Packaging Scientist
Packaging Scientist
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Job Description
- Preparation of design verification protocol and test reposts for combination products such as pen injectors autoinjectors and prefilled syringes.
- Author and/or participate in preparation of Design Controls (ISO 13485) and Risk Management (ISO 14971) for drug-device combination products
- Support preparation of technical package for Notified Body Opinion submissions
- Manage vendor interactions and communication for device suppliers primary packaging component suppliers artwork development secondary packaging development device assembly and testing
- Preparation of packaging documents Material code FG code Bill of Materials MPC test method development test method verification artworks print proofs transport study transfer checklist drawings layout trials reports specifications STP etc.
- Develop device assembly and automation for manufacturing. Evaluate concepts ensure development and participate in equipment qualification
- Identify and plan for device testing for primary container as per relevant USP and requirements
- Device primary functions testing with respect to relevant ISO standards (ISO 11608 ISO 11040 ISO 6236 etc.)
- Lead technical investigations of medical device and combination product
- Facilitate technology transfer of medical device and combination products from development to commercialization
- Application of statistical tools for data analysis
- Supporting global and site-specific projects including those related to combination products and drug delivery systems
- Keep current with ISO and FDA regulations respective to combination products. Train new and existing employees on Combination Product Requirements processes and procedures
- Keep stake-holders and team members informed with effective communication. The key stakeholders include Internal and External Manufacturing Sites R&D Quality Operations Product Development groups Regulatory Affairs Procurement and suppliers.
Qualifications :
- Bachelors or masters degree in science engineering biomedical packaging or a closely related technical field coupled with over 7 years of hands-on experience in the pharmaceutical or medical device industry specifically focused on drug delivery systems like pen injectors and autoinjectors
- Experience with design verification testing
- Seven plus years of relevant experience in medical devices or combination products
- Seven plus years in design control risk analysis and change control management for medical device or combination products
- Experience in combination product design verification (ISO 11608 ISO 11040) design controls (ISO 13485) risk management (ISO 14971)
- Experience with medical device or combination product commercialization operations support and materials/components
- Experience with pen injectors autoinjectors or other complex drug-delivery systems and associated pre-filled syringe systems or cartridges.
- Experience with device assembly and/or packaging equipment/automation and design for manufacturing
Additional Information :
About the Department
Integrated Product Development Organisation
We integrate our deep science capabilities and cutting-edge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a science-driven innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API Formulations Clinical Intellectual Property and Regulatory Affairs. We are serving 55 markets including USA Canada Europe China LATAM ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API) Oral formulations Parenteral (Injectables Opthalmics) & Other dosages
Our product development efforts drive a portfolio of more than 1000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1071 patents and also published over 1000 papers for peer review over the years.
Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.
Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
