Manager, Laboratory Operations – Biologics

Alcami Corporation • Durham, NC

91d

About The Position

The Manager, Laboratory Operations - Biologics is accountable for driving results in a fast-paced environment by providing strategic, technical, and operational leadership for the biologics department of Bioseparations & Mass Spectrometry within Laboratory Operations. 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.

Requirements

• Doctorate degree with 8+ years, or Master’s degree with 10+ years, or Bachelor’s degree with 12+ years of related experience in Chemistry, Biochemistry, or related field.
• 2+ years of previous supervisory experience.
• Experience in development, validation, and verification of analytical testing methods.
• Experience with inspections/audits by regulatory agencies and clients.
• Previous experience within CMO, or CDMO preferred.

Nice To Haves

• Proven experience in CDMO/CMO environment desired.
• Thorough knowledge of GMP requirements and regulatory compliance.
• Understanding of biologics modalities (mAbs, proteins, cell & gene therapies, etc.) and analytical methodology (HPLC/UPLC, electrophoresis, mass spectrometry, AUC, UV/Vis, potency assays, etc.).
• Demonstrated success in building and leading teams, driving operational performance and achieving business growth.
• Excellent communication and interpersonal skills with ability to effectively represent the organization holistically to external clients.
• Demonstrated 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.

Responsibilities

• Acts as the primary point of contact for key biologics clients, ensuring exceptional customer service and responsiveness.
• Oversee analytical services supporting biologics and other large molecules, including bioseparations using a variety of chromatographic and electrophoretic methodologies, characterization, release, stability testing, and other specialty studies.
• Extensive experience with mass spectrometry as applied to biologics, including method development, characterization, troubleshooting of instrumentation, data interpretation, and application of advanced analytical techniques to complex biologics.
• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree
• Number of Employees: 501-1,000 employees