Jeremy Bollinger

About Jeremy Bollinger

I have worked in the Biotech and Pharmaceutical industry for 17 years. I began my career in manufacturing operations working in Clarification and Purification areas as a lead for 7 years. I have knowledge of chromatography (including column packing), viral filtration, ultrafiltration, and bulk dispensing. As a manufacturing associate, I assisted the full start up of various processes in the Purification area as part of tech transfer.Following my work in manufacturing, I transitioned to the validation department. I worked in the validation group for approximately 9 years and have extensive knowledge and understanding of IQ/OQ/PQ requirements for facilities (HVAC), utilities (water systems, gases, etc), and processing equipment (cleaning, sterilization, etc). While in this role, I have helped implement significant changes to improve processes. Examples include, modifying elastomer replacement program, implementing worst-case soil analysis, and streamlining the overall CQV approach. I supported the start up of two international facilities, one being in Denmark (two year expat assignment) and the second in Switzerland. Outside of my daily job requirements, I have served as an active team member and leader participating in the CIP summit and multi-product facility BPOG workstream. As a senior engineer in validation, I served as a matrix manager of validation engineers responsible for coaching, development planning, and building a high performing team. In my current role as QA Systems Manager, my focus has transitioned to leading an empowered team in document management, inspection management, Quality Control oversight, quality metric management (reporting), business process owner of quality systems, and quality oversight of recipe driven operations. Servant leadership is my focus to motivate and engage the team to push beyond what we thought was capable, while building lasting and effective relationships.

Experience

1. Qa System Manager

   Biogen

   Oct 2018 — Present

Education

• Virginia Tech - Pamplin College of Business

  Bachelor of Science - BS, Marketing/Marketing Management, General

  1998 — 2002

Skills

• V&V
• Sop
• Fda
• Validation
• Gmp
• Glp
• U.s. Title 21 Cfr Part 11 Regulation
• Change Control
• Biopharmaceuticals
• Biotechnology
• Gxp
• Aseptic Processing
• Lims
• 21 Cfr Part 11
• Corrective and Preventive Action (Capa)
• Capa
• Standard Operating Procedure (Sop)
• Verification and Validation (V&V)