Education & Qualifications:
- Advanced degree in Science or Engineering
- 10 or more years of experience in the biotechnology industry including leadership roles in key Operations functions (e.g., Process Development, Manufacturing, Quality)
- Authoritative command of dealing with complexity and ambiguity; ability to collect, digest and communicate information through relevant business analyses to influence decision-making
- Advanced project management skills, including the ability to identify and execute strategic initiatives, manage multiple projects, prioritize project resources, and assess project effectiveness and efficiency
- Excellent root cause analysis training and troubleshooting skills with the ability to solve complex problems
- Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
- Experience with FDA and EMA CMC Meetings and Filings regarding cell therapy
- Demonstrated excellence and experience in the clinical and commercial development of cell therapy programs including aspects related to both CMC and regulatory requirements
- Working knowledge of GMP requirements as interpreted by FDA, EMEA, and other external regulatory bodies
- Excellent reporting and presentation skills. Ability to distill complex information to simple to understand presentations, including reporting to the Board and Shareholders.
We are firm believers that the diversity of our ideas, perspectives and people promote innovation and is one of our key strengths. Fortuna Fix cultivates employment equity and encourages applications from all groups.
If you are passionate about bringing real solutions to critical health conditions, we want to hear from you. Send us your resume at email@example.com and a real human will review it. A cover letter justifying your interest gets our relationship off to a great start!
Duties & Responsibilities:
Key responsibilities include, but are not limited to:
- Collaborate with the leadership team to identify, develop and implement plans for the operational infrastructure of systems, processes and personnel to accommodate the growth objectives of the company.
- Execute robust Risk Management practices to maintain high probability of project success, i.e., satisfaction of scope, schedule and budget.
- Ensure timelines are met and operation/project costs remain within the established budget.
- Establish key performance indicators that drive change and visibility to the team and leadership. Track, trend, and monitor routinely with active data analysis to target and drive results.
- Coordinate the development of action plans when corrective steps (CAPA) are required and implement these in a timely manner.
- Develop closed systems for manufacturing. Quality and SOP's. Regulatory Affairs for CMC. Prepare, File and review CMC Documents with FDA and EMA. Manage Process Tech transfer and oversee cell therapy manufacturing site.
- Organize and prepare documents and reporting in support of IND Filings.
- Prepare and create presentation material on status and progress of projects, company milestones, plans and projections.