Principal Manufacturing Innovation Strategist
Core
Shape manufacturing strategy, evaluate technologies, and develop capital projects to improve compliance, quality, capacity, and cost for biologics and small-molecule API production.
Role type
Principal Manufacturing Innovation Strategist
Builds
Manufacturing strategy, capital plans, and enterprise-wide manufacturing initiatives
Domain
Biopharmaceutical manufacturing (biologics, ADC, mRNA, LNP, small molecules)
Required skills
GMP compliance, process scale-up, technology transfer, capital project leadership, financial modeling, lifecycle management, regulatory strategy
Preferred skills
MBA, Professional Engineer (P.Eng.) designation, expertise in biologics and small-molecule API production
Technologies
GMP, Annex 1, ICH guidance, FDA/EMA/Health Canada regulatory frameworks
Responsibilities
Provide technical leadership and mentorship to engineering teams; Guide process scale-up and facility modifications; Develop 3-5 year manufacturing and capital plans; Evaluate facility expansions and strategic partnerships; Lead major capital projects from concept to qualification; Develop business cases and ROI models; Resolve complex enterprise-level engineering challenges
Seniority
Principal, strategy & mentorship