Sr. Project Manager - Radiopharmaceutical

The Sr. Project Manager – Radiopharmaceutical Business Objectives will be responsible to lead business-critical projects at our ATLab Indianapolis site.

In addition to managing projects, this role will play a key part in ensuring that the facility and process design are aligned with CMC development and regulatory requirements, particularly for the IND submission, upcoming Phase III clinical studies, NDA submission, and FDA Pre-Approval Inspection (PAI).

The Sr. Project Manager will report to Director of Operations, NA. This role requires strong leadership in project management, but also the ability to partner with Quality, Regulatory, CMC, and Manufacturing teams to ensure the facilities and processes meet clinical and commercial readiness expectations.

Key Responsibilities

Partner with CMC, Quality, Regulatory Affairs, Safety, and Manufacturing teams to ensure the site is poised to support clinical trial and commercial production requirements.

Coordinate all projects pertaining to technology transfers, new product introductions, and Phase III/commercial production.

Anticipate regulatory and validation requirements for both clinical and commercial supply, ensuring our site is inspection ready.

Develop mitigation plans for risks and gaps in project execution.

Drive the governance, knowledge management, and continuous improvement for projects linked to Phase III and commercial production.

N/A, The Sr. Project Manager – Radiopharmaceutical Business Objectives will be responsible to lead business-critical projects at our ATLab Indianapolis site.

In addition to managing projects, this role will play a key part in ensuring that the facility and process design are aligned with CMC development and regulatory requirements, particularly for the IND submission, upcoming Phase III clinical studies, NDA submission, and FDA Pre-Approval Inspection (PAI).

The Sr. Project Manager will report to Director of Operations, NA. This role requires strong leadership in project management, but also the ability to partner with Quality, Regulatory, CMC, and Manufacturing teams to ensure the facilities and processes meet clinical and commercial readiness expectations.

Key Responsibilities

Partner with CMC, Quality, Regulatory Affairs, Safety, and Manufacturing teams to ensure the site is poised to support clinical trial and commercial production requirements.

Coordinate all projects pertaining to technology transfers, new product introductions, and Phase III/commercial production.

Anticipate regulatory and validation requirements for both clinical and commercial supply, ensuring our site is inspection ready.

Develop mitigation plans for risks and gaps in project execution.

Drive the governance, knowledge management, and continuous improvement for projects linked to Phase III and commercial production., N/A