DANASHANKARA MALLAPPA
Mississauga,ON
Summary
Goal-oriented individual dedicated to continuous improvement and driving positive business impact. Talented problem-solver and leader with high-level technical acumen. Motivates teams to reach performance goals and business objectives. Proficient in Product Development, Technical Operations and Commercial Manufacturing. Known for ability to adapt to new situations.
Overview
26
26
years of professional experience
Work History
Senior Process Engineering Specialist
Thermofisher Scientific
01.2017 - Current
- Led the execution of projects involving the transfer of products from client sites or other sites within the Thermo Fisher network, focusing on feasibility, scale-up, and validation stages
- Developed proposed process trains for new products with potential entry into the commercial manufacturing plant
- Actively participated in meetings to ensure the timely progress of mid-stage development and commercial tech transfer projects, ensuring alignment with site capabilities and capacity
- Achieved a seamless and organized transition of development projects into a commercial environment, ensuring timely satisfaction of regulatory filings
- Reviewed development and commercial batch records to ensure containment, safety, and accuracy of the process, as well as the seamless operation of the overall process
- Prepared procedures, protocols, risk assessments and reports for new product batches
- Investigated manufacturing deviations, Out of Specification (OOS) incidents, and market complaints promptly and effectively
- Provided scientific and technical assessments directly to the investigation or quality organization to facilitate conclusive resolutions to audits, complaints, and critical deviations
- Provided support to the shop floor during scale-up, registration, validation, and initial commercial batches, while assisting in resolving processing difficulties
- Implemented process and equipment changes to address quality issues, improve efficiency, and ensure regulatory compliance
- Actively engaged in continuous improvement initiatives for process enhancement and contributed to the acquisition of new equipment to incorporate technological advancements
- Supported the manager in preparing business proposals for new business initiatives
- Collaborated with junior team members and students, providing strength-based mentoring from a technical perspective to enhance their knowledge and expertise
- Actively participated in daily planning meetings (Value Stream Mapping) as needed, occasionally stepping in for the manager during various Business Review meetings with clients.
Technical Project Leader, Level I, II & Senior
Patheon Inc.
01.2008 - 01.2017
- Led and supervised a team of four to six scientists/technologists, contributing to the development of a highly skilled and talented team
- Successfully managed projects with challenging timelines and clearly defined resources
- Conducted daily department huddles to proactively address and resolve conflicts between teams
- Led weekly planning and resource meetings for the entire department
- Contributed as a member of the supervisory team in the production planning for commercial manufacturing environments
- Annually reviewed scientific publications within the development group for science conferences, such as AAPS
- Developed diverse drug product formulations and conducted process improvement studies for new chemical entities from early development to late-stage, offering innovative solutions
- Provided technical support and optimized process and equipment parameters for feasibility scale-up, clinical, and registration batches
- Coordinated with the Technical Operations group to ensure a smooth and orderly transition of development projects into the commercial environment
- Prepared protocols and technical reports outlining project challenges, formulation, and process development rationale, observed results, and provided recommendations for further improvements
- Actively participated in regular project meetings with clients, providing updates and recommendations for the project
- Led client interactions during observation visits for feasibility, clinical, and registration batch manufacturing
- Investigated manufacturing deviations and Out of Specification (OOS) incidents in a timely manner
- Conducted weekly analysis of quality trends and department metrics, providing reports to the management for further actions
- Collaborated with vendors and suppliers to organize presentations on new excipients, aiming to explore the potential advantages for use in product development
- Conducted regular audits of the development area and took appropriate actions in a timely manner
- Prepared proposal write-ups for the quotes group to generate formal business proposals for prospective new clients.
Technologist /Scientist
Patheon Inc.
01.2004 - 01.2008
- Conducted excipient compatibility studies and feasibility trials in accordance with the approved formulation development protocol
- Executed the setup, operation, and cleaning of development equipment in accordance with Standard Operating Procedures (SOPs)
- Prepared protocols and batch records for the manufacturing of development batches
- Produced development feasibility and clinical batches in accordance with the approved batch record
- Provided training to newcomers on dry/wet granulation, compression, encapsulation, and coating processes using development equipment
- Ensured the maintenance of processing rooms and equipment in optimal condition
- Participated in project meetings with the technical project leader and client.
Manufacturing Executive Level I
Dr.Reddy’s Laboratories Ltd., India
01.2002 - 01.2003
- Supervised the manufacturing process with a team of ten to fifteen technicians during each shift
- Collaborated with R&D to optimize process parameters for Effervescent and Bi-layer tablets
- Assisted in troubleshooting various technical problems that occurred during the manufacturing and packaging process
- Assisted in the procurement of new equipment and facilitated the subsequent installation process
- Periodically monitored the performance of technicians and provided necessary training to enhance productivity
- Participated in the performance review of technicians
- Generated and provided periodic productivity reports and metrics for the department.
Production Supervisor
Cipla Ltd., India
01.1998 - 01.2002
- Supervised the manufacturing process with a team of ten to fifteen technicians during each shift
- Collaborated with R&D to optimize process parameters for Effervescent and Bi-layer tablets
- Assisted in troubleshooting various technical problems that occurred during the manufacturing and packaging process
- Assisted in the procurement of new equipment and facilitated the subsequent installation process
- Periodically monitored the performance of technicians and provided necessary training to enhance productivity
- Participated in the performance review of technicians
- Generated and provided periodic productivity reports and metrics for the department.
Education
Master of Pharmacy -
Bangalore University, India
01.1997
Bachelor of Pharmacy -
ThermofisherCiplaexcipientsPatheonPatheonKuvempu University, India
01.1995
Skills
- Post Graduate degree in Pharmaceutical Science (Pharmacy)
- Possess 14 years of expertise in drug product development, complemented by 11 years of experience in Technical Operations and Commercial drug product manufacturing
- Demonstrates excellent proficiency in Good Manufacturing Practices (GMP) and comprehensive understanding of Food and Drug Administration (FDA) compliance
- Demonstrates robust team leadership and development skills, supported by a Leadership Certificate from the Schulich School of Business
- Proficient in SAP, Minitab, TrackWise, and MS Office applications, including Word, Excel, and PowerPoint
- Management Collaboration
- Customer Relations
- Process Improvement
Timeline
Senior Process Engineering Specialist
Thermofisher Scientific
01.2017 - Current
Technical Project Leader, Level I, II & Senior
Patheon Inc.
01.2008 - 01.2017
Technologist /Scientist
Patheon Inc.
01.2004 - 01.2008
Manufacturing Executive Level I
Dr.Reddy’s Laboratories Ltd., India
01.2002 - 01.2003
Production Supervisor
Cipla Ltd., India
01.1998 - 01.2002
Master of Pharmacy -
Bangalore University, India
Bachelor of Pharmacy -
ThermofisherCiplaexcipientsPatheonPatheonKuvempu University, India
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