Director, Chemistry Manufacturing and Controls
Main Duties and Responsibilities
- 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 deviations, investigations and CAPAs and make recommendations to Quality Assurance
- Review and approve technical drug substance and drug product documents for regulatory submissions, ensuring all documentation is approved and processed within budget and timeline
Education, background, knowledge and skills
- MS or PhD in Pharmaceutics, Pharmaceutical Chemistry, Medical 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 required, 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; and
- Experience with project management tools including Excel, PowerPoint, Project Team and Acrobat
- 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.
Milestone Pharmaceuticals is an equal opportunity employer
Disclaimer: The above declarations are not intended to be an all-inclusive list of the duties and responsibilities of the job described, but rather are intended only to describe the general nature of the position.