Manager Of Laboratory Operations – Biologics

Description

• Stay current on industry and regulatory laboratory trends and adapt quality systems, practices, and procedures accordingly.
• Apply extensive experience with mass spectrometry to biologics, including method development, characterization, and data interpretation.
• Lead capacity planning, resource allocation, and prioritization of biologics projects across the analytical team.
• Attract, develop, and retain a high-performing team through effective selection, training, coaching, mentoring, and performance management.
• Promote a collaborative and innovative environment that encourages problem-solving and accountability.
• Oversee analytical services supporting biologics, including bioseparations, characterization, release, stability testing, and specialty studies.
• Ensure projects are executed on time, within budget, and to the highest quality standards.
• Foster a culture of quality, compliance, scientific excellence, and continuous improvement.
• Serve as a subject matter expert in Biologics for internal and external stakeholders.
• Drive professional development, technical training, and succession planning for staff.
• Act as the primary contact for key biologics clients, ensuring exceptional customer service and responsiveness.
• Drive operational efficiency, technical advancements, and laboratory innovation.
• Translate client needs into actionable project plans, balancing scientific rigor with business requirements.
• Ensure adherence to SOPs, training, and other regulatory requirements.

Requirements

• Experience with capillary electrophoresis for charge variant analysis and glycan profiling.
• Deep hands-on experience with mass spectrometry for biologics characterization.
• Previous experience within CMO or CDMO preferred.
• Experience in development, validation, and verification of analytical testing methods.
• Experience with inspections/audits by regulatory agencies and clients.
• Experience in a pharmaceutical GMP environment required.
• Familiarity with biologic modalities such as monoclonal antibodies, peptides, oligonucleotides, and cell/gene therapies.
• 2+ years of previous supervisory experience.
• Doctorate degree with 8+ years, or Master’s degree with 10+ years, or Bachelor’s degree with 12+ years in Chemistry, Biochemistry, or related field.
• Strong command of HPLC techniques for purity, potency, and stability testing.

Benefits

• Competitive salary.
• Medical, dental, and vision insurance

Training + Development

Interview process

Visa Sponsorship

Security clearance