FORMAULTATION HEAD

Job Description : FORMAULTATION HEAD CANADA Open to International candidates 25+ years in Pharmaceutical Formulation R&D with significant experience in Complex Generic product development, technology transfer, and regulated markets (US/EU/ROW). Ph.D. / M.Pharm in Pharmaceutics, Pharmaceutical Technology, or related discipline. Lead formulation development and commercialization of complex generic pharmaceutical products by driving scientific innovation, regulatory readiness, bioequivalence success, and cross-functional execution. The role will provide strategic leadership across formulation development, analytical collaboration, technology transfer, and external partner management while ensuring successful delivery of products for regulated markets. · Lead development of complex generic products including modified-release oral solids, topicals, injectables, ophthalmics, and advanced drug delivery systems. · Drive formulation strategies to address solubility, stability, and bioequivalence challenges. · Lead reverse engineering and characterization of reference listed drugs (RLDs) to achieve Q1/Q2/Q3 targets. · Implement Quality by Design (QbD), Design of Experiments (DoE), and PAT-based development approaches. · Collaborate closely with Analytical Development teams to resolve formulation, stability, and impurity-related challenges. · Support regulatory submissions, CTD documentation, and technical responses for global markets. · Develop bioequivalence and IVIVC-based risk mitigation strategies. · Lead technology transfer, scale-up, validation, and commercialization activities. · Manage CDMOs, CROs, and external development partners while driving project execution and scientific excellence. Complex Generic Development · Advanced Drug Delivery Systems · Reverse Engineering & Characterization · QbD / DoE / PAT · Bioequivalence & IVIVC Strategy · Regulatory & CTD Leadership · Technology Transfer & Scale-Up · CDMO & Vendor Management · Analytical Problem Solving · Scientific Team Leadership

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