Accentuate Staffing
Director of Laboratory Operations
Accentuate Staffing, Morrisville, North Carolina, United States, 27560
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:
Bachelor’s, Master’s, 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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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:
Bachelor’s, Master’s, 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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