Project Manager (Pharma Tech Transfer/New Product Launch Management)

You will be responsible for developing detailed tech transfer project plans with milestones, timelines, budgets, and resource allocation. Your role will involve leading the transfer of products from R&D to commercial scale or site-to-site transfers. Additionally, you will oversee end-to-end launch project management, ensuring cross-functional coordination and stakeholder management. Your expertise in risk management will be essential as you identify project risks and bottlenecks, creating effective mitigation plans. Furthermore, you will play a crucial role in commercial launch readiness by supporting the first commercial batch release, coordinating artwork, pack material availability, and ensuring RM/PM readiness.

Key Responsibilities:

• Develop detailed tech transfer project plans with milestones, timelines, budgets, and resource allocation
• Lead the transfer of products from R&D to commercial scale or site-to-site transfers
• Oversee end-to-end launch project management
• Ensure cross-functional coordination and stakeholder management
• Identify project risks and bottlenecks, and create mitigation plans
• Support first commercial batch release, coordinate artwork, pack material availability, and ensure RM/PM readiness

Qualifications Required:

• B.Pharm / M.Pharm / M.Sc / MBA preferred
• PMP certification preferred

In addition to the above responsibilities, you will be required to ensure readiness of TT dossier, BMR/BPR, specifications, SOPs, and validation protocols. You will manage change controls, deviations, CAPA, and risk assessments while ensuring compliance with cGMP, WHO-GMP, EU GMP, US FDA, MHRA, and CDSCO requirements. Your technical transfer activities will include process mapping and gap assessment, equipment fitment review, trial batches/exhibit batches/engineering batches, process validation/PPQ batches, analytical method transfer, and stability study initiation.

Furthermore, you will need to track approvals from Central Drugs Standard Control Organization and export agencies, ensuring that license variations, artwork approvals, and submissions are completed. The preferred candidate should have 10-15 years of experience in pharmaceutical manufacturing/technical services/project management, preferably with experience in oral solids, injectables, hormones, oncology, sterile, or regulated market products. Exposure to CDMO/site transfer/global launches is desirable.

Skills Required:

• Strong project management skills
• GMP/regulatory understanding
• Tech transfer lifecycle knowledge
• MS Project/Excel/ERP/SAP knowledge You will be responsible for developing detailed tech transfer project plans with milestones, timelines, budgets, and resource allocation. Your role will involve leading the transfer of products from R&D to commercial scale or site-to-site transfers. Additionally, you will oversee end-to-end launch project management, ensuring cross-functional coordination and stakeholder management. Your expertise in risk management will be essential as you identify project risks and bottlenecks, creating effective mitigation plans. Furthermore, you will play a crucial role in commercial launch readiness by supporting the first commercial batch release, coordinating artwork, pack material availability, and ensuring RM/PM readiness.

Key Responsibilities:

• Develop detailed tech transfer project plans with milestones, timelines, budgets, and resource allocation
• Lead the transfer of products from R&D to commercial scale or site-to-site transfers
• Oversee end-to-end launch project management
• Ensure cross-functional coordination and stakeholder management
• Identify project risks and bottlenecks, and create mitigation plans
• Support first commercial batch release, coordinate artwork, pack material availability, and ensure RM/PM readiness

Qualifications Required:

• B.Pharm / M.Pharm / M.Sc / MBA preferred
• PMP certification preferred

In addition to the above responsibilities, you will be required to ensure readiness of TT dossier, BMR/BPR, specifications, SOPs, and validation protocols. You will manage change controls, deviations, CAPA, and risk assessments while ensuring compliance with cGMP, WHO-GMP, EU GMP, US FDA, MHRA, and CDSCO requirements. Your technical transfer activities will include process mapping and gap assessment, equipment fitment review, trial batches/exhibit batches/engineering batches, process validation/PPQ batches, analytical method transfer, and stability study initiation.

Furthermore, you will need to track approvals from Central Drugs Standard Control Organization and export agencies, ensuring that license variations, artwork approvals, and submissions are completed. The preferred candidate should have 10-15 years of experience in pharmaceutical manufacturing/technical services/project management, preferably with experience in oral solids, injectables, hormones, oncology, sterile, or regulated market products. Exposure to CDMO/site transfer/global launches is de