Chemistry Manufacturing & Controls (CMC) Manager

At Milestone, we are developing anti-arrhythmia treatments for self-administration outside of the emergency department or hospital setting. We are seeking a Chemistry Manufacturing & Controls (CMC) Manager to manage external manufacturing and analytical activities at contract development and manufacturing organizations (CDMOs).

Requirements

• BSc or MSc in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry or related field
• 5+ years of experience in the biotech or pharmaceutical industry with at least 3+ years in cGMP environment
• Hands-on experience with one or more of the following: drug substance/drug product GMP manufacturing, tech transfer, process scale-up and validation, analytical development and validation, formulation development, experience working with CDMOs or contract testing laboratories
• Knowledge of GMP, FDA and EU regulations, ICH guidelines, as well as CMC content of regulatory submissions
• Proficiency with Word, Excel, PowerPoint, SharePoint, Teams and Acrobat

Benefits

• COVID-19 Vaccination Policy: All employees must be fully vaccinated for COVID-19
• Equal Employment Opportunity (EEO) Policy: Milestone does not discriminate in recruitment, hiring, training, promotion or any other employment practices
• Accommodation for Qualified Individuals with Known Disabilities