Great job opportunity for Inviting candidates for Ph.D, M.Pharm, MSc as Deputy Manager / Manager at Zydus Lifesciences- Apply before 10th February 2024

Zydus lifesciences

Website Zydus Lifesciences

About Zydus Lifesciences

“After a transformative journey of growth spanning 27 years as Cadila Healthcare Ltd. and the Zydus Group, we have adapted to the changing times. Our commitment to healthcare and life in all its dimensions, with a legacy of over 70 years, is reiterated in our new mission, vision, and purpose. As part of this evolution, we are unifying ourselves under the Zydus name. Consequently, Cadila Healthcare Ltd. is now renamed as Zydus Lifesciences Ltd.”

Job Post: Deputy Manager / Manager

Biopharmaceutics and Clinical Development (Formulation R&D) – Pharmaceutical Technology Centre, Ahmedabad

We are currently seeking qualified and experienced candidates for the positions of Deputy Manager / Manager in Biopharmaceutics and Clinical Development (Formulation R&D) at our Pharmaceutical Technology Centre in Ahmedabad.


  • M.Pharm / PhD / M. Sc. in Pharmacology and Toxicology
  • 5-10 years of experience in clinical and preclinical development for Formulation R&D

Responsibilities at Zydus Lifesciences:

Clinical and Preclinical Development of 505(b)(2) Products:

  • Conduct literature searches focusing on preclinical and clinical development programs.
  • Define the rationale for unmet needs in identified products.
  • Demonstrate a thorough understanding of disease physiology and preclinical safety pharmacology.
  • Identify appropriate CROs for non-clinical Proof of Concept (POC), Toxicity, safety pharmacology studies, PK/PD studies in humans, and bioequivalence/bioavailability studies.
  • Develop budgets for preclinical and clinical studies.
  • Author and review study plans, protocols, scientific justifications, and publications for non-clinical studies.

Review and Regulatory Submission:

  • Review data from preclinical POC, bioavailability, and bioequivalence studies, leading discussions with cross-functional teams and CROs.
  • Author and review clinical and non-clinical sections in IND, briefing packages, investigator’s brochures, and NDA for regulatory submission.
  • Monitor preclinical and clinical studies in India and overseas CROs.
  • Oversee local regulatory application submissions and approvals.

Genotoxicity/Toxicity Studies:

  • Oversee all technical and regulatory aspects of AMES test (in vitro, in vivo tissue distribution studies) and toxicity studies.
  • Review study data, study reports, and define strategies for genotoxicity/toxicity study assessments following USFDA, ICH, and OECD guidance.
  • Manage budget and financial aspects of CROs.

Additional Information:

  • Experience Required at Zydus Lifesciences:

    5-10 years

  • Qualification Required at Zydus Lifesciences:

    M.Pharm / PhD / M.Sc

  • Location:


  • Industry Type:

    Pharma/ Healthcare/ Clinical Research

  • Functional Area:

    Biopharmaceutics and Clinical Development (Formulation R&D) for Pharmaceutical Technology

  • End Date:

    10th February 2024

Please submit your application by the specified deadline. We look forward to welcoming dynamic individuals to join our team in advancing healthcare through innovative biopharmaceuticals.

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