The Role
Support execution of commercial launches, scale-up and validation batches at internal and CMO manufacturing sites. Prepare and review BMRs and validation protocols/reports, coordinate cross-functional knowledge transfer, participate in investigations and deviation handling, assist equipment selection, support regulatory submissions and audits, and maintain GMP-compliant documentation and reporting.
Summary Generated by Built In
- Assist the execution of commercial launches and process validation batches at manufacturing sites (in-house and CMO).
- Execute scale-up and exhibit batches under supervision, ensuring proper documentation and parameter tracking.
- Support in the preparation and review of Batch Manufacturing Records (BMRs) and validation protocols/reports.
- Coordinate with R&D, QA, QC, Regulatory Affairs, and Manufacturing teams for effective knowledge transfer and execution.
- Participate in process investigations, troubleshooting, and deviation handling during trial and commercial validation batches.
- Assist in equipment selection and capacity assessment based on product-specific requirements.
- Ensure document readiness for regulatory submissions, respond to technical queries, and support audit preparation.
- Support internal and external/vendor audits by providing required documentation and technical inputs.
- Prepare data summaries, technical reports, and presentations as per project or management requirements.
- Maintain accurate records, follow applicable SOPs, and ensure strict GMP compliance in all operations.
M. Pharma with 2-5 years of experience in execution of process validation batches
Skills Required
- M. Pharma degree
- 2-5 years experience executing process validation batches
- Experience preparing and reviewing Batch Manufacturing Records (BMRs)
- Knowledge of validation protocols and report preparation
- Strict GMP compliance and adherence to SOPs
- Experience coordinating with R&D, QA, QC, Regulatory Affairs, and Manufacturing teams
- Support for audits and regulatory submission document readiness
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The Company
What We Do
DifGen Pharmaceuticals is a US-based global pharmaceutical company specializing in the development and manufacturing of complex, high-barrier-to-entry generic and specialty pharmaceutical products. The company focuses on creating dependable solutions in product development and commercialization to increase accessibility to high-quality medications, thereby leading to the creation of next-generation healthy communities.
