CMC Technical Lead (M/F/D)
Company: EPM Scientific Agency
- Location: Munich, Germany
- Seniority: Director
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
My client is a fast-growing biopharma company in Munich. They focus entirely on chronic pain. After more than eight years of R&D, their lead product was approved in Europe this year. It's a first-in-class, non-opioid treatment for chronic pain. US approval is next, and the aim is to make it the leading chronic pain therapy by 2030.
It's a lean, ambitious business that moves quickly. Leadership is a mix of entrepreneurs, ex-consultants and experienced industry people. You get real responsibility from day one.
The role
You'll own CMC end to end, from starting material to finished drug product, and lead a small team. There are two sides to it:
- Building the CMC strategy for a US NDA
- Supporting the approved product in Europe, including commercial manufacturing and lifecycle changes
What you'll do
- Set and drive the CMC strategy across development and commercial phases
- Own drug substance and drug product development: formulation, process, analytical control, specifications and stability
- Lead the CMC sections of clinical and regulatory submissions, and work with Regulatory Affairs on health authority questions
- Manage CMOs/CDMOs, including tech transfers, milestones and technical discussions
- Assess technical and supply risks and put the right mitigations in place
- Manage process and method changes and variations across the product lifecycle
- Lead and develop a team of two
- Report progress, risks and decisions to project teams and senior leadership
What they're looking for
- A degree in pharmacy, chemistry, biotech, chemical/process engineering or similar
- One of these two backgrounds:
- 4-5+ years in CMC at a pharma or biotech company
- A management consulting background with a scientific grounding
- A good understanding of how CMC, RA, QA and clinical fit together
- A practical, hands-on, common-sense approach. You can take something complex and turn it into clear next steps.
- Biotech or smaller company experience is a plus, but not essential
Desired Skills and Experience
CMC, Biotech, Biotechnoloyg, Biopharma, Pharma
