Executive – Downstream

[Exp: 2 to 5 years]

We are looking for an experienced and detail-oriented professional to support downstream operations in a Bulk Manufacturing (BM) facility for small molecule API production. The role involves equipment handling, documentation, compliance, and coordination with cross-functional teams to ensure efficient and cGMP-compliant manufacturing processes.

Key Responsibilities:

· Facility readiness, monitoring, and routine maintenance; ensure operational efficiency of key equipment including mixing vessels, centrifuges, AGR, GLR, SSR.

· Participate in shift operations to support continuous manufacturing activities for small molecule APIs.

· Prepare, review, and maintain process-related documentation including MFRs, BPRs, SOPs, protocols, and other downstream process documents; ensure timely submission and closure.

· Good understanding in chemical engineering concepts like Extraction, Distillation, TFF, Column chromatography, Centrifugation, Filtration, Drying

· Manage Quality Management System (QMS) activities, including initiation and closure of change controls, deviations, and CAPAs related to bulk manufacturing.

· Track and manage inventory of raw materials and consumables used in the manufacturing process.

· Adhere to and promote safety protocols and proper use of PPE within the bulk manufacturing environment.

· Support the scale-up and execution of development batches in coordination with R&D

· Coordinate with the engineering team and external vendors to track and complete preventive maintenance and calibration activities for downstream equipment and instruments.

· Ensure compliance with Good Documentation Practices (GDP) and cGMP standards in all facility and process operations.

· Liaise with vendors for equipment and instrument qualification, troubleshooting, and resolution of technical issues related to downstream processes.

· Collaborate with internal stakeholders and actively participate in technical and safety training to ensure seamless production operations.

Preferred candidate profile

· Expertise in handling aseptic operation and critical equipment’s in downstream process.

· Ensure compliance with quality management systems.

· Must have knowledge on GDP, GMP practices during batch operation in commercial campaign.

· Must have work experience in manage the team

Industry Type: Pharmaceutical & Life Sciences

Department: Production, Manufacturing

Employment Type: Full Time, Permanent

Education: Diploma/B.Tech/MSc/ in Chemistry/Chemical

Job Type: Full-time

Pay: ₹10,000.00 - ₹25,000.00 per month

Benefits:

• Provident Fund

Ability to commute/relocate:

• Pondicherry, Puducherry: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Pharmaceutical: 3 years (Required)
• Life science: 3 years (Required)
• Analytical chemistry: 3 years (Required)
• Chemical engineering: 3 years (Required)

Work Location: In person