Senior Manager - Production (Downstream) - DS Biologics Plant

About the company

USV is a long-established healthcare organisation with 58 years of experience. It started as a joint venture with USV&P Inc., USA, which was a subsidiary of Revlon. The company’s portfolio spans active pharmaceutical ingredients, fixed-dose formulations, peptides, biosimilars, and injectables, all produced in cGMP-compliant facilities in India.

Role overview

This position is for a Senior Manager in Production, focused on downstream operations at a drug substance biologics manufacturing plant in Navi Mumbai. The facility is microbial in nature and operates under approvals from EMA, MHRA, ANVISA, SFDA, and Health Canada. The role leads a team of 18 and reports to the Head of Production for Upstream and Downstream operations.

Key responsibilities

• Oversee day-to-day downstream manufacturing activities and ensure execution follows approved procedures and current cGMP requirements.
• Create and manage batch schedules for downstream processing.
• Drive cost optimisation by reviewing process needs and supporting alternate vendor development.
• Investigate recurring failures, identify root causes, and put systems or procedures in place to reduce repeated deviations.
• Track equipment performance over time and initiate preventive actions before breakdowns occur.
• Ensure preventive maintenance, calibration, and validation are completed on schedule and that batch planning stays aligned with timelines.
• Maintain uninterrupted availability of raw materials and packing materials in line with business plans.
• Keep the downstream area and its documentation continuously inspection-ready.
• Monitor downstream activities for possible data integrity risks and simplify procedures where needed to make recording easier and more robust.
• Review downstream records for technical accuracy and compliance with site procedures.
• Examine deviations, change controls, CAPA actions, and other quality system records.
• Review MFRs, BMRs, SOPs, protocols, reports, and related process documentation.
• Ensure EHS policies are followed and that work in the manufacturing area remains compliant with current norms.
• Monitor team performance and provide guidance to ensure smooth daily operations.
• Coordinate closely with QC, QA, Engineering, Supply Chain Management, Purchase, Safety, and other stakeholders.
• Partner with R&D on development batches and new projects.

Eligibility

Applicants should hold a B.Tech/B.E. in Biochemistry or Biotechnology, or a B.Sc. in Microbiology or Biotechnology.

Additional information

Team size: 18

Reporting line: HOD - Production (Upstream & Downstream)

Plant details: Drug Substance Biologics Manufacturing Plant

Facility type: Microbial

Regulatory approvals: EMA, MHRA, ANVISA, SFDA, Health Canada