Iksuda Therapeutics is a Biotechnology Company focused on the development of Antibody Drug Conjugates (ADCs) for the treatment of cancer.
An exciting opportunity to join our team as a Project Manager, CMC is now available. The CMC Project Manager is responsible for cross-functional alignment of CMC activities leading to clinical development of antibody-drug conjugates targeting oncology indications. This individual will work closely with senior management and technical leads to create project plans, track progress against key milestones and integrate projects within the program portfolio.
Essential Functions and Duties:
- Management of external vendors and coordination with the internal subject matter experts to ensure documentation and related activities are completed on time
- Tracking and managing invoicing from external vendors ensuring they are aligned with pre-agreed proposals or agreements
- Tracking and management of key inventories both internally and external vendor inventory
- Manage the supply chain of key materials to facilitate manufacturing campaigns
- Building and maintaining complex project plans
- Ensuring effective and timely communication to team members and senior management regarding project status, key milestones, achievement of external and internal commitments and resource allocation
- Managing meetings including scheduling, agendas, minutes, and actions
- Driving cross-functional alignment to facilitate decision-making
- Identifying strategic or operational issues impacting plan execution and working with the team on risk mitigation
- Facilitating effective relationships among key team members
Experience required
3 years of relevant experience in program management in pharmaceutical or biotechnology drug development specifically within the area of CMC.
Skills and competencies required
Essential
- Excellent documentation skills
- Extremely well-organized with the ability to manage a highly-detailed workflow in the context of a broad strategic perspective
- Self-motivated with expertise in both planning and implementation
- Enthusiasm for working in a dynamic environment with a sense of urgency and aggressive timelines
- Able to communicate effectively at all levels with internal employees and external collaborators, and with the ability to work collaboratively as a member of cross-functional and global team
- Proficiency in project management, resource planning, and organizational skills
- Competency with project management tools such as Microsoft Project
- Ability to independently prioritize according to the business needs and be accountable for program/project execution
- Ability to coordinate with other groups to identify and mitigate CMC program risks
- Ability to manage external relationships with key vendors and contract manufacturing partners
- Excellent written and presentation skills
Desirable
- Experience in advancing oncology drug candidate from preclinical through Phase 1 and 2 clinical trials would be preferred
- Understanding of GMP manufacturing, bio-analytics, CMC, QC/QA, and Regulatory considerations
Qualifications required
Essential
- BSc in chemistry, biology or equivalent
Desirable
- MSc in chemistry, biology or equivalent
- Project management qualifications such as APM, AXELOS etc
Schedule:
- Monday to Friday - Flexible hours
Work Location:
- This is a hybrid role, predominantly working remotely with the flexibility to attend site meetings at the Company’s UK office as appropriate with visits to the US facilities and vendor sites as required.
MUST have UK Right to Work.
Please include a cover letter with your application.
Pay: £42,000.00-£48,000.00 per year
Benefits:
- Company events
- Company pension
- Free flu jabs
- Health & wellbeing programme
- Life insurance
- Sick pay
- Work from home
Work Location: Hybrid remote in Newcastle upon Tyne NE4 5BX
