Director, Laboratory Operations - Biologics , Mass Spectrometry and Bioseparation

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:30am - 5:30pm.

Responsibilities

• 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.
• Arrive, 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.

Qualifications

• 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.