James Murray

About James Murray

Over 4 years of experience in project management of cGMP drug substance manufacturing programs and matrix management of cross-functional teams in the pharmaceutical industry. Proven expertise in overseeing GMP technical transfers (tech transfers), process validations, and ensuring supply chain security while maintaining regulatory compliance within both small molecule, large molecule (biologics) and medical device domains. Core CompetenciesOversight of tech transfers: Over 4 years of experience overseeing incoming tech transfers as the technical lead at the CDMO. Responsible for leading the teams charged with new process implementation, scale-ups, rig changes, and repeat campaign improvements. Collaboration and Leadership: Led teams in a matrix environment (typical core team size of 6) and direct reports (up to 2). Coached and mentored earlier career professionals, graduate students and interns throughout my career. Skilled at stakeholder mapping and management across sites, organizations and cultures. Regulatory knowledge: Oversaw three successful process validations; partnered with SMEs to author regulatory risk assessments and memos to ensure processes remained in a state of regulatory compliance.

Experience

1. Sr Project Manager

   Evonik

   Sep 2022 — Present · Lafayette, IN, US

   Served as end-to-end program lead for GMP drug substance manufacturing, overseeing 4 programs Provided oversight and project management to the tech transfer teams (typically ~2 process teams concurrently, each consisting of ~6 members) starting from laboratory familiarization and lab model development through to commercial API manufacturing.Oversaw three first time campaigns and one rig change/scale up. Three of four campaigns had no major or critical deviations. Ensured the team communicated throughout process implementation and was adequately staffed; coached team members and aligned team on manufacturing strategy.Facilitated weekly client update meetings and higher level internal governance meetings to communicate risks, progress, and align priorities and execution. Provided technical oversight for deviation investigations, ensured client processes were established and maintained in a state of compliance with cGMP and ICH regulations.Tracked Program Financial Performance and alignment with Business Objectives.

Education

• University of Leeds

  MChem, Medicinal Chemistry

  2006 — 2010

• University of Leeds

  Doctor of Philosophy (PhD), Chemistry

  2010 — 2014