Technical CMC Project Manager
Technical CMC Project Manager
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1 Vacancy
Job Description
Job Summary:
Mythic Therapeutics is searching for a dynamic CMC Project Coordinator/ Project Manager to join our growing Technical Operations team. This candidate will use their scientific expertise and program management skills to coordinate late phase project team in the progression of prevalidation and validation activities from locking CQAs (critical quality attributes) and control strategy through BLA submission.
This individual will have a solid scientific/technical background ideally in the development of ADC therapeutics. They are energized by working in an entrepreneurial scientifically rigorous and resultsoriented culture. The candidate is expected to be a leading champion of crossfunctional communication aligning priorities for optimal project execution while demonstrating the ability to manage and lead teams in drug development projects. This position will report to the Director of CMC Project Management.
Key Responsibilities and Opportunities:
- Coordinate a latephase project team in prevalidation and validation activities
- Work closely with the technical team and CDMOs to execute validation strategy.
- Oversee CDMO ensuring CMC deliverables are timely robust and complete
- Track project milestones report progress and keep stakeholders informed.
- Formulate plans for risk mitigation and scenario planning for potential challenges.
- Ensure timely communication of plans progress and issues to CMC leadership
Minimum Requirements
- Must have a degree in a scientific/engineering discipline BS/BASc with at least 5 years MS/MASc with at least 3 years or a PhD with at least 1 years and drug development experience in the pharmaceutical industry.
- A leader with outstanding program management skills and a history of developing winning project teams and team cultures in biotech/biopharma.
- Proficiency in cGMP and other relevant global regulatory requirements.
- Proficiency in facilitating meetings and drafting presentation materials.
- Excellent organizational communication and analytical skills with a keen attention to detail.
- Outstanding interpersonal skills to form and maintain strong relationships.
- Willingness and dedication to go above and beyond in pursuit of team goals.
- Advanced PowerPoint SmartSheet and MS Project skills.
- Experience managing/overseeing outsourced CMC activities highly desirable.
- Able to view issues from multiple functional perspectives. Ability to work collaboratively and crossfunctionally with research and development technical operations clinical regulatory and finance is critical to success in this role.
- Familiarity with CMC technical processes and the overall drug development process.
- Possesses a business/operations mindset and experience in using metrics scientific/technical data competitive intelligence and advanced analytics to support decision making.
Location: Hybrid 3 days in the office and 2 days remote
Employment Type
Full Time
