Designation - Deputy Manager
Job Description: Team member – In vitro In vivo toxicology.
- Key Responsibilities: Experimental Toxicology & Preclinical Research
- Develop preclinical strategies supporting differentiated product development.
- Plan, outsource, oversee, and interpret in vitro and in vivo preclinical toxicology and pharmacokinetics/pharmacodynamics (PK/PD) studies for NCE or complex/differentiated products, vaccines, biological products
- Plan, outsource, oversee, and interpret impurity qualifications studies.
- Plan, outsource, oversee, and interpret in vivo/ in vitro genotoxicity studies.
- Plan, outsource, oversee, and interpret in vivo/ in vitro biocompatibility studies for medical devices.
- Plan, outsource, oversee, and interpret in vitro immunogenicity studies for peptides and biosimilar products.
- Summarize toxicological data and prepare Investigational Brochures (IBs), Investigational New Drug (IND) applications, and electronic Common Technical Document (e-CTD) for regulatory authority submissions.
Qualifications and Skills
- Advanced degree in Toxicology, Pharmacology, Zoology, Veterinary Medicine or related field.
- Minimum 7-10 years of experience in experimental toxicology within the pharmaceutical, CRO or biotechnology industry.
- Strong understanding of regulatory guidelines (e.g., ICH, USFDA, EMA, CFDA, DCGI) and experience with regulatory submissions.
- Proven ability to manage multiple projects simultaneously and work effectively in a dynamic team environment.
- Excellent communication skills with the ability to collaborate cross-functionally and interact with external partners such as CROs.
- Detail-oriented with proactive planning abilities, coupled with strong analytical skills, effective timeline management, adept problem-solving capabilities, and excellent collaboration and teamwork skills.
- Skilled in using computer software including Microsoft Office suite (Word, Excel, PowerPoint), SharePoint, QSAR tools, data mining software, citation tools, and other relevant applications.
Operational details:
- Location: Vikhroli, Mumbai.
- Mode: Full time, work from office
- Shifts: General shift (8 hours)
- Travelling: Rare/Occasional for outdoor duties/ monitoring
