Research And Development
2 months ago
At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe.
About the Role:
Cell Culture Lab Role ( Upstream) :The candidate as cell culture expert is expected to possess the following technical/functional skills:
- Should possess technical expertise in
- Process development
- Process scale up & tech transfer
- Scale down model development & process characterization
- Has experience in risk management strategies, adoption of newer technologies for upstream functional activities
- Prepare technical documents, updates to senior management and manage the cell culture operations for enabling routine activities
- Abilities to seamlessly work with multiple cross functional teams to deliver on program timelines
- Ability to use statistical tools and skilled in data analysis
Key responsibilities:
- Lead teams in cell culture for robust process development and tech transfer.
- Accountable for technical leadership to complete project goals in a timely manner
- Responsible for hiring, training and building cell culture team
- Manage lab operations – Inventory management, equipment management and project budgets
- Ensure adherence of the team to compliance as per organizastional requirements
- Support manufacturing, MSAT, Quality teams in tech transfer, life cycle management and investigations
- Appropriate support for regulatory dossier preparation, filing, review and audits
- Ensure adherence to robust documentation practices in compliance to ALCOA principles
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