Biocon Biologics is a fully-integrated ‘pure play’ biosimilars organization globally committed towards transforming patient lives through innovative and inclusive healthcare solutions. It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led-global biopharmaceuticals company and India's first publicly listed biotech enterprise. Biocon Biologics has one of the largest biosimilars portfolios, a wide global footprint, state-of-the-art manufacturing facilities, world-class R&D ecosystem, and high quality & compliance standards, enabling it to fulfil unmet needs of patients across the globe.
Role Details:
- Resource need to have knowledge of Pharmaceutical drug product development and Regulatory guidelines
- Design studies and supervise formulation and process design space experiments in the lab.
- Liaise with Manufacturing/Quality/Regulatory departments
- Budget and resource management
- Responsible for development and upskilling of junior members
- To ensure documentation and interpret the scientific data.
- Introduction/exploration of new methodologies for inclusion into the Lab, modifying existing processes so as to make the lab functioning and or development activities more efficient and less time consuming
- To ensure documentation of the findings as per in-house SOP for documentation.
- Communicate with Program teams and project teams on the requirements for studies, and timelines, timeline constraints
- Interface with production/quality teams as and when need arises for study execution.
- Interacting with other cross functional teams to communicate and convey results
- As required, support drafting of Scientific Advice, dossier sections, responses to Regulatory Agency queries.
- Review of documents drafted by junior members of the function
- Preparation and review of cross-functional documents such as TTD, BMR, PV protocols etc
- Responsible for execution and oversight of Third-party activities.
- Review and closure of reports and electronic Lab notebooks
- Technical and operational support for team and day-to-day operations
- Review and approval of QMS Track-wise and DMS activities.
- Data/Statistical analysis using Scientific applications such as JMP, Minitab, Graphpad etc.
Ameliorating/advancing formulation and drug product development aspects – bringing in new technologies, improvement of existing procedures, institutionalize existing knowledge for use across programs etc.
Post-graduate with 12 plus years of experience or PhD with up to 10 years of experience in biopharmaceutical industry. Life sciences background in biochemistry, biotechnology, protein chemistry or allied subjects preferred.