PDL/MSAT (Injectable)- Manger

Intas; Ahmedabad District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Intas is seeking an experienced professional to lead sterile injectable formulation development, technology transfer, and MSAT support. The role emphasizes process validation, risk assessment, and regulatory filings while driving continuous improvement across manufacturing suites.

The candidate should have 10-15 years of experience in injectable formulation development, PDL, MSAT, or technology transfer and hold an M. Pharm in Pharmaceutics or equivalent qualification.

Qualifications

• 10-15 years of experience in Injectable Formulation Development, PDL, MSAT, or Technology Transfer.
• M. Pharm preferred for advanced qualification.
• Experience in regulatory filings and cGMP compliance.

Responsibilities

• Lead formulation and process development activities for sterile injectable products.
• Plan and execute scale-up and exhibit batches.
• Coordinate technology transfer from R&D to manufacturing sites.
• Prepare process validation and technology transfer documents.
• Provide scientific and technical support to commercial manufacturing.
• Investigate process deviations, OOS/OOT results, and market complaints.
• Recommend CAPA and process improvement initiatives.
• Monitor process performance and product quality trends.
• Identify opportunities for yield improvement, cycle time reduction, and cost optimization.
• Perform risk assessments and statistical analysis.
• Drive continuous improvement projects.
• Support preparation of regulatory dossiers and responses.

Skills

Injectable formulation development

Sterile manufacturing processes

Process validation

Technology transfer

Scale-up studies

QbD principles

Risk assessment tools (FMEA)

Statistical data analysis

Regulatory filing support

Education

M. Pharm (Pharmaceutics)

Job description

Role & responsibilities

Product Development & Technology Transfer :

• Lead formulation and process development activities for sterile injectable products.
• Plan and execute scale-up and exhibit batches.
• Coordinate technology transfer from R&D to manufacturing sites.
• Prepare process validation and technology transfer documents.

MSAT Support :

• Provide scientific and technical support to commercial manufacturing.
• Investigate process deviations, OOS/OOT results, and market complaints.
• Recommend CAPA and process improvement initiatives.
• Monitor process performance and product quality trends.

Process Optimization

• Identify opportunities for yield improvement, cycle time reduction, and cost optimization.
• Perform risk assessments and statistical analysis.
• Drive continuous improvement projects.

Regulatory & Compliance

• Support preparation of dossiers, regulatory responses, and deficiency replies.
• Ensure compliance with cGMP, Data Integrity, and regulatory requirements.
• Participate in audits conducted by USFDA, MHRA, EMA, WHO, and other agencies.

Team Management

• Lead and mentor a team of scientists/executives.
• Plan resource allocation and project timelines.
• Drive performance, capability development, and succession planning.

Preferred candidate profile

Educational Qualification:

• M. Pharm (Pharmaceutics) Preferred

Experience

• 10-15 years of experience in Injectable Formulation Development, PDL, MSAT, or Technology Transfer.

Technical Skills

• Injectable formulation development
• Sterile manufacturing processes
• Process validation
• Technology transfer
• Scale-up studies
• QbD principles
• Risk assessment tools (FMEA)
• Statistical data analysis
• Regulatory filing support

Behavioral Competencies

• Leadership & Team Management
• Problem Solving
• Decision Making
• Stakeholder Management
• Communication Skills
• Innovation & Continuous Improvement