transition team leader

• Reliance Vitamin LLC. - Women’s Leadership Development member

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