TitleFreelance Regulatory CMC ConsultantLocationRemote (Italy and travelling to UK Sites twice in a year)CommitmentMinimum 50% time (Iterative, deadline-driven)Company OverviewApsida Life Science is currently partnering with a clinical-stage biotech based in Turin, Italy, developing inhaled peptide therapeutics for respiratory diseases and oncology.Responsibilities
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Directly author and own CMC regulatory submissions, including IMPDs, INDs, and CTAs.
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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).
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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.
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Qualifications
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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.
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xlwpduy Availability to visit manufacturing sites in Italy and the UK (twice/year).
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ContactIf you are interested in learning more, please reach out to Sweetness Zono at Apsida Life Science: