Research Scientist - Tech Transfer

Aveva Drug Delivery Systems Inc; Hyderabad; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Aveva Drug Delivery Systems Inc. seeks a highly experienced MSAT/OSD technology transfer professional to support internal sites and CMOs, driving validated processes during tech transfer and scale‑up.

You will review documentation, monitor batches, and work cross‑functionally with Quality, Operations, Engineering and Development. Requirements include 5–8 years MSAT/OSD transfer experience, postgraduate degree in Pharmacy/Biotech/Life Sciences, strong knowledge of USFDA/EMA/ICH/SUPAC, and

Qualifications

• MSAT/OSD technology transfer experience (5–8 years).
• Postgraduate in Pharmacy/Biotech/Life Sciences is required.
• Strong knowledge of USFDA, EMA, ICH and SUPAC guidelines.
• Proficiency in QbD, DoE and statistical analysis tools (Minitab).
• Excellent communication and cross‑functional collaboration skills.
• Fluent in English; regional language skills are a plus.
• Travel readiness: 40–70% to CMO locations across India and overseas.

Responsibilities

• Provide technical support to internal sites and CMOs, ensuring validated processes.
• Act as technical expert during technology transfer and scale‑up activities.
• Review and approve technical documentation for submissions.
• Execute and monitor batches, applying scale‑up factors for optimization.
• Collaborate with Quality, Operations, Engineering, and Development.

Skills

MSAT/OSD tech transfer

QbD

DoE

Statistical analysis (Minitab)

Cross‑functional collaboration

English fluency

Regulatory knowledge (USFDA, EMA, ICH,

Education

Postgraduate in Pharmacy/Biotech/Life Sciences

Tools

Minitab

Job description

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.Postgraduate in Pharmacy/Biotech/Life Sciences.5–8 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.