Cipla, a global pharmaceutical leader, is renowned for its dedication to innovation, quality, and affordability in healthcare solutions. Headquartered in Mumbai, Cipla offers an expansive portfolio of products spanning therapeutics, biologics, and medical devices. With a strong commitment to patient-centric care, Cipla fosters an environment of growth, collaboration, and innovation.
Responsibilities in the Job
As a Toxicologist / Preclinical Scientist, you will play a pivotal role in developing and executing preclinical strategies for differentiated product development. Your key responsibilities will include:
- Designing and managing in vitro and in vivo toxicology, pharmacokinetics/pharmacodynamics (PK/PD), and genotoxicity studies.
- Planning and interpreting biocompatibility studies for medical devices.
- Conducting immunogenicity evaluations for peptides and biosimilar products.
- Preparing critical documentation, including Investigational Brochures (IBs) and IND applications for regulatory submissions.
- Ensuring compliance with global regulatory guidelines like ICH, USFDA, EMA, CFDA, and DCGI.
Qualifications Required
To excel in this role, candidates must possess:
- An advanced degree in Toxicology, Pharmacology, Veterinary Medicine, Zoology, or a related discipline.
- 2-5 years of experience in toxicological risk assessment and experimental toxicology in the pharmaceutical, CRO, or biotechnology industries.
- A strong understanding of regulatory guidelines and submission protocols.
- Proficiency in tools like Microsoft Office, QSAR tools, data mining software, and citation tools.
Skills Required
- Exceptional analytical and planning capabilities to manage multiple projects effectively.
- Strong communication and collaborative skills for cross-functional teamwork and external partner interactions.
- Attention to detail with a proactive approach to problem-solving.
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