Title
Freelance Regulatory CMC Consultant
Location
Remote (Italy and travelling to UK Sites twice in a year)
Commitment
Minimum 50% time (Iterative, deadline-driven)
Company Overview
Apsida Life Science is currently partnering with a clinical-stage biotech based in Turin, Italy, developing inhaled peptide therapeutics for respiratory diseases and oncology.
Responsibilities
Directly author and own CMC regulatory submissions, including IMPDs, INDs, and CTAs. This requires hands‑on writing of dossiers and scientific documents, not just oversight.
CDMO Management: Act as the primary point of contact for external CDMOs, managing day‑to‑day operations, project schedules, and budgets for Drug Substance (DS) and Drug Product (DP).
Supply Chain & Logistics: Partner with Clinical Operations to project DS/DP needs and manage the end‑to‑end supply chain to support preclinical and clinical studies.
Technical Review: Lead the review of critical process documentation, including batch records, protocols, CoAs, specifications, deviations, and change controls.
Strategic Planning: Identify and select CDMOs for development, optimization, and scale‑up across the company portfolio.
Cross‑functional Integration: Align CMC project management with non‑clinical and clinical development functions to ensure information flow and compliance with cGMP standards.
Qualifications
BSc, MSc, or PhD in Life Sciences.
7–10+ years in Biotech, Pharma, or CDMO environments within a CMC/Analytical function.
Essential experience in sterile liquid formulation development, specifically targeting shelf‑stable presentations.
Proven experience drafting and submitting IMPDs/INDs and navigating tech