Executive/ Senior Executive For Drug Substance Manufacturing

Ipca; Pithampur; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Ipca in India is seeking an Executive/Sr.Executive with 5–9 years of experience in biotech/pharma to lead upstream and downstream processing within a GMP environment.

You will monitor equipment and process parameters, perform vial revival, seed propagation, chromatography, and TFF steps, and ensure accurate cGMP documentation, including BMRs, logbooks, and SPRs. Collaboration with Engineering, QC, and QA is essential to maintain product quality and regulatory compliance.

Qualifications

• Experience in upstream and downstream processing in pharma manufacturing.
• Knowledge of GMP and regulatory documentation.
• Ability to draft and update GMP SOPs and BMRs.
• Collaborate with Engineering, QC and QA teams.

Responsibilities

• Execute upstream processing steps including bioreactors operations.
• Perform downstream processing such as chromatography and filtration.
• Maintain cGMP documentation and batch records (BMR, logbooks).
• Adhere to GMP guidelines and quality systems.
• Coordinate with cross-functional teams to support manufacturing.

Skills

GMP compliance

cGMP documentation

SOP drafting

Quality Assurance

Troubleshooting

Cross-functional collaboration

Education

M.Sc / M.Tech / B.Tech (Biotech / Biochemistry)

Tools

Bioreactors

Single-use bioreactors

Chromatography systems

TFF systems

Autoclaves

Filtration systems

Job description

Experience: 05-09 Years

Designation: Executive/Sr.Executive

Qualification:M.Sc/M.Tech/B.Tech (Biotech/Biochemistry)

Role & responsibilities :

USP

• Execute upstream processing operations, ensuring process consistency, product quality, and adherence to GMP guidelines and quality systems.
• Monitor equipment and process parameters to maintain consistency, reporting any abnormal observations or deviations to supervisors.
• Performupstream processing activities, including vial revival, seed propagation, Media & Feed preparation, Bioreactors operation, and clarification process.
• Manage and submit cGMP documentation, including logbooks, batch manufacturing records (BMR) andother GMP documents, maintaining up-to-date, accurate records.
• Collaborate with cross-functional teams, including Engineering, Quality Control (QC), and Quality Assurance (QA), to support manufactuing
• Draft and update Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Standard Process Records (SPRs), and other GMP documents, supporting compliance and accuracy.
• Operate, manage & perform troubleshooting of all USP equipments, including RM,single-use bioreactors, depth filtration systems, pallet tanks, autoclaves, and IPQC equipment.

DSP

• Execute Downstreamprocessing operations, ensuring process consistency, product quality, and adherence to GMP guidelines and quality systems.
• Monitor equipment and process parameters to maintain consistency, reporting any abnormal observations or deviations to supervisors.
• Performing Downstreamprocessing activities, including Chromatography, Virus inactivation, TFF, Virus removal, Buffer and solution preparation.
• Performing Resolute Column packing activity using Packing station.
• Operate, manage and perform trouble shooting of DSPequipment, chromatography systems, TFF system, Buffer preparation system and other downstream processing equipment
• Review and maintenance of Logbooks on shop-floor. Manage and submit cGMP documentation, including logbooks, batch manufacturing records (BMR), andother executed documents.
• Collaborate with cross-functional teams, including Engineering, Quality Control (QC), and Quality Assurance (QA), to support manufacturing
• Draft and update Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Standard Process Records (SPRs), and other GMP documents, supporting compliance and accuracy.