Scientist/ Principal Scientist/Senior Principal Scientist

2 weeks ago

Tirupati, Andhra Pradesh, India Enzene Biosciences Ltd Full time

We're Hiring | Scientist / Principal Scientist / Senior Principal Scientist – Advanced Analytical Technology (AAT)

Designation subject to experience

Enzene Biosciences Ltd, an innovation-led biotech company backed by Alkem, is a pioneer in continuous biologics manufacturing and a trusted partner in biosimilars and CDMO services. As part of our growth journey, we are looking for an experienced leader to join our Advanced Analytical Technology (AAT) team.

Location: Pune, India

Role Overview

This is a senior leadership role within the AAT function, responsible for leading a team of scientists and interns, driving advanced analytical strategies, supporting CDMO projects, and ensuring high-quality scientific delivery aligned with global regulatory standards.

Key Responsibilities

  • Lead and manage a team of 6–10 scientists and interns
  • Plan and review team work schedules, timesheets, and deliverables
  • Represent AAT in internal governance and client meetings for CDMO projects
  • Act as PTL (Project Technical Lead), ensuring timely and accurate project execution
  • Provide technical expertise in HPLC, CE, SoloVPE including troubleshooting, data review, and interpretation
  • Contribute to method qualification (HPLC, CE, SoloVPE)
  • Review and prepare technical documents including MQP, MOA, MQR, Specifications, Analytical Similarity Studies
  • Support preparation of regulatory documents for EMA and USFDA submissions (analytical sections)
  • Prepare and review client query responses and ensure timely cross-functional communication
  • Mentor, coach, and build capabilities within the team

Technical Expertise Required

  • Advanced knowledge of HPLC-based methods: SE-HPLC, CEX-HPLC, RP-HPLC, Poly 20 measurement
  • Expertise in Capillary Electrophoresis (CE): CE-SDS (R & NR), cIEF; experience on Maurice system preferred
  • SoloVPE analysis proficiency
  • Exposure to characterization methods such as Mass Analysis, CD, Fluorescence, DSC, MALS (added advantage)
  • Experience in regulatory documentation for global agencies (EMA, USFDA) preferred

Experience & Qualification

  • M.Sc. or PhD in relevant field
  • 9+ years of experience in analytical sciences with demonstrated leadership in biotech/pharma

Soft Skills & Competencies

  • Fluent in English with strong presentation skills
  • Approachable leader with team management and conflict resolution capabilities
  • Strong cross-functional coordination skills
  • Excellent technical data review and communication skills
  • Ability to handle client-facing discussions confidently

At Enzene, you'll have the opportunity to work on cutting-edge biologics and contribute to shaping the future of global biotech.

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