Job Title: R&D Packaging Development Specialist – Injectables
Company Overview:
A leading global pharmaceutical company, dedicated to delivering innovative and high-quality healthcare solutions, is seeking talented professionals to join our dynamic team. We are committed to excellence in research and development, manufacturing, and bringing advanced therapies to patients worldwide. Our R&D team plays a pivotal role in our success, driving innovation across various therapeutic areas and ensuring the integrity and market readiness of our products.
About the Role:
We are looking for a highly motivated and experienced R&D Packaging Development Specialist to join our team in Baroda. This critical role focuses on the development of robust and compliant packaging solutions specifically for our injectable products. You will be instrumental in driving packaging innovation from initial concept through to commercialization, ensuring adherence to regulatory standards and product quality. This position offers an excellent opportunity to contribute to the lifecycle of essential pharmaceutical products.
Key Responsibilities:
- Conduct comprehensive characterization of Reference Listed Drug (RLD) pack samples.
- Finalize packing configurations for exhibit batch packing of new generic products and New Drug Applications (NDAs) as per project requirements.
- Identify, evaluate, and develop new primary and secondary packaging materials, including sourcing and onboarding new vendors.
- Manage the end-to-end process of mold development and subsequent validation for primary and secondary packaging components.
- Provide expert packaging support and documentation to the Regulatory team for ANDA/NDA filings targeting regulated markets.
- Prepare and periodically revise detailed packaging material specifications.
- Develop crucial documentation such as Master Packaging Configurations (MPC), Failure Mode and Effects Analysis (FMEA), Technical Agreements (TA), Design History Files (DHF), and Analytical Failure Mode and Effects Analysis (AFMEA).
- Prepare, review, and execute Development Study protocols and reports.
- Perform functional tests on packaging materials and systems to ensure compliance with all relevant regulatory requirements.
Qualifications:
- A Degree in Packaging Development from a recognized institution (such as IIP – Indian Institute of Packaging) or an M.Pharm qualification.
- Minimum of 3 years of hands-on experience in R&D Packaging Development, with a specific focus on Injectable pharmaceutical products.
- Strong knowledge of pharmaceutical packaging regulations, quality systems, and industry best practices.
- Demonstrated analytical, problem-solving, and communication skills.
Location:
Baroda
How to Apply:
Interested and qualified candidates are encouraged to submit their detailed resume and a cover letter outlining their relevant experience. Please apply through our designated career portal or company website, referencing “R&D Packaging Development Specialist – Injectables” in your application. We thank all applicants for their interest, however, only those selected for an interview will be contacted.
