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Director of Laboratory Operations (Morrisville)

Director of Laboratory Operations (Morrisville)

Accentuate StaffingMorrisville, NC, United States
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Accentuate Staffing is partnering with an innovative biopharmaceutical organization who is hiring for a Director, Laboratory Operations Biologics. This is a direct hire opportunity offering competitive pay and excellent benefits, working onsite. The ideal candidate is a strategic and collaborative leader with extensive experience in biologics development, laboratory operations, and team leadership within a GMP-regulated CDMO environment.

Responsibilities :

  • Provide leadership and strategic direction for Biologics programs, including Bioseparations, Mass Spectrometry, and Bioassay teams.
  • Develop and execute growth strategies to expand biologics capabilities, revenue, and market share.
  • Partner with Business Development to support client discussions, proposals, and presentations.
  • Oversee analytical testing services, including bioassays, characterization, stability, and release testing.
  • Ensure projects are completed on time, within budget, and to the highest quality standards.
  • Drive innovation, operational efficiency, and continuous improvement across laboratory functions.
  • Lead, mentor, and develop a high-performing team through coaching, technical training, and performance management.
  • Maintain compliance with all GMP, regulatory, and company quality standards.
  • Monitor laboratory performance and establish KPIs to ensure consistent operational success.

Requirements :

  • Bachelors, Masters, or Doctorate degree in Biochemistry or related scientific discipline (advanced degree preferred).
  • 12+ years of experience in pharmaceutical or biologics laboratory operations, with 6+ years in leadership roles.
  • Proven success working within a CDMO / CMO environment.
  • Strong knowledge of biologics modalities (mAbs, proteins, cell & gene therapies) and analytical methodologies (HPLC / UPLC, Electrophoresis, Mass Spectrometry, ELISA, Potency Assays, etc.).
  • In-depth understanding of GMP regulations, quality systems, and regulatory compliance.
  • Excellent communication, client relationship management, and team leadership skills.
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    Director Laboratory • Morrisville, NC, United States