CMC Project Manager

JOB TITLE: CMC Project Manager

DEPARTMENT: Project Management

TYPE: Full Time

REPORTS TO: Senior Project Manager

SUMMARY OF RESPONSIBILITIES:

The CMC Project Manager is responsible for providing project management support to all aspects of the CMC activities at Aptose, ensuring each project is defined and executed with the best project management practices.
The CMC Project Manager will collaborate with internal personnel, SMEs and external CMOs’ Project Managers for timelines, method development, process, storage/inventory management, and logistics. This individual is also responsible for tracking CMC budgets and assisting with regulatory filings.

PRIMARY RESPONSIBILITIES:

  • Manage integrated CMC timelines across all programs
  • Work closely with internal CMC team and CMOs to ensure all CMC deliverables and activities are aligned with corp. objective
  • Coordinate all CMC sub-team meetings, documenting minutes and managing action items
  • Implement the CMC project strategy
  • Identify potential risks and risk management strategies
  • Coordinate with CMC technical team to maintain CMC dashboards
  • Ensure that CMC timelines and dependencies align with the overall master project plan
  • Inventory management for all CMC samples, standards, final bulk drug substance and drug product
  • Collaborate with CMOs to ship samples, API, drug product.
  • Collaborate with QA and technical team to ensure batch release on time
  • Provide CMC budget forecast
  • Assist CMC regulatory fillings

REQUIRED EDUCATION & WORK EXPERIENCE:

  • PhD in Science w/ a minimum of 4 years biotech/pharma industry experience, OR
  • MS in Science w/ a minimum of 6 years biotech/pharma industry experience, OR
  • BS in Science w/ a minimum of 8 years biotech/pharma industry experience
  •  PMP certificate or equivalent is a plus

PREFERRED QUALIFICATIONS:

  • Previous experience with small molecules strongly preferred
  • Minimum of 5 years in the technical drug development role, such as analytical, formulation, process engineering, quality,
  • Minimum of 2 years in CMC project management role
  • Experience project planning and project team management
  • Experience in risk identification and mitigation
  • Experience CMO management is a plus
  • Ability to work independently (with minimal supervision) in a fast-paced team environment.

FUNCTIONAL / TECHNICAL KNOWLEDGE & SKILLS:

  • Proficient in Microsoft Office (Word, Excel, Power Point and Project) and Smartsheet
  • Knowledge of cGMP requirements for pharma / biotech industry
  • Drug Development
  • Regulatory Environment
  • Process, Procedures and Best Practices

COMPETENCIES

  • Attention to details
  • Collaborate
  • Communicate effectively in English, both oral and written
  • Deliver on commitments
  • Detail oriented and meticulous follow through
  • Maintain composure
  • Organizational skills
  • Proactively plan and organize
  • Solve problems
  • Adapt
  • Be self-aware
  • Manage and improve process
  • Facilitate
  • Influence and persuade
  • Lead

TRAVEL REQUIREMENTS:

  • As needed

If you are interested in above position, please send your resume and cover letter to Jobs@Aptose.com