Product Development Manager, CMC

Product Development Manager, CMC

The Product Manager, CMC, ensures timely development of products that meet the standards of regulatory authorities to support animal drug applications for a broad range of dosage types.  The Product Development Manager, CMC will be the CMC technical lead for all CMC aspects and/or lead one or more global development projects in research and development through all stages required to obtain regulatory approval for sale in global markets.  This role requires management of outside resources, leadership of project teams as well as being the technical lead in a multidisciplinary project team  The Product Development Manager, CMC works closely with the internal-partners in various functions as well as external and contract manufactures and labs to ensure the products meet the expectations of multiple regulatory authorities as well as the company’s Product Development goals and standards. The incumbent will partner with technical experts to review and create technical documents that when submitted to authorities will result in a comprehensive review. Technical experts include Pharmaceutical Development, Regulatory, Quality and Manufacturing. The Product Development Manager will provide technical expertise and leadership in the field of pharmaceutical product development, technical transfer, scale up and validation.

Qualifications include a Bachelor’s, Master’s Degree or PhD in a relevant field, ie, chemistry, Pharmaceutical Sciences, 5-10 years of pharmaceutical product development experience with increasing level of  (Project) leadership responsibility. Proven track record in at least one area of product development-CMC (API, formulation, analytical methods, process development or cGMP manufacturing), working knowledge of pharmaceutical products including tablets, capsules, parenteral or semisolids, understanding of method validations, stability testing, process validation, quality assurance, strong organization and problem solving experience, in depth knowledge of regulatory requirements including FDA, EMEA, VICH/ICH regulations, demonstrated technical leadership experience.

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