DifGen Pharmaceuticals

Research Scientist - Tech Transfer

DifGen Pharmaceuticals  •  State of Telangāna, IN (Onsite)  •  5 hours ago
Apply
AI can make mistakes so check important info. Chat history is never stored.
64
AI Success™

Job Description

Job DetailsJob Location: Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072Salary Range: ₹5,555.00 - ₹7,777.00 Salary/yearJob Shift: DayJob Title: Research Associate – MSAT (Technology Transfer), OSD
Key Responsibilities:
Provide technical support to internal sites and CMOs, ensuring validated processes.
Act as technical expert during technology transfer and scale‑up activities.
Apply science‑ and risk‑based approaches to maintain sustainable product quality.
Review and approve technical documentation (BMRs, Process Validation protocols/reports, Stability protocols/reports, risk assessments, validation documents, RA documents) for timely submission.
Execute and monitor batches, applying scale‑up factors for process optimization.
Maintain oversight of CQAs, CMAs, and CPPs to ensure process robustness.
Support validation strategies, including protocol and report preparation.
Ensure products remain in a validated state through revalidation planning.
Collaborate cross‑functionally with Quality, Operations, Engineering, and Development.
Lead/support root cause investigations and drive remediation initiatives.
Provide documentation and data for product transfers and launches.
Travel 40–70% to CMO locations across India and overseas for on‑site support.
Ensure compliance with regulatory and quality standards during transfers.
Wruster coating experience will be considered an added advantage.
Master's in pharmacy
Postgraduate in Pharmacy/Biotech/Life Sciences.
2–6 years of relevant MSAT/OSD technology transfer experience.
Strong knowledge of regulatory guidelines (USFDA, EMA, ICH, SUPAC).
Proficiency in QbD, DoE, statistical analysis tools (e.g., Minitab) preferred.
Excellent communication and cross‑functional collaboration skills.
Fluent in English; regional language proficiency is an advantage.
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
Social Media