Biocon - Manager - Lab Management R&D Biologics

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.