Harish Dhanala
Stouffville,Canada
Summary
Accomplished Process Engineering Specialist with over 13 years of experience in pharmaceutical manufacturing, regulatory compliance, and cross-functional team leadership. Proven expertise in technology transfer, process validation, and technical support within FDA-regulated environments. Adept in managing end-to-end phases of drug development and manufacturing scale-up, with a focus on innovation, operational efficiency, and quality excellence. Demonstrated leadership in supervising teams, overseeing SOP development, and ensuring regulatory alignment.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Process Engineering Specialist II
Teva Pharmaceuticals Canada
Stouffville, ON
06.2023 - Current
- Lead end-to-end technology transfer and validation of complex dosage forms including orphan and anti-cancer drugs, ensuring alignment with regulatory and manufacturing standards.
- Spearhead development and implementation of master validation plans, process risk assessments, and process improvement strategies.
- Supervise departmental operations, mentor technical staff, and oversee performance management activities.
- Drive resolution of manufacturing challenges through incident investigation coordination and root cause analysis.
- Collaborate with Regulatory Affairs to support submission requirements including ANDA and 505(b)(2) filings.
- Author and manage SOPs and training documents to maintain compliance and promote continuous improvement.
Assistant Manager
AET Laboratories
Hyderabad, India
03.2017 - 08.2022
- Directed technology transfer activities from R&D to commercial scale including process optimization and GMP batch production.
- Led a team in addressing scale-up issues, enhancing operational efficiency and regulatory compliance.
- Supported development and technical documentation of immediate-release formulations across multiple therapeutic areas.
Executive & Project Lead
Aizant Drug Research Solutions Pvt. Ltd
Hyderabad, India
10.2013 - 03.2017
- Managed formulation projects including development of nano-suspension technologies for improved bioavailability.
- Drafted SOPs and technical reports, ensuring regulatory compliance and operational consistency.
- Executed cGMP-compliant workflows and contributed to technical document audits.
Team Member
IDRS Labs Pvt. Ltd
Bengaluru, India
09.2015 - 12.2015
- Collaborated on formulation R&D, contributing to data analysis, documentation, and protocol development.
Project Trainee
Aizant Drug Research Solutions Pvt. Ltd
Hyderabad, India
11.2012 - 09.2013
- Assisted in pre-formulation studies and initial formulation development for clinical trials.
Education
Master of Science - Regulatory Affairs
Northeastern University
Toronto, ON06.2024
Master of Science - Industrial Pharmaceutics
Jawaharlal Nehru Technological University
01.2013
Bachelor of Science - Pharmacy
Rajiv Gandhi University of Health Sciences
01.2010
Skills
- Technology transfer and validation skills
- Scale-Up & Exhibit Batch Manufacturing
- Regulatory Documentation & Compliance (FDA, EU, Health Canada)
- SOP & Protocol Development
- Technical Team Supervision & Training
- Cross-functional Collaboration
- Project & Operations Management
- Nanotechnology & Formulation Expertise
- CGMP & Quality Systems
- Investigations & Root Cause Analysis
Certification
- ECTD Module Preparation & Submission
- FDA & Health Canada Regulatory Guidelines
- Supervisory Skills and Performance Management
Publications
- Hot Melt Extruded Aprepitant Soluplus Dispersion: Stability and In-Vitro Study
- Patent: Nano Particulate Ivacaftor Formulation (WO/2016/199085A1)
- Patent: Pirfenidone-containing Tablet/Capsule (18202096.6-1114)
Regulatory Contributions
Supported ANDA and 505(b)(2) filings for US, EU, and Canadian markets. Contributed to regulatory documentation, lifecycle management, and response to health authority queries.
Timeline
Process Engineering Specialist II
Teva Pharmaceuticals Canada
06.2023 - Current
Assistant Manager
AET Laboratories
03.2017 - 08.2022
Team Member
IDRS Labs Pvt. Ltd
09.2015 - 12.2015
Executive & Project Lead
Aizant Drug Research Solutions Pvt. Ltd
10.2013 - 03.2017
Project Trainee
Aizant Drug Research Solutions Pvt. Ltd
11.2012 - 09.2013
Master of Science - Industrial Pharmaceutics
Jawaharlal Nehru Technological University
Bachelor of Science - Pharmacy
Rajiv Gandhi University of Health Sciences
Master of Science - Regulatory Affairs
Northeastern University