Michael McGlynn

About Michael McGlynn

A proven technical operations leader with experience in overseeing and supporting products and projects, global initiatives and personnel of leading human health and animal health biopharmaceutical organizations. Extensive background in drug product and process development, process validation, technology transfer, commercialization and lifecycle portfolio management including change controls, CPV, process capability assessments and process improvements. Experienced in cultivating alliances with internal stakeholders and external partners and leading multidisciplinary teams in fast-paced, highly-matrixed global work environments. Experienced in program management initiatives and developing & implementing new business processes. CMC subject matter expert for oral solid dosage forms, liquids, ointments & creams and other product types spanning branded and generic products, Rx and OTC, vitamins, and cosmetics. Skilled at managing CMOs and API suppliers. Background in new facility start-ups, equipment procurement and qualification, as well as authoring, reviewing and approving CMC sections of new drug applications & supplements, responses to health authority questions and inspection readiness in support of global regulatory submissions. Ability to manage multiple high-priority projects with a high degree of effectiveness. A pragmatic, solution-oriented thinker with a “can do” and “whatever it takes” attitude, coupled with strong organizational skills. A motivator, listener, and collaborator with strong communication skills and the ability to connect with all levels of the organization. Core Competencies include:Leadership, Coaching & Mentoring, Collaboration and Personnel Management | Program/ Project Management | Pharmaceutical Early Development Through Commercialization Program Phases & Technical/ Regulatory Requirements | Product & Process Development | Technology Transfer | Product Lifecyle Management | cGMP Manufacturing | CMO Relationships & Technical Oversight | Process & Cleaning Validation and CPV | Change Management | Deviation Investigations & Root Cause Analysis | Drug Product & Drug Substance Manufacturing Principles & Unit Operations | Due Diligence

Experience

1. Senior Advisor - Technical Services Manufacturing Science

   Elanco

   Apr 2023 — Present · US

   Leading a team of technical professionals providing TS/MS functional oversight across global Small Molecule Network sites and External Manufactuing along with central TS/MS stewardship, expertise and support across all networks.

Education

• Massachusetts Institute of Technology

  MS, Chemical Engineering

• University of Massachusetts Amherst

  BS, Chemical Engineering

Skills

• Pharmaceutical Industry
• Gmp
• Technology Transfer
• Validation
• Fda
• Quality by Design
• V&V
• 21 Cfr Part 11
• Sop
• Capa
• Change Control
• Cross-Functional Team Leadership
• Biotechnology
• Biopharmaceuticals
• Drug Delivery
• Drug Development
• Formulation
• Manufacturing
• Pharmaceutical Manufacturing
• Pharmaceutics
• Product Development
• R&D
• Regulatory Affairs