Dana Hansen

About Dana Hansen

Passionate, result oriented, science-focused, distinguished leader with extensive knowledge of end to end manufacturing with an emphasis on products, processes, operations, innovation and strategy.Strong experience and expertise in product development, quality management, manufacturing operations, operational excellence (OE) and executive leadership.I excel at leading cross-functional teams in developing and launching multiple products, with additional accountability for mergers and acquisitions, licensing, external innovation/manufacturing and global collaborations.Highlights:•30 years of Pharmaceutical Manufacturing experience.•Shawnee Site Leadership Team for14 consecutive years.•Participate in pricing committee meetings, customer proposal creation and review, technical service agreements(TSA) and master service agreements.(MSA)•Oversee $20MM operations budget and overall site revenue budget of $105MM.•Deep knowledge of Audit and Operation processes related to business requirements defined by FDA, EU, DEA,EPA, OSHA, and other regulatory agencies.•Exceptional understanding of aseptic/sterile processing, sterile gowning, clean rooms, fermentation techniques, solid dose and soft chew products, non-sterile liquids as well as pastes and suspensions.

Experience

1. General Manager

   Plastikon Healthcare, Llc

   Aug 2024 — Present · Lawrence, KS, US

Education

• Bayer Operational Excellence

  Black Belt Certification, Lean Manufacturing

• Nebraska Wesleyan University

  Bachelor of Science - BS, Biology

  1989 — 1993

Skills

• Capa
• Gmp
• Quality System
• V&V
• 21 Cfr Part 11
• Biopharmaceuticals
• Gxp
• Manufacturing
• Aseptic Processing
• Change Control
• Cleaning Validation
• Validation
• Computer System Validation
• Pharmaceutical Industry
• Sop
• Fda
• Glp
• Biotechnology
• Technology Transfer
• Regulatory Affairs
• Lean Manufacturing