CMC Drug Development Project Manager

ASHU AGGARWAL MS (Pharm Sci.), PMP®

CMC Project Manager Cross-Functional Leadership External Manufacturing Global Drug Development

https://www.linkedin.com/in/ashuaggarwal/ US citizen

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

July 07, 2026

Dear Hiring Manager,

I lead global CMC programs across development, technology transfer, commercialization, and post-approval lifecycle management for a portfolio comprising small molecules, biologics (mAbs and ADCs), cell therapy programs, and medical devices. In my current role, I act as the CMC program integrator, bringing together teams across Formulation, Analytical Development, MSAT, Operations, Supply Chain, Quality, Regulatory, and external CDMOs to drive execution across cGMP manufacturing and the broader CMC lifecycle.

My experience includes building and executing integrated CMC plans, managing critical paths, budgets, and cross-functional dependencies, while driving deviations, CAPAs and change controls to closure supporting regulatory milestones and supply continuity. I lead Joint Steering Committee meetings and present program updates to executive stakeholders, ensuring clear visibility into progress, risks, financials, and key trade-offs. I use scenario and risk-based planning to evaluate development options, manage capacity constraints, and support programs with fixed regulatory timelines, including IND submissions.

Alongside development and clinical programs, I support post-approval lifecycle activities for commercial products, including supplier qualification, raw material and container-closure changes, packaging and labeling solutions, revalidation, and shelf-life extensions to maintain compliant supply.

My program leadership is grounded in firsthand pharmaceutical development experience. I began in pre-formulation development, collaborating with Analytical, Quality, Regulatory, Toxicology, and DMPK teams before moving into formulation-focused intellectual property supporting drug development. Combined with my experience leading global CMC programs within a CDMO environment, I bring both a sponsor’s scientific perspective and practical experience overseeing outsourced development and manufacturing, enabling effective partnerships and informed decision-making throughout the CMC lifecycle.

I would welcome the opportunity to bring my experience in global CMC program leadership and cross-functional execution to your organization.

Thank you for your time and consideration.

Kind Regards,

Ashu Aggarwal

PROFESSIONAL SUMMARY

I bring end to end CMC leadership experience spanning development, technology transfer, commercialization, and post-approval lifecycle management across a portfolio of small molecules, biologics (mAbs and ADCs), cell therapy programs, and medical devices. In this role, I lead integrated execution across cGMP environments and global drug substance and drug product networks, driving deviations, CAPAs and change controls to closure supporting regulatory milestones and supply continuity.

I develop integrated CMC plans, dashboards, roadmaps and financials that provide visibility into timelines, budgets, risks, and critical paths across concurrent programs. I facilitate Joint Steering Committees and partner across Technical, Quality, Regulatory, Manufacturing, and Supply Chain functions to advance portfolio execution.

Alongside development and clinical programs, I support post-approval lifecycle activities for commercial products, including supplier qualification, raw material and container-closure changes, packaging and labeling solutions, revalidation, and shelf-life extensions to maintain compliant supply.

I combine this with a strong scientific foundation in pharmaceutical development, including pre-formulation, analytical development and formulation-focused intellectual property, enabling me to bridge scientific strategy with CMC leadership across outsourced manufacturing networks.

CORE COMPETENCIES

CMC Program Leadership & Governance

Strategic Planning & Portfolio Management

Technical Execution & CMC Quality Systems

Cross-functional governance; Joint Steering Committees; Executive reporting; global CDMO oversight; lifecycle execution; Legal / Quality / Supply Chain alignment for SOWs, MSAs, and Quality Agreements.

Critical path management; scenario-based planning; capacity and resource planning; risk mitigation; budget oversight; parallel CMC program execution.

cGMP Operations; Technology transfer; clinical and commercial supply; change controls; deviations; CAPAs; cross-functional coordination across Formulation, Analytical, MSAT, Operations, QA, Supply Chain.

WORK EXPERIENCE

Site Lead Project Manager – Integrated Projects / Technical Project Manager – Finished Product Manufacturing, 12/2024 - Current

Piramal Pharma Solutions, Lexington, KY (www.piramalpharmasolutions.com)

Global Portfolio Scope: Lead end to end execution of a nine-project global CMC portfolio spanning small molecules, biologics (mAbs and ADCs), cell therapy programs, and medical devices across oncology, pain management, and regenerative medicine.

