Head of SMS Drug Substance

Role Summary

Head of SMS Drug Substance, located in Framingham, MA. Lead the Operational Excellence (OpEx) program for the site Drug Substance organization, serving as the SMS Leader and primary business partner for SMS methodology, training, and deployment. Require SMS Intermediate level certification at minimum and drive the execution of performance initiatives and SMS operating standards while solving problems through root-cause analysis.

Responsibilities

• Knowledge of SMS operating standards (certification) and main Operational Excellence techniques (e.g., GPS3, Lean, Six Sigma, Agile, CI, etc.)
• Experience in transformation and change management
• Understand finance P&L monitoring, BOI, GM, COGs, cash flow, etc.
• Good understanding of data management and IA digital products embedded into the SMS operating standards (e.g., eOEE, FaCT, iObeya)
• Ability to manage cross-departmental, cross-domain projects
• Communication skills (verbal and written) with technical and operational fluency
• Good listening and interpersonal skills (strong relationships with Department Leaders)
• Capacity to anticipate problems and organize proactive countermeasures

Qualifications

• Required: Bachelor’s degree in Business, Engineering, Operations, Biology, Chemistry, Computer Science, Data Science or similar relevant disciplines.
• Required: Minimum of 3 years of experience in a Pharma/Bio setting, preferably in a GMP manufacturing environment.
• Preferred: Successful, multi-year track-record of managing complex, cross-functional Operational Excellence / lean initiatives or transformations.
• Preferred: Technical background (e.g., manufacturing, engineering, data science, finance).

Skills

• SMS operating standards knowledge (certification) and Operational Excellence techniques
• Transformation and change management experience
• Finance acumen (P&L monitoring, BOI, GM, COGs, cash flow)
• Data management and IA digital tools embedded in SMS standards (eOEE, FaCT, iObeya)
• Cross-functional project management
• Effective communication (verbal and written) with technical/operational teams
• Strong listening and interpersonal abilities
• Proactive problem identification and countermeasure planning

Education

• Bachelor’s degree in Business, Engineering, Operations, Biology, Chemistry, Computer Science, Data Science or similar relevant disciplines

Additional Requirements

• Up to 15% international travel
• Ability to work in clean room spaces