Title:  PROJECT MANAGER

Role Description:

This role will support projects in Biologics operational unit at Syngene.  This individual will be responsible for ensuring the projects are delivered on time, budget and quality.  This individual should be well-versed in Technology transfer, Scale-Up, Manufacturing & outsourcing scenarios of Large molecule manufacturing.

Key Responsibilities:

• Responsible for scope setting, developing roadmap, and report building
• Lead the overall execution of multiple projects, including initiation, budgeting, scheduling, monitoring, and closure according to GLP, GMP, safety, and environmental requirements.
• Ensure vital communication within the project teams (meetings, minutes, action items) and coordinates / collaborates with other departments and Customer relationship management.
• To coordinate internal resources, third parties/vendors, and multidisciplinary activities to ensure that the project deliverables are on-time, in-full, and in quantity.
• Follow up and track all the actions coming from the PMO project meeting while tracking lessons learned.
• Handle project risks and strategic influencing to maintain project timelines
• Create and maintain comprehensive project documentation
• Responsible for weekly and monthly reports by partnering with all the stakeholders to collect and analyze data and structure weekly/monthly reports for final submission.
• Effectively apply PMI methodology and enforce project management standards.

Educational Qualification:  

• Masters in life sciences, with a background in large molecules (Biological) process development and manufacturing like Biosimilars, antibodies, Biotherapeutics, etc., or Master’s in Business administration with project management experience in the Biopharma industry.
• PMP certification or six sigma/Prince 2/ Agile certifications.

Technical/ Functional Skills:

• Must possess full fluency in MS Office (Word, Outlook, PowerPoint) with knowledge of using Microsoft Project (MS Project, Primavera) to monitor, control, and provide overall visibility to the organization.
• Knowledge of manufacturing (process, equipment, facility, automation) & quality (GLP, cGMP, 21 CFR Part 11 validation, etc.). Good understanding of product development lifecycle.
• Knowledge of Quality Assurance, CAPA, Change Control, Document Control, Training Systems
• The operational excellence attitude is critical as projects and processes in the Biologics operating unit need PM to coordinate cross-functional resources in Operations, Quality, and other supporting functions.
• Strong oral and written communication skills