Programs span the US, UK, Canada, Korea, China, and India, covering early-phase development through clinical and commercial supply, including multi-site drug substance and drug product networks.

Key Program Leadership:

Immunome - Oncology Program (Biologic)

Serve as Site Lead CMC Project Manager, coordinating global CDMOs, analytical vendors, and cross-functional teams to maintain program timelines and clinical supply continuity.

Oversee sterile fill-finish operations for light-sensitive ADCs across liquid and lyophilized presentations.

Manage multi-site manufacturing strategy (linker-payload, antibody, conjugation, fill-finish) across US, EU, and Asia.

Lead cross-functional planning to ensure clinical supply readiness through stability programs, release testing, batch disposition, and uninterrupted supply for global clinical trials.

Medipost - Regenerative Cell Therapy (Medical Device)

Lead drug product development for commercially approved stem cell therapy (Cartistem®).

Lead introduction of a new aseptic manufacturing process at the site, supporting successful media fill qualification before GMP manufacturing.

Develop risk-based execution strategies supporting IND and clinical manufacturing timelines.

Develop labeling and packaging processes from the ground up, including vial labeling, pouching, and packaging workflows for GMP manufacturing and clinical supply.

Identify, assess, select, and qualify external vendors for specialized fill pumps supporting viscous formulation, ethylene oxide sterilization, and package integrity testing to support US development.

Dechra / Invetx - Pain Management (Veterinary biologic)

Manage monoclonal antibody fill-finish program for osteoarthritis therapeutic.

Coordinate end to end clinical supply execution across development, manufacturing, and CDMO partners.

Across this portfolio, I provide CMC program leadership through governance, cross-functional integration, and global external partner management, including:

CMC Governance & Program Leadership

Lead Joint Steering Committees and executive governance forums across global CMC programs.

Translate multi-site program status into decision-ready insights on timelines, risks, and supply continuity.

Partner with Legal, Quality, and Supply Chain on execution of SOWs, MSAs, and Quality Agreements with sponsors and external CDMOs.

CMC Execution & Supply Chain Delivery

Manage high-complexity CMC programs with fixed regulatory milestones (including IND submissions) using risk-based and critical-path planning.

Lead cGMP execution across technology transfer, clinical supply, commercial supply, and lifecycle activities, including global shipment documentation to ensure uninterrupted supply.

Drive deviation, CAPA, and change control closure to ensure uninterrupted supply.

Coordinate global supply prioritization, vendor integration, and material risk mitigation across concurrent programs.

Regulatory, Quality & Lifecycle Management

Drive CMC documentation readiness for IND submissions by coordinating cross-functional inputs and submission-ready cGMP packages.

Support EU Annex 1 compliance through documentation for aseptic processing, contamination control, sterilization, environmental monitoring, and facility readiness.

Manage post-approval lifecycle activities including supplier qualification, raw material and container-closure changes, labeling updates, revalidation and shelf-life extensions.

Operational & Reporting

Develop integrated dashboards and reporting tools to support program tracking, risk visibility, and milestone execution across CMC portfolios.

Project Manager – CDMO, 04/2024 – 11/2024

August Bioservices, Nashville, TN (www.augustbio.com)

Project Oversight:

Managed concurrent CMC development, technology transfer, clinical supply, commercial readiness, and capital equipment programs across small molecule and medical device portfolios, leading scope, schedule, budget, risk, and cross-functional execution.

Key Programs:

Organ Recovery Systems - Organ Preservation (Medical Device / Combination product)

Led commercial site readiness for SPS® and KPS® products through formulation confirmation, engineering batch, raw material readiness, and manufacturing preparation for commercial cGMP production.

Managed a multi-million dollar aseptic filling system implementation, coordinating with Plümat (Germany) and Telstar (UK) through FAT, SAT, installation, commissioning, qualification (IQ/OQ/PQ), and calibration of an isolator-based IV bag filling and overwrapping system.

Coordinated Equipment vendors, Engineering, Validation, Manufacturing, Quality, and Supply Chain to integrate new manufacturing capability into commercial operations.

