The Role
Support technology transfer and scale‑up for OSD products, providing technical oversight, executing batches, reviewing/approving validation and regulatory documents, driving investigations and remediation, and collaborating with Quality, Ops, Engineering and Development. Ensure validated, robust processes and product compliance. Frequent travel to CMOs (India and overseas) for on‑site support.
Summary Generated by Built In
Job 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.
- 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.
Skills Required
- Master's degree in Pharmacy, Biotechnology, or Life Sciences
- 2-6 years relevant MSAT/OSD technology transfer experience
- Strong knowledge of regulatory guidelines (USFDA, EMA, ICH, SUPAC)
- Ability to travel 40-70% to CMO locations (India and overseas) for on-site support
- Excellent communication and cross-functional collaboration skills; fluent English
- Proficiency in Quality by Design (QbD), Design of Experiments (DoE), and statistical analysis tools (e.g., Minitab)
- Wurster coating experience
- Regional language proficiency (advantage)
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
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.
