Manager Lab Management R&D Biologics

1 month ago

Bengaluru, India Biocon Biologics Full time

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 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.



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 Experience- of - 15 plus years

Work Location - Bangalore

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