MS&T

Darwinbox Digital Solutions Pvt. Ltd.; Ahmedabad District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Zydus Lifesciences is seeking an Executive/Senior Executive in Manufacturing Science & Technology (MS&T) at our Ahmedabad, Gujarat location. The role covers technology transfer, process validation, and manufacturing support across aseptic filling, vial washing, sterilization, and lyophilization, with a focus on cGMP compliance and continuous improvement.

Candidate should have B.Pharm/M.Pharm/M.Sc./B.Tech in Biotechnology or Chemical Engineering with 3–8 years of relevant sterile injectable

Qualifications

• B.Pharm / M.Pharm / M.Sc. / B.Tech Biotechnology/Chemical Engineering
• 3 to 8 years of experience in sterile injectable manufacturing
• Experience in process validation and manufacturing support preferred

Responsibilities

• Coordinate new product and process technology transfer from R&D/site transfer to commercial manufacturing
• Review and prepare technology transfer documents, manufacturing instructions, risk assessments
• Support exhibit batches, engineering batches, and process qualification batches
• Prepare and review Process Validation Protocols and Reports
• Execute PPQ activities and continued process verification
• Evaluate critical process parameters and critical quality attributes
• Provide scientific and technical support to production like Compounding, Aseptic Filling, Vial Washing, Sterilization/Autoclave, Lyophilization
• Investigate process deviations and recommend corrective actions
• Participate in root cause analysis for deviations, OOS, OOT, complaints, failures
• Conduct risk assessments (FMEA, Fishbone) and CAPA effectiveness evaluations
• Prepare and review Process validation documents, technical protocols/reports, change controls, risk assessments, PQR/APR
• Ensure compliance with cGMP, USFDA, MHRA, EU GMP, WHO and others
• Identify process improvements to enhance productivity and reduce rejection rates
• Analyze process capability and manufacturing trends
• Participate in Lean Manufacturing and Operational Excellence initiatives

Education

B.Pharm

M.Pharm

M.Sc.

B.Tech Biotechnology/Chemical Engineering

Job description

R&D – ZRC|Fill & Finish, Ahmedabad, Gujarat, India

0 - 5 Years

Job Description

Position

Executive / Senior Executive – Manufacturing Science & Technology (MS&T)

Department

Manufacturing Science & Technology (MS&T)

Qualification

• B.Pharm / M.Pharm / M.Sc. / B.Tech Biotechnology/Chemical Engineering
• 3 to 8 years of experience in sterile injectable manufacturing

Key Responsibilities

• Coordinate new product and process technology transfer from R&D/site transfer teams to commercial manufacturing.
• Review and prepare technology transfer documents, manufacturing instructions, and risk assessments.
• Support exhibit batches, engineering batches, and process qualification batches.

2. Process Validation

• Prepare and review Process Validation Protocols and Reports.
• Execute Process Performance Qualification (PPQ) activities.
• Perform continued process verification and trend analysis.
• Evaluate critical process parameters and critical quality attributes.

3. Manufacturing Support

• Provide scientific and technical support to production departments such as:
  • Compounding
  • Aseptic Filling
  • Vial Washing
  • Sterilization/Autoclave
  • Lyophilization
• Investigate process deviations and recommend corrective actions.
• Support resolution of manufacturing issues and improve process robustness.
• Participate in root cause analysis for deviations, OOS, OOT, complaints, and failures.
• Conduct risk assessments using tools such as FMEA and Fishbone Analysis.
• Prepare CAPA effectiveness evaluations.

5. Documentation & Compliance

• Prepare and review:
  • Process validation documents
  • Technical protocols and reports
  • Change controls
  • Risk assessments
  • Product Quality Reviews (PQR/APR)
• Ensure compliance with cGMP, USFDA, MHRA, EU GMP, WHO, and other regulatory requirements.
• Identify process improvement opportunities to enhance productivity and reduce rejection rates.
• Analyze process capability and manufacturing trends.
• Participate in Lean Manufacturing and Operational Excellence initiatives.

Location

Location R&D – ZRC|Fill & Finish, Ahmedabad, Gujarat, India

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.

Our commitment to a positive and empowering work environment has earned us recognition as one of India's Best Workplaces in Biotechnology & Pharmaceuticals.