Quick Overview
Job Description
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.
KEY RESPONSIBILITIES
- Own end-to-end IT leadership for the Pharma Manufacturing & R&D Sites covering IT Operations, Digital Manufacturing, Automation, Smart Labs and OT systems.
- Act as the primary technology partner to Site Leadership, Manufacturing, R&D, and Engineering teams.
- Drive Industry 4.0, Smart Factory, Smart Labs, and IoT initiatives across shop-floor, labs, warehouses and utilities.
- Ensure reliable, secure and compliant operation of core manufacturing systems including MES, LIMS, DCS, SCADA, Historian and Serialization.
- Lead digital transformation programs focused on predictive maintenance, real-time analytics, AI/ML use cases and paperless manufacturing.
- Ensure full compliance with GxP, Data Integrity (ALCOA+), CSV, and regulatory expectations (USFDA, EMA, MHRA, etc.).
- Manage site IT budgets, vendors, system integrators and technology partners.
- Build and mentor high-performing site IT and automation teams with strong succession planning.
- Collaborate with Global IT, Architecture and Digital teams to align site initiatives with enterprise standards.
YEAR ONE CRITICAL SUCCESS FACTORS
- Stabilize and standardize all critical manufacturing and R&D systems at the site.
- Define a Digital roadmap for Manufacturing & R&D IT inline with functional goals and strategies.
- Deliver at least 3-5 high-impact Industry 4.0 / IoT use cases with measurable business value.
- Leverage use of AI and ML in Batch manufacturing, automation and predictive maintenance.
- Improve system availability, data integrity and audit readiness across the site.
- Establish a robust IT/OT governance framework with high security.
- Build strong credibility and trust with Site Leadership and Global IT stakeholders.
PROFESSIONAL EXPERIENCE / QUALIFICATIONS
- Bachelor's or Master's degree in Engineering, Technology or related discipline.
- 22+ years of experience leveraging Information Technology, Digital, IoT and Industry 4.0 in large-scale manufacturing environments.
- Minimum 10+ years in Pharma / Life Sciences manufacturing with strong exposure to regulated systems.
- Proven leadership experience managing complex IT, Automation and OT landscapes at manufacturing sites.
- Deep understanding of MES, DCS, SCADA, LIMS, Historian, Serialization and Cloud-based analytics platforms.
- Strong experience in regulatory inspections, audits and remediation programs.
- Excellent stakeholder management, communication and executive presence.
- Ability to operate strategically while remaining hands-on when required in a plant environment.
Skills
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