Team Lead - Packaging DDCP

Technical lead is responsible for coordination and of technical activities related to devices and combination products for both internally and externally manufactured products to support reliable product supply and quality. Technical lead is responsible for combination product development design controls risk management and usability/human factors engineering.

Leverage comprehensive knowledge of relevant guidance regulations standards and industry best practices in the design and development of medical devices and combination products.

Lead technical efforts to evaluate appropriate device technologies by conducting exploratory research to gather user insights and design trends translating user needs into product and systemlevel requirements and specifications.

Provide expertise in all aspects of combination product development (primary container device functional parameters device assembly testing design verification threshold analyses secondary packaging IFU development) and risk management throughout the product development process ensuring compliance with internal processes and external standards.

Develop and maintain essential documentation including design and development plans design history files and traceability matrices. Actively participate in and drive design reviews and design change controls.

Manage vendor interactions and communication for notified body opinion device suppliers packaging component suppliers human factors user research and visual design.

Apply sound understanding of combination product regulatory requirements to compile CMC sections for ANDA/NDA.

Drive program excellence while ensuring efficient and timely escalation of urgent issues/risks to leadership.

Participates and leads product quality investigations to identify root cause and implement corrective actions. Supports the management of exception documents and Corrective and Preventive Actions.

Develop and implement robust testing strategies to assess the performance safety and efficiency of combination products.

Ensure compliance with relevant regulatory guidelines and standards (e.g. FDA EMA) throughout the product development lifecycle.

Stay abreast of emerging trends technologies and regulatory changes in the drugdevice combination product field.

Manage multiple projects simultaneously ensuring timely delivery of milestones.

The role will work crossfunctionally with R&D functions (regulatory affairs formulation clinical medical affairs and project management) as well as global manufacturing supply chain quality and compliance to execute activities needed to ensure products meet patient needs and current device regulatory requirements.

Qualifications :

Advanced degree in Mechanical Engineering Electrical Engineering Biomedical Engineering or a related technical discipline with 10 years of relevant industry experience in combination product development or advanced drug delivery device development with a major pharmaceutical biotechnological or a generic pharmaceutical company.

Demonstrated experience in combination product development including prefilled syringes prefilled cartridges pen injectors autoinjectors custom delivery devices for delivering complex formulations.

Understanding of system thinking (drug primary container device) and experience with human factors/ usability engineering.

Experience with the development of connected devices is desirable but not required.

Strong expertise in experimental design statistical analysis and data interpretation.

Experience working within device standards: Design Controls 21CFR 820.30 Risk Management (ISO 14971; Quality Management (ISO 13485; Needlebased injection systems (ISO 116081; Good Manufacturing Practices 21 CFR Part 4 21 CFR 210/211 21 CFR 820; EU Medical Device Requirements (EU MDR 2021; Medical Electrical Equipment (EN 60601 and related requirements ISO 11040 ISO 3951 and ISO 2859.

Proven experience with ANDA/NDA filings and maintaining Design History Files for combination products.

Strong analytical and problemsolving skills with the ability to think creatively and innovatively.

Excellent communication and interpersonal skills with the ability to work effectively in a multidisciplinary team environment.

Additional Information :

About the Department

Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cuttingedge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a sciencedriven innovationfocused 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 :

Fulltime