Jobdescription
Our client, an innovative biotech company operating on a lean, virtual structure in Basel, is seeking a highly autonomous Analytical Chemist Responsible Person for an urgent 6-month mission.
This is a 100% desk-based / virtual oversight role. The company has no internal laboratory facilities. You will not perform hands-on lab work, but will entirely manage external partners and data.
Key Responsibilities:
- CDMO Oversight: Act as the primary analytical responsible person for the tracking, troubleshooting, and weekly management of external CDMOs (including managing technical transfers).
- Phase-Appropriate Strategy: Define and execute analytical strategies according to ICH guidelines for both Drug Substance (API) and Drug Product from preclinical through Phase I/II programs.
- Data & Documentation: Review and evaluate raw HPLC / MS data coming from external partners. Author and review quality documentation, method validation protocols, stability studies, and release records.
- Cross-functional Collaboration: Work closely within a flat structure alongside Process Chemists to ensure seamless project advancement.
Requirements:
- Core Scientific Expertise: Deep professional background strictly in Small Molecules / Synthetic Chemistry (API and Final Product).
- Education: PhD with 4–7 years of industry experience, or MSc with 6–10+ years of experience in the pharmaceutical or biotech sector.
- CDMO Management: Minimum of 2 years of direct, hands-on experience in outsourcing, tech transfer, and managing external contract manufacturing organizations (CDMOs/CROs).
- Technical Data Review: Strong proficiency in evaluating HPLC / MS data and phase-appropriate validation protocols without needing laboratory access.
- Soft Skills & Availability: High level of independence, excellent communication skills in English (100% fluency required), and immediate availability to start.
