Steven K. MacLeod

Experienced scientist, technical team leader and group leader/manager with outstanding record in bringing pharma product development and maintenance of business issues to closure. Drives efforts for resolution of material, process and product issues based on scientific understanding aligned with Quality and Regulatory constraints. Strong scientific/technical problem-solver providing leadership for investigations with clarity to crisp, effective, implementable solutions. Demonstrated leadership in building/developing/maintaining a scientifically strong/agile group for the development/documentation of understanding around the key chemical and physical attributes of the materials, processes and products for worldwide markets. Extensive experience in pharmaceutical business aspects including novel/proprietary (NDA), generic (ANDA), OTC and nutritional products. Provides strategic and tactical support for chemistry development issues (all phases), process development (partnering in QBD and scale/equipment changes), CMC filing support, specification development as well as hands-on engagement for maintenance of business issues ranging from OOS and CAPA, through regulatory changes, to supply chain continuity.