Biocon Biologics
Location
Bangalore | India
Job description
About the company:
Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated ‘pure play’ biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives. Key Responsibilities: Lead & keep oversight independently all aspects of the clinical trial supplies for assigned clinical trials. Evaluation and Selection of vendors/service providers for clinical trial supply management. Oversee set up of IxRS tools, monitor the supply utilization, optimization, resupply, accountability, re-conciliation throughout the trial and destruction processes completed after trial completion. Forecast clinical (Investigational and comparator, other Products) and ancillary (non-drug product) supply requirements. Calculate clinical supply requirements and provide the requirements to internal team for supply readiness proactively. Oversee the procurement of comparator and any additional drug products as required for clinical trials with necessary documents. Co-ordinate and review the packaging & labelling activities including design of Product labels and expiry extension if any and oversee the label design and approval processes. Liaise with internal functions of Biocon and external partners and providers (CRO, others) in driving the clinical supplies shipments and monitor the temperature excursions accordingly. Create or update SOPs required for clinical trial supply management. Experience : 6-12 Years Pharma background exposure is mandatory.Job tags
Salary
