Associate Project Manager, CMC, Late Phase, Toronto Remote
POINT Biopharma, Canada

POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN CANADA.

Location of work

The position will be working remotely with the anticipation of travel for team and client meetings. Our business requirements are to work to accommodate Eastern Time Zone. To work in synergy, it is preferred that our applicants can work Eastern Time Zone to accommodate team and client meetings.

Overview

Reporting to the Project Manager, CMC, Late Phase, the Associate Project Manager, Chemistry Manufacturing amp; Controls will assist with the planning and management of internal and external vendor activities for the execution of late phase clinical and commercial projects whilst adhering to budget, scope and schedule requirements for POINT Biopharma. This position would also require liaison with internal project teams from various departments, such as Regulatory Affairs, Operations, Manufacturing, Logistics, Quality Control and Quality Assurance.

Responsibilities

Lead project management efforts through successful planning with diverse teams:

• Prepare and maintain project plans, obtaining management approval and project team buy-in; liaising with external vendors as appropriate.
• Facilitate logistics both internally and with external vendors; routinely monitor status and communicate as required.
• Analyze actual performance against the plan and make adjustments consistent with plan objectives. Facilitate cross-functional project team meetings with internal and external stakeholders.
• Develop, track, and monitor project goals in accordance with CMC strategy; ensure project goals are cascaded as actionable tasks and subsequently executed upon.
• Make best use of modern communication techniques as you excel at working in a virtual remote global setting.
• Maintain project documentation to promote engaging project team environment, including document management (Sharepoint), taking minutes, updating project timelines, etc.
• Able to comprehend business processes in application to external vendor relationships, including management of purchase orders, invoices etc. in collaboration with Finance.

Analyze projects’ performance:

• Direct liaison with internal and external stakeholders (e.g., CMO, vendors, and collaborators) for related projects in CMC.
• Maintain and develop tools and processes to assist in project tracking and execution.
• Assist in the delivery of data analyses, reports, summaries, and presentations; provide status updates for ongoing projects.
• Communicate proactively with stakeholders and management regarding project risks, delays, and high-impact tasks, along with proposed mitigation plans.
• Establish and publish clear priorities among project activities.
• Manage multiple concurrent projects with aggressive and challenging timelines; successfully prioritize workload in accordance with business goals.

Identify improvement opportunities:

• Possess project management expertise to effectively partner with stakeholders to ensure project management plans (and their various components) are created and maintained with aim to be catalytic in achieving the project goals.
• Consult and contribute to POINT’s Project Management knowledge and processes.

Requirements

• BS in a related field
• CAPM or working towards certification is considered an asset
• Certification or expertise in Lean, Six Sigma, or Agile is considered an asset
• Functional knowledge of GMPs and applicable Health Canada, FDA, EMA, ICH, PDA amp; ISPE Guidelines
• 3+ years of relevant working experience in the pharmaceutical/biotechnology industry in clinical phase operations, radiopharmaceutical preferred
• 1+ years of project management experience
• Experience with Asana, JIRA, MS Project, and/or similar project management tool(s)
• Organized and systematic approach to prioritization
• Ability to work independently and be an engaged team member in a dynamic, fast-paced and lean environment<

Job Rewards and Benefits