R&D Engineer (Pharma) - Resume Example & Template

Resume of R&D Engineer (Pharma) in Text Format

ADITYA KISHORE

Phone: 9953776253 | Email: info@getsetresumes.com| LinkedIn: linkedin.com/company/getsetresumes

RESEARCH & DEVELOPMENT ENGINEER- leveraging 9+ years of experience

Innovative R&D Engineer with over nine years of industry experience. Designs and executes detailed experiments using risk assessments, appropriate scale-down models, QbD principles, and process characterization/modeling techniques. Adept at efficiently collaborating with key stakeholders (Clinical Operations, Quality, Compliance, Analytical, and MS&T) for business process optimization, and ensuring consistency.

PROFILE SUMMARY

• Possess a complete understanding of combination product medical product development.
• Demonstrated experience designing medical devices, and successfully translating concepts to clinical implementation.
• Proficient utilizing design and development tools including CAD systems.
• Understanding and functional knowledge of the statistics of quality as applied to medical device development.
• Demonstrated understanding of design for manufacturability.

CORE COMPETENCIES

• Products Research
• Product Formulation & Design
• Packaging & Device Development
• Process Development
• Pilot Plant Operations
• Material Development
• Modeling and Simulation (M&S)
• Design Verification & Validation
• Regulatory Compliance

PROFESSIONAL EXPERIENCE

Novo Nordisk India, New Delhi | Jan. 2020 – Present

Research & Development Engineer

• Develop new medical device designs to solve a wide range of technical challenges.
• Develop devices considered combination products in conjunction with cellular medicines and related formulations
• Write and review protocols, executes protocols, perform analyses and write and reviews reports for R&D purposes, and compliant with Design Controls as part of formal Design Verification & Validation.
• Support advancement of medical devices from concept through to clinical implementation using Design Control processes by preparing product designs for commercialization.
• Demonstrate a working knowledge of medical device development compliant with requirements.
• Utilize Risk Analyses, Failure Modes and Effects Analyses, Fault Trees, Fishbone Diagrams, and similar risk assessment and management tools.
• Act as technical subject matter expert for the design and development of medical devices representing Medical Device R&D on cross-functional teams including product development teams.
• Design and coordinate with 3rd parties to design/develop product packaging and labeling systems.
• Design devices, assemblies and components using Computer Assisted Design tools to create 3D models, drawings and manufacturing instructions Build prototypes, perform feasibility testing and evaluate designs. Perform root cause and failure analyses, identify and implement design, material, and process mitigations Source materials, products, and services from 3rd parties.
• Coordinate services and projects with 3rd party providers including CMOs
• Utilize a basic understanding of Design for Manufacturability principles so that product designs are manufacturable and cost-effective Support design transfer to manufacturing ensuring that products satisfy their intended use
• Utilize Geometric Dimensioning & Tolerance techniques to ensure accurate and unambiguous documentation of product designs.
• Responsible for authoring and reviewing Design Control documentation including, but not limited to, design requirements, trace matrices, risk management documents, specifications, and standard operating procedures.
• Author technical portions of regulatory submissions under the guidance of Regulatory Affairs.

TiVo Pharmaceuticals, New Delhi | Jan. 2018– Nov. 2019

Research & Development Engineer

• Contributed by developing new ideas and presented cogent research results to internal and external professionals.
• Led the design and characterization studies of regenerative medical devices in accordance with industry standards.
• Maintained a level of scientific knowledge in assigned area.
• Performed scientific literature searches and evaluations as required and understand/comply with accepted laboratory and safety procedures.
• Understood and applied current technology and evaluate related investigations and information from the literature.
• Documented scientific evidence following documentation requirements.
• Presented results of scientific research, development/assessment and handover activities, and be responsible for projects involving considerable research.
• Worked closely with the team to ensure the efficient progress of projects.
• Interfaced closely with Clinical Operations and Early Development organizations to execute and support clinical in-use characterization studies and related documentation.
• Interfaced with MS&T (Indian and International), External Manufacturing, Quality and Regulatory organizations to develop and execute on strategies for the commercialization of late-stage programs.

Moderna, Noida | Jul. 2014 – Nov. 2017

Research & Development Engineer

• Established and executed integrated development plans for drug-device combination products (primarily PFS) starting from the Drug Product interface through label and packaging operations.
• Served as the key interface connecting our internal development/quality/regulatory teams with various third parties (CDMOs, consulting groups, vendors, suppliers, etc).
• Oversaw the design, execution, and documentation of appropriate development, verification, and validation studies.
• Reviewed combination product technical documentation including DHF documents, design input requirements, test plans/protocol/reports, engineering assessments, and design outputs.
• Performed required risk assessments, implement appropriate mitigation strategies, and documented approaches through appropriate risk management systems.
• Advanced platform and functional initiatives through direct contributions and matrixed leadership.
• Supported authoring and review of regulatory submissions

ACADEMIC CREDENTIALS

Education – B.Tech Biomedical Engineering Indian Institute of Technology, Gandhinagar | 2014

PERSONAL DOSSIER

Languages Known: English, & Hindi