CMC Consultant

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 transfer/scale‑up.
• Direct experience with small peptide development, peptide formulation, and associated analytical methodologies.
• Deep fluency in cGMP standards, ICH guidelines, and regulatory requirements for DS/DP manufacture.
• Availability to travel to Torino once every two months for 2–4 days.
• Availability to visit manufacturing sites in Italy and the UK (twice/year).

Contact

If you are interested in learning more, please reach out to Sweetness Zono at Apsida Life Science:

+44 (0)