Daniel Lanfear

About Daniel Lanfear

I am a Director‑level pharmaceutical manufacturing and process development leader with deep experience spanning biologics and small‑molecule drug substance, from early development through commercial GMP production.My background includes large‑scale microbial fermentation and downstream processing, biologics manufacturing (including EPOGEN™ at Amgen), and small‑molecule and high‑potency operations. I have led process development, MSAT, technology transfer, scale‑up, validation (IQ/OQ/PQ), and manufacturing support across global and external manufacturing networks.I bring a rare combination of hands‑on technical depth and senior leadership experience, having built and led engineering, MSAT, and operations teams while partnering closely with Quality, Regulatory, R&D, and external CMOs/CDMOs. My work consistently focuses on improving robustness, yield, and manufacturability while ensuring compliance in cGMP environments.Core areas of expertise include:Biologics process development and fermentation gal scale)Drug substance MSAT and manufacturing sciencesProcess scale‑up, tech transfer, and lifecycle managementExternal manufacturing and CMO oversightGMP operations, validation, deviations, and continuous improvementI am particularly interested in remote or hybrid Director‑level roles where I can contribute across process engineering, MSAT, and manufacturing leadership in biologics and/or small‑molecule pipelines.

Experience

1. Director Operations, Strategic Projects & Engineering and Operational Excellence

   Piramal Pharma Solutions

   Jan 2025 — Present · Detroit, MI, US

   Director‑level leader responsible for manufacturing, MSAT‑adjacent process support, engineering, and technology transfer within a GMP pharmaceutical manufacturing environment supporting complex small‑molecule and advanced processes.Lead cross‑functional teams spanning manufacturing, engineering, facilities/maintenance, logistics, and technology transfer, supporting reliable GMP production and continuous improvement.Provide process engineering and MSAT‑style technical leadership to resolve manufacturing challenges, improve robustness, and support scale‑up, change implementation, and lifecycle management.Partner closely with Quality, Regulatory, MSAT, Process Development, and Business stakeholders to ensure compliant execution of process changes, deviation resolution, and manufacturing readiness.Drive strategic and operational projects delivering measurable improvements in yield, reliability, safety, and cost, while maintaining strict cGMP compliance.Support external vendors and service providers, ensuring alignment with GMP expectations, technical requirements, and business objectives.Lead and mentor multidisciplinary technical teams, balancing hands‑on technical engagement with executive‑level decision‑making and prioritization.Key Focus Areas:Manufacturing Leadership • Process Engineering & MSAT Support • Technology Transfer • GMP Operations • External Manufacturing Interface • Continuous Improvement • Cross‑Functional Leadership

Education

• Colorado State University

  MBA, Business Administration

• Oakland University

  Bachelor of Science (B.S.), Biochemistry

• Wayne State University

  Master of Science (MS), Chemical Engineering