02 Oct
|
TopGear Consultants
|
Sambhajinagar
02 Oct
TopGear Consultants
Sambhajinagar
-Program Manager-Biologics
Job Title: Program Manager Biologics
Function: Biotech Research & Development
Candidate must have experience in Biologics/ Biopharmaceuticals program management.
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
- Solid 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
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