Kenneth Lariviere

About Kenneth Lariviere

Over 30 years of experience in the pharmaceutical industry (predominately biopharmaceutical) including- Technical expert on quality and compliance consulting projects to pharmaceutical, biologics, and medical device companies, and - Capital Project Team Leader on several major vaccine expansion projects at Merck West Point facility, and - Experience preparing for the implementation of SAP, with a leadership role in the plant maintenance workstream, and - Executive level experience managing biotech facilities and support services, and - Extensive experience managing and executing both process and facility related projects (both small molecule and biologics), as well as the management of maintenance activities for both facilities and equipment (process and utility). Demonstrated skill in completing major capital projects on time and within budget.Proven ability to recruit, train, evaluate, motivate, and lead successful teams of engineers.Specialties: Engineering leadership, cGMP facility compliance and management, Capital project leadership

Experience

1. Head of Engineering

   Andelyn Biosciences

   Jun 2021 — Present · Columbus, OH, US

   Andelyn Biosciences is a World Leader in Gene Therapy Contract Development and Manufacturing (CDMO). As a member of the company leadership team I am responsible for all Engineering, Maintenance, and Validation activities on three sites in the greater Columbus area.• Led the construction, start-up, commissioning, and validation of a 180K Sq.Ft. GMP Commercial manufacturing facility / Corporate Headquarters. Greenfield site includes 15 ISO7 clean rooms, a semi-automated filler, process and plant utility systems, QC laboratories, and office space.• Led the design, construction, and start-up of a 21K Sq.Ft. development center. The site includes non-GMP Viral Vector manufacturing (suspension and adherent processes), Process development labs, Analytical Development labs, and office space.

Education

• Villanova University

  Bachelor's degree, Chemical Engineering

• Villanova University

  BChE

• Rutgers University

  MBA, Finance

• The Moses Brown School

  High School Diploma

Skills

• Cgmp
• Capital Projects
• Engineering Management
• Vaccines
• Biotechnology
• Facilities Management
• Project Execution
• Team Leadership
• Cross-Functional Team Leadership
• Engineering Leadership
• Biopharmaceuticals
• Problem Solving
• Talent Management
• Project Engineering
• Gmp
• Project Management
• Validation
• Leadership
• Manufacturing
• Pharmaceutical Industry
• Capa
• Change Control
• Quality Assurance
• Engineering
• 21 Cfr Part 11
• V&V
• Sop
• Gxp
• Technology Transfer
• Aseptic Processing
• Quality System