CMC Program Manager - Innovative Gene Therapy Start Up
Reporting to: Associate Director CMC Program Management
The CMC Program Manager will play a direct role in planning, budgeting, integrating, tracking and communicating CMC activities for the Company’s product development programs. This will include working with internal stakeholders, academic partners and the Company’s designated Contract Manufacturing Organizations (CMOs).
- Implement best project management practices for CMC activities
- Establish, document, track and communicate CMC timelines, objectives, deliverables and budgets
- Lead cross-functional project team meetings and drive on-time completion of deliverables
- Facilitate problem-solving, contingency planning, and decision-making
- Ensure linkage between strategy and operational activities
- Co-ordinate cross-functional communication and integration
- Other activities as may be assigned
The ideal candidate for this position will have demonstrated experience of integrated program/project management in the biotech/pharma industry.
Candidate must possess:
- A minimum BS in Biological Sciences, Bioengineering, Chemistry or an associated discipline
- Experience in the biotechnology or pharma industry with a primary focus on project/program management of CMC related activities
- Solid understanding of biological product development phases
Education & skills
- Experience managing CMO/CTO relationships and projects
- Working knowledge of US and European regulatory requirements
- Excellent interpersonal skills
- Outstanding organizational skills
- Excellent written and oral communication skills
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
- Travel to US and international CMO and CTO sites may be required
Platinum Healthcare Coverage, Dental and Vision, 401 (k) Safe Harbor Plan, Life Insurance and more including competitive Salary, Bonus and Equity scheme (role dependent).