- Assist in the execution of process technology transfers and Commercial batches at manufacturing sites (in-house and CMO).
- Conduct scale-up, exhibit batches and commercial batches under supervision, ensuring proper documentation and parameter tracking.
- Support in the preparation and review of Batch Manufacturing Records (BMRs) and commercial 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 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.
Education: M.Pharm
Experience: 5-8 Years in manufacturing of Commercial validation batches and commercial launch with USFDA, EU, MHRA, ANVISA requirement etc.
Technical Skills: Expertise in preparing and reviewing regulatory documents and reports, Strong understanding of data management and documentation tools,
Soft Skills: Excellent written and verbal communication skills, Problem-solving mindset and proactive approach to challenges, Ability to work independently and as part of a team, Strong attention to detail and organizational skills
Skills Required
- M.Pharm
- 5-8 years experience in manufacturing commercial validation batches and commercial launch complying with USFDA, EU, MHRA, ANVISA
- Experience executing process technology transfers and commercial batches at manufacturing sites (in-house and CMO)
- Expertise preparing and reviewing regulatory documents, BMRs, validation protocols and reports
- Strong understanding of GMP compliance and batch documentation practices
- Experience with process investigations, deviation handling, troubleshooting during trial/validation batches
- Ability to support audits and regulatory submissions, respond to technical queries
- Proficiency with data management and documentation tools
- Excellent written and verbal communication skills
- Strong attention to detail, organizational skills, and ability to work independently and in teams
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.
