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.
Qualifications:
- 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:
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.
