Product Development Manager
The Product Development Manager will ensure timely development of products to support animal drug applications for a broad range of dosage types. The Product Development Manager will work closely with internal and external manufacturing partners and contract manufacturers to ensure the products developed and manufactured meet the expectations of multiple regulatory authorities. The Product Development Manager will provide leadership to project teams and will manage outside resources. The Product Development Manager will provide technical expertise and leadership in the field of pharmaceutical product development, technology transfer and scale-up.
Qualifications include: Advanced degree in pharmaceutical science, chemical engineering or related scientific field with 6+ years of industrial drug product development experience, broad understanding of API formulation and manufacturing development, experience in the CMC sections of regulatory submissions with strong knowledge of FDA and ICH guidelines, knowledge of pharmaceutical products including tablets, capsules, parenterals or semisolids, understanding of method validation, stability testing, process validation, quality assurance and regulatory requirements, excellent verbal and written communication skills, ability to work across functions and companies, enjoy being hands-on with projects and working with partners to understand and overcome the obstacles that arise in projects, a self-motivated and collaborative team player. Some travel may be required.
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