Senior Executive and Assistant Manager

Biophore; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Biophore, based in Hyderabad, India, is seeking an experienced Project Manager for Formulation R&D. You will review proposals from BD/Portfolio, assess feasibility, prepare budgets and timelines, and coordinate with cross-functional teams to secure raw materials, packaging, and analytical requirements.

The role involves leading weekly reviews, developing micro-plans, tracking milestones, coordinating with SCM, QA, and RA, supporting FDA interactions, and ensuring timely dossier filings and

Qualifications

Responsibilities

• Review project proposals received from Business Development (BD)/Portfolio Teams, assess feasibility, and prepare preliminary budgets and project timelines.
• Coordinate with CFTs to finalize development quantities for raw materials (RM), packaging materials (PM), and analytical requirements to support budget preparation and project scope finalization.
• Track licensing requirements and their availability, align project timelines, and organize project kick-off meetings.
• Prepare project plans and micro-plans, track milestones, monitor progress, and ensure timely dossier filing.
• Coordinate with SCM, Purchase, and internal/external Alliance Management Teams to ensure timely availability of API, IMP, WS, and RS for development and exhibit batches.
• Conduct weekly project review meetings, prepare progress presentations, and communicate project status to stakeholders .
• Coordinate with Plant/Manufacturing Teams for the smooth execution of scale-up and exhibit batches.
• Coordinate with and support Regulatory Affairs (RA) Teams in technical documentation, ANDA submissions, and timely responses to FDA queries (IRs, DRLs, and CRLs).

Job description

Job Responsibilities

Project Management Formulation R&D

• Review project proposals received from Business Development (BD)/Portfolio Teams, assess feasibility, and prepare preliminary budgets and project timelines.
• Coordinate with CFTs to finalize development quantities for raw materials (RM), packaging materials (PM), and analytical requirements to support budget preparation and project scope finalization.
• Track licensing requirements and their availability, align project timelines, and organize project kick-off meetings.
• Prepare project plans and micro-plans, track milestones, monitor progress, and ensure timely dossier filing.
• Coordinate with SCM, Purchase, and internal/external Alliance Management Teams to ensure timely availability of API, IMP, WS, and RS for development and exhibit batches.
• Conduct weekly project review meetings, prepare progress presentations, and communicate project status to stakeholders .
• Coordinate with Plant/Manufacturing Teams for the smooth execution of scale-up and exhibit batches.
• Coordinate with and support Regulatory Affairs (RA) Teams in technical documentation, ANDA submissions, and timely responses to FDA queries (IRs, DRLs, and CRLs).