Director, Industry Specialty Services

Director, Industry Specialty Services leads consulting projects across CMC and regulatory-related fields including product development, bioprocess development, analytical and formulation development, manufacturing strategy and operations, quality control and quality assurance, regulatory compliance, and market research. The role involves client interaction, potential project authority, and contribution to internal firm initiatives such as the bioTRAK database and cost modeling. Responsibilities include conducting market research, technology assessments, due diligence, coordinating with vendors and clients, drafting regulatory and quality documentation, auditing CMOs/CROs under supervision, supporting business development and external representation at conferences, writing blogs and surveys, and helping upgrade internal assets and reporting. Supervisory duties include overseeing engagements and junior staff. Requires a Bachelor's degree in life sciences/engineering; advanced degree preferred; seven years in pharma/biopharma with CMC experience and experience with regulatory submissions is preferred. Strong communication, analytical, and multi-tasking abilities, with ability to work independently or in a team and to meet deadlines.