program manager

TopGear Consultants Pvt Ltd.; Chhatrapati Sambhajinagar District; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

TopGear Consultants Pvt Ltd is seeking an experienced Program Manager Biologics to lead complex Biologics R&D programs, coordinate timelines, and ensure regulatory documentation alignment at the R&D Centre in Chhatrapati Sambhajinagar.

The ideal candidate will manage cross-functional teams, track progress in ASANA, maintain trackers, and coordinate with vendors and reference products to keep programs on schedule.

Qualifications

• Experience in Biologics/Biotech R&D program coordination.
• Familiar with regulatory documentation and development workflows.
• Proficiency with ASANA, Excel, and project tracking tools.
• Strong coordination, communication, and follow-up skills.

Responsibilities

• Track and coordinate Biologics R&D project activities, timelines, follow-ups, and status updates.
• Manage ASANA updates, BPR coordination, and activity tracking for Development Teams.
• Coordinate regulatory documentation activities including Form 29, CT-11, and CT-16 applications.
• Support stage-gate documentation readiness, query resolution, and reference product coordination.
• Maintain project trackers, license updates, reports, and vendor coordination activities.
• Coordinate with reference products with all stakeholders and vendors and maintain a tracker.

Skills

Biologics R&D coordination

ASANA

MS Excel

Project tracking

Education

M.Pharm / M.Sc (Biotechnology, Microbiology, Biochemistry, Life Sciences) / B.Tech or M.Tech (Biotechnology)

Tools

ASANA

MS Excel

Job description

Job Description-Program Manager-Biologics

Candidate must have experience in Biologics/ Biopharmaceuticals program management.

Job Title

Program Manager Biologics

Function

Biotech Research & Development

Experience Required

6 to 10 Years

Location

R&D Centre, Chhatrapati Sambhajinagar

No of positions

01

Job Summary

We are looking for an experienced Program Manager Biologics to manage project coordination, timelines, regulatory documentation and program tracking activities within Biotech R&D.

Key Responsibilities

Track and coordinate Biologics R&D project activities, timelines, follow-ups, and status updates

• Manage ASANA updates, BPR coordination, and activity tracking for Development Teams
• Coordinate regulatory documentation activities including Form 29, CT-11, and CT-16 applications
• Support stage-gate documentation readiness, query resolution, and reference product coordination
• Maintain project trackers, license updates, reports, and vendor coordination activities
• Coordinate with reference products with all stakeholders and vendors and maintain a tracker

Required Skills & Competencies

Experience in Biologics/Biotech R&D program coordination

• Knowledge of regulatory documentation and development workflows
• Hands‑on experience with ASANA, MS Excel, and project tracking tools
• Strong coordination, communication, and follow-up skills

Educational Qualification

M.Pharm / M.Sc (Biotechnology, Microbiology, Biochemistry, Life Sciences) / B.Tech or M.Tech (Biotechnology)

Preferably additional course of project management

Preferred Candidate Profile

610 years of relevant experience in Biologics