`Sr. Engineer / Technical Team Leader
`
`Summary
`Experienced Chemical Engineer with over 20 years (15+ pharmaceutical, 6+ consumer products) of
` combined formulation development and process development expertise. Techncial and leadership
` experience has bridged entire life cycles for complex pharmaceutical dosage forms including early
` stage development; process scale-up and technology transfer; commercial start-up; and commercial
` support and optimization.
`
`Experience
`Process Pharmacist Specialist at Patheon Inc.
`2012 - Present
`
`Sr. Principal Engineer / Associate Director at Alkermes
`1996 - 2012 (17 years)
`• Designed scalable platform processes for sterile GMP manufacturing.
`• Led scale-up and technology transfer programs from R&D to manufacturing.
`• Developed intellectual property including over 20 US patents.
`• Supervised pharmaceutical scientists and engineers in multidisciplinary team settings.
`• Interacted with FDA and global regulatory authorities including site inspections.
`• Authored development sections of INDs and NDAs.
`• Utilized Quality by Design (QbD) and statistical Design of Experiments (DOE) methodologies.
`• Created a Technical Services group with expertise in SPC and process optimization.
`• Created departmental and capital budgets and developed manufacturing cost models.
`• Created development plans for external pharmaceutical partners and internal programs.
`• Key communication interface with multiple external pharmaceutical partners.
`
`Process Development Engineer
`1993 - 1996 (4 years)
`
`Scientist, Research and Development
`1987 - 1993 (7 years)
`• Led Product and Process Development of consumer products including Windex and Renuzit
`brands.
`
`Education
`University of Dayton
`
`APOTEX EXHIBIT 1054
`Apotex v. Alkermes
`IPR2025-00514
`
`Page 1
`
`
`
`Bachelor, Chemical Engineering
`Activities and Societies: Designated University Scholar, Engineering Co-op program
`
`Page 2
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`
`
`Steve Wright
`Sr. Engineer / Technical Team Leader
`
`Contact Steve on LinkedIn
`
`Page 3
`
`
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