Associate Project Manager, Chemistry, Manufacturing and Controls
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.

Reporting to the Project Manager, Chemistry, Manufacturing and Controls (CMC), the Associate Project Manager is responsible for:

• Operational strategy and timely execution in managing various departments and vendors for projects in alignment with company and CMC objectives.
• Process mapping inter-departmental and inter-company communication related to CMC.
• Owning and maintaining multiple interlinked project roadmaps/ High Level Plans (HLP).
• Risk register maintenance through identification, monitoring and follow-up of risks related to CMC projects.
• Organization and structuration of CMC project related spaces and repositories.

• Continuous improvement of project management processes and/or CMC communications strategy and acts as ambassador for CMC PM processes

Objectives

• To ensure the efficient, agile, and timely completion of deliverables within CMC projects in various stages of radiopharmaceutical development with vendors, manufacturing, and clinical departments.
  
• To successfully co-ordinate work sessions to develop project scenarios and strategies with multi-disciplinary teams through timelines, budget, risk, and options analysis.
• To successfully communicate and maintain CMC HLPs and process maps.
• To successfully contribute to technical writing of CMC documents with SMEs in line with various regulatory bodies and GMP guidelines
• To successfully track and monitor all CMC project related activities.

Responsibilities

1. Facilitating the Agile SCRUM framework with project teams
2. Creating and maintaining project timelines amp; milestone trackers
3. Identifying, ranking, and mitigating risks within risk registers
4. Proposing proactive and corrective actions in accordance with radiopharmaceutical regulations
5. Creating and maintaining status and/or progress reports and presentations
6. Creating and maintaining trackers to monitor key project deliverables (action/decision/equipment/document/cost etc)

Requirements

• B.Sc/B.Eng in a related field of science/engineering.
• 3+ years experience in pharmaceutical, healthcare, food or cosmetic industry.
• Functional knowledge of GMP practices and regulations.
• Experience working with remote teams.
• Strong knowledge of digital project management tools (JIRA/Asana/Wrike etc.) is considered an asset.
• PMP/CAPM and/or CSM/LSM certification is an asset.
• Technical writing experience is considered an asset.
• Experience and knowledge with Office 365 suite including SharePoint.

Competencies

• High attention to detail, well organized, and highly motivated
  
• Excellent ability to multitask and prioritize workload
• Strong oral and written communication skills, and interpersonal skills
• Excellent planning skills with the ability to work seamlessly as part of a team or independently.
• Experience in an FDA regulated environment a plus
• Proficient in MS Excel with ability to develop and manage complex workbooks.
• Remain calm and maintain composure in a fast-paced environment.
• Operate and execute with an extreme sense of urgency

Why joining POINT today will be the right career move for you:

There

Job Rewards and Benefits