Deputy Manager/Assistant Manager-Process Development ( Downstream )

Zydus Healthcare Limited; Ahmedabad District; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Zydus Lifesciences is seeking a Deputy Manager/Assistant Manager-Process Development (Downstream) in Ahmedabad. You will plan and supervise DSP activities for diverse vaccine candidates, designing purification strategies and ensuring quality through robust processes.

You will lead technology transfer, collaborate with multiple functions, and drive regulatory and QMS compliance while mentoring junior staff and managing inventories and equipment maintenance.

Responsibilities

• Plan, supervise laboratory-scale and pilot-scale DSP activities for bacterial, recombinant, and viral vaccine candidates.
• Design and optimize purification steps including filtration, chromatography, UF/DF, conjugation, inactivation, and formulation.
• Analyze data, interpret results, and provide recommendations to support development and troubleshooting.
• Lead technology transfer and scale-up from R&D to pilot and commercial manufacturing.
• Coordinate with Upstream, Analytical, Formulation, QA, QC, Manufacturing, Regulatory, and Supply Chain for timely project execution.
• Prepare and review development reports, PDRs, protocols, risk assessments, and technical presentations.

Skills

DSP Development

Process Development

GMP Compliance

Tech Transfer

Scale-Up

Data Analysis

Team Leadership

Job description

Deputy Manager/Assistant Manager-Process Development ( Downstream ) VTC R&D R&d - Ptc Ahmedabad|vtc-ahmedabad, Ahmedabad, Gujarat, India 8 - 15 Years

Job Description

JOBDISCRIPTION

Job Responsibilities: Deputy / Associate Manager -Vaccine R&D (DSP)

1. Plan,execute, and supervise laboratory-scale, pilot-scale, and process developmentactivities related to downstream processing (DSP) of bacterial, recombinant,and viral vaccine candidates.

2. Designand optimize purification processes involving filtration, chromatography,ultrafiltration/diafiltration (UF/DF), conjugation, inactivation, andformulation to achieve target product quality and yield.

3. Analyzeexperimental data, interpret results, and provide scientific recommendations tosupport process development, process optimization, and troubleshootingactivities.

4. Leadtechnology transfer and process scale-up activities from research anddevelopment to pilot and commercial manufacturing while ensuring processrobustness and reproducibility.

5. Coordinateeffectively with cross-functional teams including Upstream Process Development,Analytical Development, Formulation Development, Quality Assurance, QualityControl, Manufacturing, Regulatory Affairs, and Supply Chain to ensure timelyproject execution.

6. Prepareand review technical documents including development reports, processdevelopment reports (PDRs), risk assessments, protocols, and technicalpresentations for internal and external stakeholders.

7. Supportregulatory submissions by preparing scientific justifications, CMCdocumentation, dossier sections, responses to regulatory queries, andprocess-related data packages.

8. Driveimplementation of Quality Management System (QMS) requirements, ensuringcompliance with applicable GMP, GLP, regulatory guidelines, and companyprocedures.

9. Reviewand approve SOPs, BMRs, protocols, reports, change controls, deviations, CAPAs,risk assessments, and other quality documents related to process developmentactivities.

10. Ensureavailability of raw materials, consumables, resins, chemicals, standards, andreagents required for uninterrupted execution of development activities.

11. Managelaboratory inventories and material consumption, ensuring proper stock control,storage conditions, and timely procurement.

12. Overseemaintenance, calibration, qualification, and operation of laboratory andpilot-scale equipment in accordance with cGMP and EHS requirements.

13. Ensurecompliance with Environmental Health and Safety (EHS) policies, promoting astrong safety culture and ensuring safe laboratory practices.

14. Leadroot cause investigations, troubleshooting activities, and continuousimprovement initiatives to enhance process performance, productivity, andproduct quality.

15. Assessand implement new technologies, purification platforms, and process innovationsto improve development efficiency and manufacturing capabilities.

16. Train,mentor, and supervise scientific staff and junior team members, ensuringcompetency development, knowledge sharing, and high-performance teamwork.

17. Supportproject planning, resource allocation, and milestone tracking to ensure timelyachievement of development objectives.

18. Ensuresuccessful execution of vaccine development programs from proof-of-conceptthrough process validation and commercialization stages.

• Chromatography andFiltration Technologies
• Viral and RecombinantVaccine Purification
• Technology Transfer andScale-Up
• GMP & RegulatoryCompliance
• Data Analysis and ScientificReporting
• Project and Team Management
• Risk Assessment and ProblemSolving

Job Snapshot

Updated Date

27-08-2026

Job ID

JOB11023

Division

VTC R&D

Location

At Zydus Lifesciences, w e nurture a culture of innovation, excellence, and inclusivity , driving meaningful advancement in the pharmaceutical and healthcare industries. Fueled by creativity , we constantly exploring new ways to improve patient care and expand healthcare accessibility.