Charlie Hitscherich

Experienced Biopharmaceutical Leader

Role
Head of External Operations at Alnylam Pharmaceuticals
Location
Boston, MA, US
LinkedIn followers
500 followers

About Charlie Hitscherich

Entrepreneurial biotechnology leader skilled in developing and commercializing biotechnology products. Experienced cross-functional matrix lead with a history of building successful external partnerships and managing alliances. Actively contributed to the commercialization of five biologic parenteral drugs, five siRNA therapies, two combination products, and one oral solid dose small molecule. Sound knowledge of program management, cGMP manufacturing, phase-appropriate drug /device development, aseptic manufacturing, process validation and end to end global supply chain requirements. Strong communication skills and ability to convey complex technical concepts and solutions to technical and non-technical audiences.Leadership Skills: Building high performing teams Managing change in fast paced environments Growing and developing talent Driving innovation in a matrix environment Program and alliance management Developing and building external partnershipsSpecialties Biologic and Oligonucleotide DS and DP cGMP manufacturing Drug product and combination product development Process transfer, scale up, and validation Management of contract manufacturers BLA and NDA authoring Global supply and distribution

Experience

  1. Head of External Operations

    Alnylam Pharmaceuticals

    Jan 2021 — Present

    Department Head responsible for manufacturing of Alnylam’s Specialty Raw Materials, API, and Drug Product as well as management of CMC activities in support of programs partnered with Pharma and Biotech Alliance Partners.

Education

  • D'Amore-McKim School of Business at Northeastern University

    Master of Business Administration (M.B.A.)

  • Commonwealth University-Lock Haven

    Bachelor’s Degree, Physics

  • University of Iowa

    Doctor of Philosophy (Ph.D.), Chemical and Biochemical Engineering

  • Penn State University

    Bachelor’s Degree, Chemical Engineering

Skills

  • Gmp
  • Drug Development
  • Biopharmaceuticals
  • Pharmaceutical Industry
  • Sop
  • Fda
  • Validation
  • Biotechnology
  • Change Control
  • Commercialization
  • Technology Transfer
  • Cross-Functional Team Leadership
  • R&D
  • Clinical Development
  • Life Sciences

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Charlie Hitscherich — Head of External Operations at Alnylam Pharmaceuticals in Boston, MA, US | Unifers