CMC Project Manager
il y a 5 jours
We're hiring on behalf of our partner, a growing early-stage biotech developing an innovative sustained-release drug delivery platform, as they advance their lead program towards IND submission and early clinical development.
They are seeking a CMC Project Manager with a strong oral solid dosage (OSD) formulation background, ideally in modified or sustained-release systems. This is a technically involved role where the successful candidate will act as a key interface between formulation development, process scale-up, analytical activities, and external manufacturing partners. The position offers significant technical ownership within a small, collaborative and science-driven environment.
Key Responsibilities
Lead CMC project management activities for a sustained-release oral solid drug product, including formulation development, process development and scale-up to GMP manufacture.
Work closely with external CDMOs and CROs to guide formulation development, process optimisation, and manufacturing readiness.
Provide technical oversight of OSD formulation activities, including excipient and polymer-based release systems, and ensure alignment between development strategy and manufacturing constraints.
Coordinate CMC activities with nonclinical and regulatory work streams in preparation for clinical submission.
Profile
PhD or equivalent experience in pharmaceutical sciences, formulation, or related field.
Strong hands-on experience in oral solid dosage formulation, with exposure to modified or sustained-release systems (tablets, mini-tablets, multiparticulates or similar).
Experience supporting process development, scale-up and early clinical GMP manufacturing.
Experience working with and managing external development and manufacturing partners.
Comfortable working in a small, evolving biotech environment with strong on-site collaboration.
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