Associate Director – TS/MS Validation

Role Summary

Associate Director – TS/MS Validation. Responsible for staffing, training, and leadership of the Technical Services/Manufacturing Science TS/MS validation group, including cleaning validation, sterilization validation, filter validation, controlled temperature storage qualification, and qualification of equipment, facilities, and utilities. Supports day-to-day TS/MS validation activities and plans for the 3-6 month horizon.

Responsibilities

• Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including interactions of chemistry, equipment, aseptic processes, and container closure systems.
• Support Site Leadership to build a diverse and capable TS/MS organization across validation areas.
• Provide technical guidance to the TS/MS group.
• Participate in strategies for Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).
• Support site inspection readiness and execution; interact with Regulatory Agencies during site inspections.
• Manage external contracts/resources and project management resources as needed.
• Develop and maintain validation program documents including SOPs and Master Plans.
• Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, and validation master plans.
• Lead TS/MS technical projects to improve start-up, process control, yield, product quality, and productivity.
• Work within or lead cross-functional teams to implement TS/MS validation objectives and deliver on business and quality objectives.
• Network and collaborate with global and other parenteral sites to share knowledge and plan strategically.
• Ensure a safe working environment and participate in safety-related activities.

Qualifications

• BS, MS, or Doctorate in Mechanical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or related scientific discipline
• Minimum 1 year of management or leadership experience with cross-functional groups
• Minimum 5 years of regulated industry experience
• Previous experience with aseptic manufacturing

Additional Skills

• Strong technical aptitude with ability to train and mentor others
• Excellent interpersonal, written, and oral communication skills across organizational levels
• Solid understanding of regulatory requirements from FDA, EMEA, OSHA
• Experience supporting cGMP manufacturing in operations, Technical Services/MSAT, QA, etc.
• Facility or area start-up experience
• Equipment qualification and process validation experience
• Experience with highly automated equipment
• Experience with deviation and change management systems (e.g., MasterControl)

Education

• Degree in relevant field as listed in Qualifications

Additional Requirements

• Role is Monday through Friday with flexibility to support production schedules, occasional extended hours or off-hour work as required