Carrie Wilson

About Carrie Wilson

Over 20 years sterile processing experience in the pharmaceutical industry leading teams in research and development, tech transfer, scale-up, engineering and manufacturing. This includes working closely with roles in operations, process automation, MEDA, supply chain, validation, quality, regulatory, and safety. I am currently working as a Associate Director Manufacturing managing teams of people and improving processes to achieve sustained business performance through innovative thinking, strong leadership and an exceptional focus on customer service.• Subject matter expert in solid and liquid sterile formulation, process development, scale-up, validation and manufacturing• Experienced managing teams, projects and external contract organizations • Good understanding of regulatory aspects of product development, QbD principles and supporting PAIs• Knowledgeable in design of experiments (DOE) • Experience implementing operational excellence and lean manufacturing initiatives• Adept at developing scientific, operational and leadership strategy • Excellent oral and written communication skills and effective presentation skills• Enthusiastic and dedicated team player with good interpersonal skills

Experience

1. Associate Director, Manufacturing

   Alkermes

   Mar 2020 — Present · Wilmington, OH, US

   Lead a team consisting of Process Engineers, Process Technologist, Compliance Specialist, Manager, Supervisors, and Operators to support production of sterile injectable LAI ensuring all CQA and CPPs are met. Oversight of investigations into deviations and non-conformances. Budget planning and adherence.Responsible for manufacturing support for deployment and operation of the PAS-X Manufacturing Execution System (MES). Lead a team consisting of a Supervisor and MES Specialists for implementation of Electronic Batch Record system to reduce manual entries and operator errors associated with traditional paper batch records. Team is responsible for developing, validating, and maintaining the EBRs used to manufacture pharmaceutical products. Team provides technical support encountered with execution of electronic records.

Education

• Wright State University

  BS, Biological Sciences

  1994 — 1997

Skills

• Sterilization
• Cleaning Validation
• 21 Cfr Part 11
• Capa
• Corrective and Preventive Action (Capa)
• U.s. Food and Drug Administration (Fda)
• Deviations
• Quality Assurance
• Continuous Improvement
• Formulation
• Cgmp Manufacturing
• Sop
• Fda
• Validation
• Computer System Validation
• Manufacturing
• Technology Transfer
• Process Validation
• Trackwise
• Change Control
• Documentation
• Quality System
• Quality Systems
• V&V
• Aseptic Technique
• Cgmp
• Gxp
• Aseptic Processing
• Lims
• Cross-Functional Team Leadership
• Biopharmaceuticals
• Quality Control
• Glp
• Gmp
• Software Documentation
• Cgmp Practices
• Pharmaceuticals