Laboratory Operations Director - Biologics

Job Title: Operations Director - Biologics

Essential Skills

• Deep hands-on experience with mass spectrometry for biologics characterization.
• Strong command of HPLC techniques (e.g., SEC, RP-HPLC, IEX) for purity, potency, and stability testing.
• Experience with capillary electrophoresis for charge variant analysis and glycan profiling.
• 12+ years of pharmaceutical laboratory experience with 6+ years in leadership roles.

Additional Skills & Qualifications

• Bachelor, Master, or Doctorate degree in Biochemistry or a related science field; advanced degree preferred.

Job Description

The Director, Laboratory Operations - Biologics is responsible for providing strategic, technical, and operational leadership within the Biologics department. This role demands a balance of scientific expertise, business acumen, and a client-focused approach to ensure the delivery of high-quality services, efficient execution, and sustained growth. The successful candidate will be a collaborative leader with experience in biologics development and testing, thriving in a client-driven CDMO environment.

Responsibilities

• Provide overall direction and leadership for biologics programs in Bioseparations, Mass Spectrometry, and related teams, ensuring alignment with company strategy and client expectations.
• Develop and implement growth strategies to expand biologics capabilities, revenue, and market share.
• Partner with Business Development to support client presentations, proposals, and scientific discussions.
• Act as the primary point of contact for key biologics clients, ensuring exceptional customer service and responsiveness.
• Oversee analytical services for biologics, including bioassays, bioseparations, and mass spectrometry characterization.
• Provide technical and regulatory expertise for biologics method establishment and testing strategies.
• Translate client needs into actionable project plans while balancing scientific rigor with business requirements.
• Serve as a 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, within budget, and to the highest quality standards.
• Lead capacity planning, resource allocation, and prioritization of biologics projects.
• Drive operational efficiency, technical advancements, and laboratory innovation.
• Foster a culture of quality, compliance, scientific excellence, and continuous improvement.
• Promote professional development, technical training, and succession planning for staff.
• Attract, develop, and retain high-performing team members through effective selection, training, and performance management.
• Promote a collaborative and innovative environment that encourages problem-solving and accountability.
• Ensure adherence to SOPs, training, and other regulatory requirements.
• Stay current on industry and regulatory laboratory trends, adapting quality systems and practices as necessary.
• Develop and report metrics and key performance indicators to monitor laboratory compliance and performance.

Work Environment

This position is based in a new site expansion with a 20,000 square feet facility. The role involves hands-on leadership in a dynamic and collaborative environment focused on scientific rigor, continuous improvement, and cross-functional collaboration.

Job Type & Location

This is a Permanent position based out of Durham, North Carolina.

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This is a Permanent position based out of Durham, NC.

The pay range for this position is $170000.00 - $200000.00/yr.

- Competitive salary. - Medical, dental, and vision insurance - 401(k)

This is a fully onsite position in Durham,NC.

This position is anticipated to close on Dec 24, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.