Senior Manager _DSP _ Microbial or Mammalian Biologics_Maharashtra

BVR People Consulting; Navi Mumbai; In loco; INR 4.000.000 - 6.000.000; Tempo pieno

Descrizione del lavoro

BVR People Consulting is seeking a Senior Manager Production (Downstream) in Maharashtra to lead day-to-day operations in a biologics manufacturing facility. You will oversee DSP, batch planning, and team management ensuring compliance with cGMP and QMS.

The role requires 16–22 years in biologics/pharma manufacturing, with at least 2 years in a team leadership position in downstream production. You will drive process improvements and coordinate with QA, QC, Engineering, Supply Chain, and R&D.

Competenze

• 16-22 years of overall experience in Biologics/ Biotechnology/ Pharmaceutical manufacturing.
• Minimum 2 years in a Team Lead / Section Head role in Downstream Production.
• Strong experience in Downstream Processing (DSP).
• Experience in Microbial and/or Mammalian manufacturing.
• Strong knowledge of cGMP and QMS.
• Hands-on experience with Chromatography, TFF/UF-DF, filtration and purification is preferred.

Mansioni

• Lead Downstream Production operations for microbial/mammalian biologics manufacturing.
• Manage batch scheduling, manpower planning and day-to-day production activities.
• Ensure compliance with cGMP, SOPs and manufacturing procedures.
• Review and manage Deviations, CAPA, Change Controls, investigations and risk assessments.
• Ensure audit readiness and maintain strong documentation compliance.
• Review BMR, MFR, SOPs, protocols and process-related documents.
• Monitor equipment performance and coordinate preventive maintenance, calibration and validation activities.
• Drive process improvement, productivity enhancement and operational cost reduction.
• Coordinate with QA, QC, Engineering, Supply Chain, Purchase, EHS and R&D.
• Ensure timely availability of raw materials and production resources.
• Support technology transfer, development batches and new product/project activities.
• Lead, mentor and develop the downstream production team.

Conoscenze

Downstream Processing

Team leadership

cGMP knowledge

QA coordination

Process optimization

Documentation

Strumenti

Chromatography

TFF/UF-DF

Filtration

Purification

Descrizione del lavoro

Greetings!!!!

We are looking for an experienced Downstream Production professional to lead day-to-day manufacturing operations in a biologics manufacturing facility.

Position: Senior Manager Production (Downstream)

Role: Section Head

Location: Maharashtra

Experience: 16- 22 Years

Industry: Biologics / Biotechnology / Pharmaceutical Manufacturing

Job Description:

The candidate will be responsible for Downstream Processing (DSP), batch planning and scheduling, production team management, process optimization and ensuring smooth execution of manufacturing activities in compliance with cGMP and QMS requirements.

Key Responsibilities:

• Lead Downstream Production operations for microbial/mammalian biologics manufacturing.
• Manage batch scheduling, manpower planning and day-to-day production activities.
• Ensure compliance with cGMP, SOPs and manufacturing procedures.
• Review and manage Deviations, CAPA, Change Controls, investigations and risk assessments.
• Ensure audit readiness and maintain strong documentation compliance.
• Review BMR, MFR, SOPs, protocols and process-related documents.
• Monitor equipment performance and coordinate preventive maintenance, calibration and validation activities.
• Drive process improvement, productivity enhancement and operational cost reduction.
• Coordinate with QA, QC, Engineering, Supply Chain, Purchase, EHS and R&D.
• Ensure timely availability of raw materials and production resources.
• Support technology transfer, development batches and new product/project activities.
• Lead, mentor and develop the downstream production team.

Key Requirements:

• 1622 years of overall experience in Biologics / Biotechnology / Pharmaceutical manufacturing.
• Minimum 2 years of experience in a Team Lead / Section Head role in Downstream Production.
• Strong experience in Downstream Processing (DSP).
• Experience in Microbial and/or Mammalian manufacturing.
• Strong knowledge of cGMP and QMS.
• Hands‑on experience with Chromatography, TFF/UF-DF, filtration and purification is preferred.
• Strong exposure to Deviations, CAPA, Change Controls, validation and audit readiness.
• Excellent team management and cross-functional coordination skill.