DifGen Pharmaceuticals

Senior Research Associate

DifGen Pharmaceuticals  •  State of Telangāna, IN (Onsite)  •  20 days ago
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Job Description

Job Location: Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072
Position Type: Full Time
Job Shift: Day
- 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.

QualificationsEducation: 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
DifGen Pharmaceuticals

About DifGen Pharmaceuticals

We are a US based Global Pharmaceutical company with a primary focus on developing complex high barrier to entry Generics and Specialty Pharmaceutical products that would help increase accessibility to high quality medication thereby leading to the creation of next generation healthy communities. We are driven by an earnest pursuit of redefining the accepted standards in pharmaceutical product development and commercialization. We consistently aspire to challenge standard thought processes to arrive at dependable solutions that create a paradigm shift in product development, quality, clinical affairs, regulatory sciences, and commercial strategy. Our talented team with some of the brightest minds have developed a holistic understanding of the nuances associated with the development of unique, commercially viable and difficult product lines across varying therapeutic areas and a broad array of dosage forms such as Injectables, Ophthalmics, Topicals, Biologicals, Drug Devices, Soft Gels, Solid Orals & Suspensions.

Industry
Chemicals & Materials
Company Size
51-200 employees
Headquarters
Hyderabad, IN
Year Founded
Unknown
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