Associate Director - Chemistry Manufacturing & Controls
October 22
Description
• Management of the pharmaceutical development of drug substance and drug products at contract manufacturing organizations (CMOs) intended for nasal and sublingual administration • Collaborate with internal teams, consultants, CMOs and suppliers, providing project management oversight for CMC, and in accordance with development plans • Execute external development and manufacturing activities at CMOs, ensuring collaboration, communication, scientific expertise, and attention to detail • Manage formulation and analytical development activities for current and future CMC projects • Act as a subject matter expert on reformulation of existing products and development of new formulations and delivery systems • Review essential elements of scale-up and technology transfer • Manage the technical oversight and timeline of outsourced activities • Apply technical expertise to support the development of new formulations, and manufacturing processes for nasal, sublingual, and transdermal dosage forms • Review batch production records and development protocols to ensure cGMP compliance • Review and approve drug substance and drug product documents for regulatory submissions (NDA, MAA etc)
Requirements
• MS or PhD in Pharmaceutics, Pharmaceutical Chemistry, or Chemical Engineering • Approximately Ten years of experience in the pharmaceutical industry or CMO’s including virtual pharmaceutical development with direct CMC experience • Experience with the management of an Investigational Medicinal Product (IMP) • Experience working with drug substance, and drug product contract manufacturers in the US, EU and Asia • Experience with intranasal and sublingual drug delivery systems for formulation and manufacturing is preferred, as is experience with drug/device combinations • Knowledge of formulation development, analytical development, technology transfer, GXPs, FDA, EU, and ICH regulation/guidelines, as well as CMC content of regulatory submissions • Experience with project management tools including Excel, PowerPoint, Project, Teams and Adobe • Superior interpersonal abilities—including working in a multi-cultural, multi-lingual environment • Exceptional communication skills, with both written and oral presentation abilities • Demonstrated ability to successfully work with and influence contract manufacturing partners while maintaining positive working relationships • Able to travel approximately15% of the time, including international travel when appropriate • Located in or willing to relocate to Montreal or Charlotte; or located in the Raleigh or New Jersey area
Benefits
• Competitive Health, Dental, and Vision Insurance • Flexible Spending Account • Orthodontia • Short and Long-term disability • Group-Term Life and AD&D • 401k w/ company match • Paid Time Off • Employee Stock Purchase Plan
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