Process Manager – Reagents

Job Title : Process Manager – Reagents

Location : Vizag

Department : Manufacturing / Operations

Reports To : Head Manufacturing

Role Purpose :

The Process Manager – Reagents is responsible for managing and optimizing manufacturing processes for diagnostic reagents (Biochemistry, Hematology, Immunology, Molecular Diagnostics, etc.), ensuring high quality, regulatory compliance, cost efficiency and continuous improvement in production operations.

Key Responsibilities:

1. Process Management & Optimization

Oversee end-to-end reagent manufacturing processes including formulation, filling, labeling and packing.

Ensure process standardization, validation and continuous optimization.

Drive yield improvement, cycle time reduction and cost optimization initiatives.

Monitor process performance through KPIs and implement corrective actions.

2. Technology Transfer & Scale-Up

Lead technology transfer from R&D to manufacturing.

Ensure smooth scale-up of new reagent formulations with minimal deviations.

Collaborate with R&D, QA and QC for process validation and troubleshooting.

3. Quality & Compliance

Ensure compliance with regulatory standards such as ISO 13485, CDSCO, CE, FDA (if applicable).

Work closely with QA/QC teams to ensure batch release timelines and adherence to specifications.

Investigate deviations, OOS (Out of Specification) and CAPA implementation.

4. Production Planning & Execution

Align production schedules with demand forecasts and business requirements.

Ensure optimum utilization of manpower, equipment and materials.

Minimize downtime and improve overall equipment effectiveness (OEE).

5. Continuous Improvement (Lean / Six Sigma)

Lead Lean, Six Sigma, and Kaizen initiatives for process excellence.

Identify and implement automation opportunities in reagent manufacturing.

Drive digitization and data-driven decision-making in operations.

6. Team Leadership & Development

Lead and mentor a team of production engineers, chemists and operators.

Build a culture of accountability, safety and continuous learning.

Conduct training programs on SOPs, GMP and process improvements.

7. Safety, Health & Environment (SHE)

Ensure adherence to safety protocols and regulatory norms.

Promote safe handling of chemicals and biological materials.

Drive EHS initiatives and audits.

Key Performance Indicators (KPIs):

• Batch yield & process efficiency

• Reduction in deviations / CAPA closure timelines

• On-time production & delivery adherence

• Cost per batch / process cost reduction

• OEE (Overall Equipment Effectiveness)

• Audit compliance scores

Qualifications & Experience:

Education:

M.Sc. (Chemistry / Biochemistry / Biotechnology) or B.Tech / M.Tech (Chemical / Biotech)

Experience:

8–15 years in reagent / diagnostics / pharmaceutical manufacturing

Strong experience in IVD reagents (Biochemistry, Hematology, Immunology, ELISA, Rapid Kits) preferred

Exposure to regulated environments (ISO 13485, GMP)

Key Skills & Competencies

• Strong knowledge of reagent chemistry and formulation processes

• Process validation and scale-up expertise

• Lean Manufacturing / Six Sigma (Green Belt preferred)

• Problem-solving and analytical thinking

• Cross-functional collaboration

• Leadership and team management

• Knowledge of regulatory and compliance frameworks

Preferred Industry Background:

In-vitro Diagnostics (IVD)

Pharmaceuticals / Biotech

Medical Devices (Reagents segment preferred)

Behavioral Competencies:

• Result-oriented with strong execution focus

• High ownership and accountability

• Ability to work under pressure and manage complexity

• Continuous improvement mindset

Career Progression:

• Senior Process Manager

• Manufacturing Head / Plant Head

• Operations Excellence Leader