Provectus Biopharmaceuticals - Tumor-targeted therapy (Small Molecule)

Managed tech transfer and clinical batch execution for injectable oncology therapy.

Program Execution, Governance & Client Management

Led client and internal governance meetings, including status reviews, stage-gates, and risk planning; tracked critical path activities, mitigation strategies, scope, schedule, and budget constraints across concurrent programs.

Presented program dashboards and execution updates, providing visibility into milestones, risks, dependencies, and GMP manufacturing readiness.

Supported cGMP manufacturing readiness through raw material tracking and release coordination, equipment qualification readiness, batch disposition workflows, and finished product shipment execution.

Served as primary liaison across Business Development, Purchasing, Technical Development, MSAT, Operations, Quality, Supply Chain, and external vendors to align execution and deliver program milestones.

Supported client person-in-plant activities during manufacturing campaigns, facilitating technical discussions, risk reviews, and cross-functional alignment between client and internal teams.

Freelance Project Management Consultant, 03/2019 – 03/2024

Woodbridge, NJ

Delivered PMP certification training, managed digital content projects, and supported process improvement initiatives while maintaining part-time consulting engagements in project management and training.

Production Manager - Learning, 01/2018 – 02/2019

SS&C Technologies, New York City, NY (www.ssctech.com)

Led four cross-functional teams across Design, Development, and Quality; managed end to end lifecycle of cloud – based program portfolios.

Implemented rotational governance system that improved departmental efficiency by 13.5% - 16% QoQ, ensuring annual targets were met on schedule.

Project Support, 07/2017 – 09/2017

Colgate Palmolive, New York City, NY (www.colgatepalmolive.com)

As a contractor with the Fortune 500 company Colgate, I supported Colgate Palmolive’s Global Program Rollout across NA, LATAM, Asia; maintained program dashboards, status reports, and executive presentations.

Project Coordinator, 04/2015 – 06/2017

TechEnzyme Inc., Edison, NJ

Coordinated backend program operations and interfaced with SMEs to ensure consistent project delivery and alignment with client requirements.

Head Trainer – Intellectual Property (IP), 10/2009 – 09/2014

World Intellectual Property Organization (WIPO), Geneva, Switzerland (www.wipo.int)

Spearheaded the full lifecycle of global IP learning programs for international clients; led and managed a team of four trainers.

Facilitated stakeholder alignment across complex, multi-national initiatives to ensure successful program execution.

Research Scientist – IP, 08/2007 – 09/2009

Laurus Labs, Hyderabad, India (https://www.lauruslabs.com)

Managed Formulation development patent portfolio; filed USPTO, WIPO- PCT, EPO applications; awarded CEO Excellence Award.

Scientist – IP, 01/2006 – 01/2007

Confederation of Indian Industry, Hyderabad, India (www.cii.in)

Deputation program with India’s Department of Science and Technology; filed patents for Pharma companies; trained R&D team on IP requirements.

Junior Scientist – Pre Formulation Development, 08/2004 – 11/2005

Dr. Reddy’s Laboratories, Hyderabad, India (www.drreddys.com)

Worked in Discovery Research Division in a GLP environment; prepared pre-formulations of New Chemical Entities (NCEs); liaised across Analytical, Quality, Regulatory, Toxicology, DMPK.

SELECTED PUBLICATIONS / SEMINARS

Influence of operational variables in multi-particulate delayed release systems for colon-targeted drug delivery of celecoxib using extrusion spheronization© in Asian Journal of Pharmaceutics (Vol. 4, 102-109 (2), 2010).

Parallel Imports: Delivered seminar at World Intellectual Property Organization, Geneva, Switzerland in June 2008.

Biodegradable PEGylated microspheres and nanospheres© in American Journal of Drug Delivery (Vol. 2, 157-171 (15), 2004).

PROFESSIONAL DEVELOPMENT

Foundations of GMP, Medicinal Products, 2023 USP Education

ICH – GCP: Good Clinical Practices, 2023 Udemy Education

Project Management Professional (PMP®), 2016 - 2026 Project Management Institute, PA

EDUCATION

MS (Pharmaceutical Science) 3.88/4.0, 2002-2004

Panjab University, India

BS (Pharmaceutical Science) 3.93/4.0, 1997-2001

Garhwal University, India

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