Executive – Drug Substance Manufacturing (DSP Operations)
Company: Cadila Pharmaceuticals Ltd.
Location: Dholka, India
Department: Biotech – Sales & Marketing Job Category
Employment Type: Full-Time
Experience: 2–5 years of experience in Biotech/Pharmaceutical manufacturing, preferably in Drug Substance (DS) manufacturing, downstream processing (DSP), GMP operations, and vaccine production.
Salary Package: ₹4.5–8 LPA (Approx., based on current market standards; final compensation depends on candidate experience, technical expertise, and skills.)
Role Overview
The Executive – Drug Substance Manufacturing is responsible for executing downstream processing (DSP) operations for vaccine drug substance manufacturing, ensuring GMP compliance, process efficiency, batch execution, equipment management, and coordination with cross-functional teams to achieve manufacturing objectives.
Key Responsibilities
Drug Substance Manufacturing Operations
Execute DSP operations for Drug Substance manufacturing of:
Seasonal Influenza Vaccine (Cadiflu Tetra)
Rabies Vaccine (Thrabis)
Perform drug substance batch manufacturing activities as per approved procedures.
Support preparation of clinical trial material in collaboration with the R&D team.
Execute scale-up batches for vaccine drug substance manufacturing.
Troubleshoot DSP operations during manufacturing activities.
Perform in-process testing and monitor critical process parameters during batch operations.
Batch Documentation & GMP Compliance
Ensure timely completion of batch manufacturing records, logbooks, and documentation with zero errors.
Ensure compliance with GMP guidelines, SOPs, and regulatory requirements.
Execute media fill activities as per requirements.
Prepare and revise manufacturing documents (MMDs) and SOPs.
Ensure adherence to EHS (Environment, Health & Safety) standards during manufacturing operations.
Equipment Management & Validation
Perform and oversee qualification, calibration, and annual maintenance of manufacturing equipment, including:
Purification systems
Filtration systems
Filtration isolators
Other manufacturing equipment
Coordinate with engineering teams for facility management and timely closure of equipment breakdowns.
Support process validation and cleaning validation activities.
Quality Management System (QMS) & Audit Compliance
Maintain compliance with Quality Management Systems (QMS).
Support internal and external audits and ensure compliance with regulatory expectations.
Drive CAPA implementation for audit observations.
Ensure no major compliance observations through effective GMP practices.
Inventory & Material Management
Manage inventory of raw materials, consumables, and manufacturing supplies.
Ensure availability of materials for uninterrupted manufacturing operations.
Coordinate with warehouse teams for timely material movement and availability.
Cross-Functional Collaboration & Team Management
Collaborate with Quality Assurance (QA), Quality Control (QC), Engineering, Warehouse, and R&D teams.
Coordinate activities to ensure timely completion of manufacturing schedules.
Train and support new team members and manufacturing staff.
Contribute to continuous improvement initiatives within manufacturing operations.
Educational Qualification
Bachelor's or Master's degree in:
Biotechnology
Biochemistry
Microbiology
Life Sciences
Pharmacy
Related pharmaceutical disciplines
Required Experience
Experience in vaccine manufacturing, biologics, or pharmaceutical production preferred.
Hands-on experience in downstream processing (DSP) operations.
Knowledge of GMP, QMS, SOP compliance, and regulatory requirements.
Experience with batch documentation, process validation, and manufacturing equipment handling.
Technical Skills
Knowledge of biologics/vaccine manufacturing processes.
Understanding of downstream processing techniques.
Experience with GMP manufacturing operations.
Knowledge of CAPA, deviation management, and audit compliance.
Familiarity with manufacturing documentation systems.
Key Competencies
Strong technical understanding of manufacturing processes.
Good documentation and compliance skills.
Problem-solving and troubleshooting abilities.
Strong coordination and teamwork skills.
Attention to detail and quality focus.
Ability to manage multiple manufacturing activities effectively.
Strong commitment to safety and regulatory compliance.
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