Senior Executive – Drug Product Manufacturing / Technology Transfer

Biocon Biologics Limited; Bengaluru; On-site; INR 500,000 - 700,000; Full time

Job summary

HypTechie in Bengaluru is seeking a Senior Executive to support drug product development, technology transfer, process validation, and regulatory compliance. You will prepare and review technical documentation, monitor processes, and contribute to CPV and continuous improvement in line with cGMP and QMS.

The role requires 1–3 years in pharma manufacturing or tech transfer, a B.Sc. in Life Sciences or related field, and strong analytical and documentation skills, plus comfort working with

Qualifications

• B.Sc. in Life Sciences, Biotechnology, or related discipline.
• 1–3 years of experience in pharmaceutical / biopharma manufacturing, process development, or technology transfer.
• Knowledge of cGMP, QMS, and regulatory requirements.
• Experience in process validation, CPV, and technology transfer documentation.
• Strong analytical, documentation, and problem-solving skills.
• Ability to work effectively in cross‑functional teams and during audits/inspections.

Responsibilities

• Prepare & review study-related documents for Water run, Development, IMPD/Clinical, Process Validation, Scale-up, and Continuous Improvement studies.
• Ensure equipment reliability prior to development, clinical, and process validation batches.
• Perform trending and monitoring of CQAs/CPPs to ensure product quality and control process drift.
• Draft and review SOPs for Technology Transfer of drug products and Drug-Device Combination Products.
• Provide technical inputs for Shipping Validation activities.
• Ensure cGMP compliance during product introduction to manufacturing facilities.
• Manage QMS elements including Change Control and CAPA.
• Act as Department Training Coordinator (DTC) and ensure training compliance.
• Support development, clinical studies, process validation, and scale-up batches with execution and technical inputs.
• Collaborate with Regulatory Affairs by providing process-related data for filings and addressing queries during inspections.
• Prepare documentation for new product/process technology transfer, risk assessment, and facility fit assessments.
• Develop Continued Process Verification (CPV) protocols, analyze data, and prepare CPV reports.
• Collect data for APQRs, stability OOT limits, and audit-related documentation.
• Prepare and review MFRs (Master Formula Records) and BMRs (Batch Manufacturing Records).
• Represent process functions during audits and regulatory inspections.
• Perform data analysis and coordinate experiments for process robustness, productivity improvements, and troubleshooting.
• Identify and implement process improvements in collaboration with manufacturing operations.

Skills

Analytical skills

Documentation skills

Regulatory knowledge

Cross-functional collaboration

Audits/inspections experience

Education

B.Sc. in Life Sciences / Biotechnology or related field

Job description

Location: Bengaluru

Department: Manufacturing / Technology Transfer / Process Development

Experience: 1–3 Years

Qualification: B.Sc. (Life Sciences / Pharmacy / Biotechnology or related field)

Role Summary

We are seeking a highly motivated Senior Executive to support drug product development, technology transfer, process validation, and regulatory compliance. This role involves preparation and review of technical documentation, process monitoring, regulatory support, and execution of process improvement studies, ensuring alignment with cGMP, QMS, and global regulatory standards.

Key Responsibilities

• Prepare & review study-related documents for Water run, Development, IMPD/Clinical, Process Validation, Scale-up, and Continuous Improvement studies.
• Ensure equipment reliability prior to development, clinical, and process validation batches.
• Perform trending and monitoring of CQAs/CPPs to ensure product quality and control process drift.
• Draft and review SOPs for Technology Transfer of drug products and Drug-Device Combination Products.
• Provide technical inputs for Shipping Validation activities.
• Ensure cGMP compliance during product introduction to manufacturing facilities.
• Manage QMS elements including Change Control and CAPA.
• Act as Department Training Coordinator (DTC) and ensure training compliance.
• Support development, clinical studies, process validation, and scale-up batches with execution and technical inputs.
• Collaborate with Regulatory Affairs by providing process-related data for filings and addressing queries during inspections.
• Prepare documentation for new product/process technology transfer, risk assessment, and facility fit assessments.
• Develop Continued Process Verification (CPV) protocols, analyze data, and prepare CPV reports.
• Collect data for APQRs, stability OOT limits, and audit-related documentation.
• Prepare and review MFRs (Master Formula Records) and BMRs (Batch Manufacturing Records).
• Represent process functions during audits and regulatory inspections.
• Perform data analysis and coordinate experiments for process robustness, productivity improvements, and troubleshooting.
• Identify and implement process improvements in collaboration with manufacturing operations.

Educational Qualifications & Skills

• B.Sc. in Life Sciences, Biotechnology, or related discipline.
• 1–3 years of experience in pharmaceutical / biopharma manufacturing, process development, or technology transfer.
• Knowledge of cGMP, QMS, and regulatory requirements.
• Experience in process validation, CPV, and technology transfer documentation.
• Strong analytical, documentation, and problem-solving skills.
• Ability to work effectively in cross‑functional teams and during audits/inspections.