The role will interface with a holistic Manufacturing Science & Technology (MSAT) team. The experienced team will handle all facets of project introduction, tech transfer, R&D, process development, engineering batch as well as GMP manufacturing (as opposed to hand-over and silos of particular functions).
You will need a positive attitude, a sharp intellect, a strong appetite for learning and an entrepreneurial ethos.
Is this you?
- Act as the key contact for clients interfacing with the business from initial project scoping through to final handover
- Execute best project management practices for CMC activities
- Establish, document, track and communicate timelines, objectives, deliverables and budgets
- Coordinate and prioritize multiple parallel projects
- 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 during company build.
- A minimum BSc or equivalent in Biological Sciences, Bioengineering, or an associated discipline
- A PMP or equivalent certification is advantageous
- Experience of managing CDMO/CTO relationships and projects
- Working knowledge of US/EU regulatory requirements
- Excellent interpersonal skills
- Outstanding organizational skills
- Excellent written and oral communication skills
- Ability to operate in a fast-paced, multi-disciplinary corporate environment
SPECIFIC SKILLS AND EXPERIENCE
They are looking for leaders and game-changers with a high level of scientific fluency and a strong commercial acumen. They need the ability to flip between interpreting a Nature paper, devising a new purification paradigm, preparing a strategy presentation for a customer and running a rig.
Scientific: PhD in Life Sciences with research experience. Experience with DSP challenges around AAV/viral vector Manufacture is highly regarded. Knowledge on the challenges of CMC for biologics is essential.
Manufacturing: Very highly regarded but suitable candidates without GMP experience will be considered. An understanding of scaling is especially sought after.
Commercial: At least two years in a high-performing business setting e.g. Biotechnology Operations, CDMO, GMP or Commercial R&D.