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Product Development Manager
The VET Recruiter ®
The Product Development Manager will support activities with expertise in drug formulation, product manufacturing and regulatory. The Product Development Manager will provide support in managing contractors. This role provides formulation expertise and selects the most appropriate formulation for pre-clinical, clinical and commercial use. The incumbent solves problems related to formulation, supply or other drug product or drug substance challenges, leads in the outsourcing effort toward the development and manufacturing of drug product formations. The incumbent will manage drug substance and drug product logistics to ensure sufficient materials are available to support planned nonclinical and clinical studies and helps develop and manage budgets for R&D projects. The incumbent will write/review protocols for manufacturing drug products and actively participates in preparations for internal audits and regulatory inspections as necessary. The incumbent will prepare CMC sections of regulatory filings and acts as the development lead for selected products in life-cycle activities. The incumbent will provide expertise and scientific direction regarding the evaluation and selection of new product technologies, in association with cross-functional evaluations and requirements from research, clinical, commercial and regulatory teams. Qualifications include a Bachelor’s degree or higher in Pharmacy, Pharmaceutics, Chemistry, Chemical Engineering or a closely related field is required. A minimum of 3-5 years experience in the Pharmaceutical Industry including experience in formulation and process development of pharmaceutical dosage forms, familiarity with product development, clinical supplies processes, regulatory guidelines and experience in regulatory submissions (CMC Module 3) is required. Experience in working with outsourcing model is preferred.