A.M/Dy.M/Manager - MS & T(Injectables)

Digvijaya Management; Hyderabad; On-site; INR 15,00,000 - 25,00,000; Full time

Job summary

A leading management firm in Hyderabad is seeking an experienced professional with B.Pharmacy/M.Pharmacy and 8-10 years in Manufacturing Science. The role includes leading technology transfers, optimizing processes, and providing technical support in a regulated injectable manufacturing environment. Strong analytical and documentation skills are essential.

Qualifications

• 8-10 years of experience in Manufacturing Science and Technology.
• In-depth knowledge of aseptic/sterile injectable manufacturing processes.
• Familiarity with cGMP, ICH, USFDA, EU GMP guidelines.

Responsibilities

• Lead tech transfer of injectable formulations from R&D to manufacturing.
• Evaluate and optimize manufacturing processes for yield and quality.
• Provide on-the-floor technical support during manufacturing.

Skills

Manufacturing Science and Technology

Analytical Skills

Problem-solving Skills

Documentation Skills

Education

B.Pharmacy/M.Pharmacy

Tools

Statistical Tools

Six Sigma

Job description

Candidate should be B.Pharmacy/M.Pharmacy with 8-10 years of experience in Manufacturing Science and Technology from a reputed Injectable Industry for regulated markets.

Technology Transfer

• Lead tech transfer of injectable formulations from R&D to manufacturing.
• Collaborate with formulation development, QA, QC, production, and engineering teams.
• Prepare and review technology transfer documents (TT protocols, reports, BMRs, etc.).

Process Optimization

• Evaluate and optimize manufacturing processes for yield, cost, and quality improvements.
• Analyse critical process parameters (CPPs) and critical quality attributes (CQAs).
• Drive scale-up and process robustness studies.

Process Validation

• Support the preparation and execution of process validation protocols (PV).
• Review and interpret process data for validation outcomes.
• Address any deviations, CAPAs, and improvement plans.

Troubleshooting and Technical Support

• Provide on-the-floor technical support during manufacturing.
• Investigate and resolve process-related deviations and batch failures.
• Conduct root cause analysis and implement preventive measures.

Continuous Improvement

• Identify and implement process improvements and cost-saving initiatives.
• Utilize tools like QbD, DOE, FMEA, and Six Sigma for problem-solving and process enhancement.
• In-depth knowledge of aseptic/sterile injectable manufacturing processes (lyophilization, terminal sterilization, SVP/LVP, etc.).
• Familiarity with cGMP, ICH, USFDA, EU GMP guidelines.
• Strong analytical and problem-solving skills.
• Good documentation and communication skills.
• Experience with statistical tools and data analysis is a plus.