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Biocon - Manager - Lab Management R&D Biologics
2 weeks ago
Overview:.
About the organization:.
Biocon Biologics is a fully-integrated 'pure play' biosimilars organisation 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 - rst 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.
Key Responsibilities.
- Managing reference drug product and in-house biosimilar product throughout the entire lifecycle for pipeline biosimilar programs and SKUs.
- This includes tasks such as vendor qualification, receipt, tracking storage, distribution, and disposal.
- Preparing, reviewing and revision of Standard Operating Procedures (SOPs), annexures and related documents pertaining to reference product management.
- Maintaining stability chambers housing the reference and in-house products & logbooks and collaborating with instrumentation and maintenance team (and vendors) in case of any storage system failures.
- Participate and articulate comprehensively about reference product management in R&D, in internal (quality, risk and compliance) and external regulatory audits (e.g.USFDA), as required.
- Liaison with IT, various R&D functional teams, R&D QA, SCM and operations effectively in managing and updating inventory of reference product.
Key Technical Skills -.
- Familiarity with eLN/LIMS would be a plus.
- Good oral and written communication.
- Flexible, Agile and ability to multi-task.
- Education Graduate or Post Graduate in Biotechnology or Equivalent.
- Work Experienceof 15 plus years.
- Work Location Bangalore.
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