Director, Laboratory Operations - Biologics

Alcami Corporation-posted 3 months ago
Full-time • Senior
Durham, NC
501-1,000 employees
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The Director, Laboratory Operations - Biologics is accountable for driving results in a fast-paced environment by providing strategic, technical, and operational leadership for the Biologics department within Laboratory Operations. The Director, Laboratory Operations - Biologics is responsible for the success of site operations and achieving company goals. This position requires a balance of scientific expertise, business acumen, and customer focus to ensure high-quality services, efficient execution, and sustained growth. The ideal candidate will be a collaborative leader with a proven track record in biologics development and testing, who thrives in a client-driven CDMO environment.

  • Provide overall direction and leadership for biologics programs in the Bioseparations, Mass Spectrometry, and Bioassay teams within laboratory operations, ensuring alignment with company strategy and client expectations.
  • Develop and implement a biologics growth strategy to expand capabilities, revenue, and market share.
  • Partner with Business Development to support client presentations, proposals, and scientific discussions.
  • Acts as the primary point of contact for key biologics clients, ensuring exceptional customer service and responsiveness.
  • Oversee analytical services supporting biologics, including bioassays, bioseparations, characterization by mass spectrometry and other pertinent methodologies, release, stability testing, and other specialty studies.
  • Provide technical and regulatory expertise for biologics method establishment and testing strategies across all phases of development.
  • Translate client needs into actionable project plans while balancing scientific rigor with business requirements.
  • Serve as subject matter expert in Biologics for internal and external stakeholders.
  • Formulate and implement policies that meet compliance and operational expectations.
  • Ensure projects are executed on time, on budget, and to the highest quality standards.
  • Lead capacity planning, resource allocation, and prioritization of biologics projects across the analytical team.
  • Drive operational efficiency, technical advancements, and laboratory innovation.
  • Foster a culture of quality, compliance, scientific excellence, and continuous improvement.
  • Drive professional development, technical training, and succession planning for staff.
  • Attract, develop, and retain a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
  • Promote a collaborative and innovative environment that encourages problem-solving and accountability.
  • Ensure adherence to SOPs, training and other regulatory requirements.
  • Stays current on industry and regulatory laboratory trends and adapts the quality systems, practices and procedures, as necessary.
  • Develop and report metrics and key performance indicators to monitor laboratory compliance and performance.
  • Other duties as assigned.
  • Bachelor, Master, or Doctorate degree in Biochemistry or other science-related field; Advanced degree preferred.
  • 12+ years of pharmaceutical laboratory experience with 6+ years experience in people leadership roles.
  • Proven experience in CDMO/CMO environment required.
  • Thorough knowledge of GMP requirements and regulatory compliance.
  • Strong understanding of biologics modalities (mAbs, proteins, cell & gene therapies, etc.) and demonstrated experience with relevant analytical methodologies (HPLC/UPLC, Electrophoresis, Mass Spectrometry, ELISA, Potency Assays, etc.).
  • Demonstrated success in building and leading teams, driving operational performance and achieving business growth.
  • Excellent communication, negotiation, and interpersonal skills with ability to effectively represent the organization holistically to external clients.
  • Strong business acumen with ability to balance scientific excellence and commercial priorities.
  • Demonstrated experience representing analytical or biologics operations during regulatory inspections.
  • Strong organization and management skills required.
  • Record of accomplishment in change management and proven ability to build teams.
  • Self-motivated with high-energy and an entrepreneurial team spirit, willing to get 'hands on' to build the business.
  • Excellent written and verbal communications and presentation skills required.
  • Strong skills with Microsoft Office (Word, Excel, and PowerPoint) required.
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