Associate Director / Senior Manager

📋 Description

• Day to day activity oversight of commercial DP CMOs for small molecule solid-oral dose
• Holds teleconferences with CMO and suppliers; takes meeting minutes, tracks action items, creates
• Leads or supports documentation review and approval (MBRs, specs, methods), change controls and
• Oversees investigations related to deviations and complaints, with proper evaluation of impact to
• Identifies and leads key process problem resolution activities and process improvement initiatives
• Create and disseminate technical transfer information and documents required by CMOs for

🎯 Requirements

• BS/MS (Life Sciences, Engineering) with at least 5-7 years relevant experience in commercial bulk
• CMO management or experience within manufacturing plant (experience in commercial manufacturing
• Experience in formulation development, process validation and tech transfer in support of marketing
• Project leadership experience with cross-functional CMC experience. Ability to effectively
• Familiarity with FDA and ICH guidelines, such as 21CFR210 and 211, and thorough understanding of
• Understanding of supplier performance management (KPI, quality metrics, adherence to supply and

🎁 Benefits

• Market-leading compensation
• 401(k) with employer match
• Employee Stock Purchase Program (ESPP)
• Pre-tax commuter benefits (transit and parking)
• Referral bonus for hired candidates
• Subsidized lunch and parking on in-office days