Executive / Senior Executive - Downstream Process Development

0 - 5 years

2 - 7 Lacs

Posted:8 hours ago| Platform: Naukri logo

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Full Time

Job Description

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Key Responsibilities

  • Execute and optimize various DSP unit operations, including chromatography, filtration (UF/DF), and centrifugation.
  • Support process scale-up activities and technology transfer to manufacturing sites.
  • Participate in early-stage process development and late-stage activities, including Stability-Indicating Methods (SDM), Process Characterization (PC), and resin life cycle studies.
  • Prepare and review critical documentation such as regulatory documents, logbooks, LNBs (Laboratory Notebooks), protocols, and technical reports.
  • Ensure all processes comply with Qualification standards (Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)).
  • Maintain accurate documentation of all experimental data and evidence generated during development.

Required Skills & Experience

  • Experience Range:

    0 to 10 Years in a relevant biopharmaceutical or R&D setting.
  • Hands-on experience with core DSP unit operations is essential.
  • In-depth DSP development experience for both microbial and mammalian expression platforms is highly preferred.
  • Exposure to scale-up and technology transfer processes.
  • Good working knowledge of cGMP principles and Quality Management Systems (IQ, OQ, PQ).
  • Strong analytical, problem-solving, communication, and documentation abilities.

edukondalu.mallula@vimta.com

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Vimta Labs

Laboratory Services

Hyderabad

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