Program Managers/ Project Managers - Increasing needs in Biotech Pharma world

Hi Project management graduates I am writing this post to bring everyone attention toward increasing needs of project /program managers in biotech and pharma world.

Why there is a growing demand:-

1.New research and development with increase in pipeline of clinical products 

2.Process optimization and need to commercial scale manufacturing as FDA approval of clinical products are increasing

3.Process transfer , manufacturing facility expansion 

What project manager / program manager do:-

Regulatory project / program manager :- responsible for leading the project from regulatory perspective for example CTA , INd filing coordination. Bringing cross functional departments SME together. Content plan , kickoff meeting, routine change control meeting, publishing meeting.

Pharmaceutical/ GMP program manager : manage projects related to GMP manufacturing such as commissioning qualification of new facilities, process transfer, technology transfer, supplier oversight, specification revision team

Clinical program project manager: manage clinical site initiatives, clinical inspection, Site initiation, shipment of CTm, interaction with team to ensure smooth clinical trial.

Pipeline / Project / program manager:

These manager work with leadership to ensure company clinical pipeline is moving smoothly. Updating leadership on milestones and bringing attention toward key challenges if any. Work collaboratively with cross functional colleagues ensuring timeline accomplishments of tasks.

Quality program manager/ Product quality lead :- these manager work closely with CMo to ensure they are qualified and have validated process. All documents required to proceed for manufacturing are completed. For all clinical and commercial products respective markets authority are notified and documentation are compliance. MSA and QTA are approved with all new suppliers , CMO and Test labs

Education, experience and skills needed:-

All project manager needs either a degree in project manager or atleast a certification 

All project manager should know tools like MS office , MS project, Budgeting, Cross functional department, basic knowledge of regulatory approval process and timelines

This is a very rewarding field and can help various companies excel their product pipeline to next level by helping many needed patients.