India

To be an integral part of an antibody development team with a focus on performance and specificity using innovative molecular, protein, and cell biology methods.

The Clinical Research Lead will oversee and manage clinical research activities within the organization. This role involves designing, implementing, and monitoring clinical trials to ensure they meet regulatory requirements and organizational goals.

Provide strategic guidance and expertise in oncology for the development and execution of medical affairs plans focusing on Lung Cancer, GU Cancers and Hematology portfolio. Collaborate with cross-functional teams to support the successful launch and commercialization of oncology products.

Familiarity with high-performance organizational tools and a strong understanding of digital manufacturing processes, computer system validation requirements, and quality management within biologics production and quality.

Ensure on time analysis of Finished products and raw materials for required product and projects. Review of analytical data, raw data, daily usage logbooks and Lab notebooks for routine operations for analytical development function. Preparation and review of critical documents like Analytical Method validation protocol, reports, Analytical method transfer protocols and reports.

Bachelors degree in life sciences or business. Experience in consulting management in the life sciences, pharmaceutical/ biotech consulting industry or equivalent industry role

Offers leadership and basic accountability, provides strategic assistance, and planning support for clinical regulatory documents. Writers and edits clinical regulatory documents, including submission summaries and other complex documents.

First class in M.PHARM or M.S in Pharmaceutics, drug delivery, Pharmacology, Pharm-Biotechnology, Nanomedicines, or equivalent from a recognized University. As per BITS RMIT PHD program eligibility.

The Manager Drug Safety Content Analysis will manage and supervise project’s PV Operations/training staff on a day-to-day basis, guiding performance of PV Operations staff in ongoing projects in terms of training, quality of deliverables, compliance with the timelines and relevant trainings.