Manager / Senior Manager Project Management

Role & responsibilities

1. Prepare detailed project timelines using tools such as Gantt charts and milestone trackers to monitor the end-to-end progress of API and intermediate projects.

2. Define critical path activities that determine the project delivery date and monitor them closely to ensure adherence to schedules.

3. Escalate risks or delays to senior management and stakeholders, and implement recovery plans to bring projects back on track.

4. Rebaseline timelines with proper approvals when there are changes in scope, resources, or regulatory requirements.

5. Coordinate with cross-functional teams including Process R&D, Production, Engineering, QA/QC, SCM, RA, and EHS to ensure timely deliverables.

6. Ensure utilities, plant modifications, and equipment readiness are completed as per project requirements.

7. Liaise with vendors and contractors to ensure on-time delivery of equipment, materials, and services needed for project execution.

8. Track progress of lab trials, pilot batches, scale-up runs, validation batches, and commercial production to meet project milestones.

9. Conduct regular project review meetings, prepare agendas, and circulate minutes of meetings for alignment and accountability.

10. Prepare dashboards, variance reports, and project updates for senior management and client review.

11. Support Regulatory Affairs in the timely preparation, review, and submission of CMC (Chemistry, Manufacturing, and Controls) documentation.

12. Ensure compliance with cGMP, ICH Q7/Q8, and other applicable global regulatory standards throughout project execution.

13. Act as the key point of contact for client communication, particularly in CDMO projects, ensuring transparent updates on progress and timelines.

14. Share periodic project status reports with clients and manage their expectations regarding deliverables and timelines.

15. Negotiate changes in commitments, deliverables, or schedules with clients as required.

16. Identify potential risks that may impact project delivery and develop proactive mitigation measures.

17. Maintain a risk register and manage change-control requests systematically.

18. Develop and standardize project management templates, trackers, and checklists to streamline project execution.

19. Capture lessons learned from completed projects and integrate them into future project planning.

Recommend process improvements to reduce overall project cycle time and enhance efficiency.

Preferred candidate profile

• B.Tech / M.Tech (Chemical Engineering), M.Sc (Organic Chemistry), or B.Pharm / M.Pharm.
• 5 to 10 years experience in API / Bulk Drugs / Intermediates project management.
• Strong knowledge of process development, scale-up, tech transfer, and validation.
• Familiar with cGMP, ICH Q7/Q8, USFDA, EMA, WHO, CDSCO guidelines.
• Experience in coordinating cross-functional teams and handling CDMO projects.
• Excellent communication, stakeholder management, and problem-solving skills
• Skilled in project planning tools such as MS Project, Excel, and other relevant project management applications.